Page last updated: 2024-12-04

cisplatin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cisplatin, with the chemical formula [Pt(NH3)2Cl2], is a platinum-based chemotherapy drug that has been used to treat various cancers, including testicular, ovarian, bladder, and lung cancer. Its synthesis involves reacting potassium tetrachloroplatinate(II) with ammonia in aqueous solution. Cisplatin's mechanism of action involves binding to DNA, inhibiting its replication and ultimately causing cell death. Its importance lies in its effectiveness against a broad range of cancers, and it has become a cornerstone of cancer treatment. However, it has significant side effects, including nephrotoxicity, ototoxicity, and nausea, which limit its use. Despite these limitations, cisplatin remains a valuable tool in cancer therapy, and ongoing research focuses on understanding its mechanism of action, developing novel platinum-based drugs with reduced side effects, and investigating its potential use in combination therapies.'

Cross-References

ID SourceID
PubMed CID2767
MeSH IDM0004505
PubMed CID5460033
MeSH IDM0004505

Synonyms (83)

Synonym
nsc131558
AC-2109
HMS3268F06
AB00642613-02
CIS ,
cis-diammine-dichloroplatinum(ii)
cis-diaminedichloroplatinum
NEURO_000055
NCGC00090759-01
cis-dichlorodiamine platinum
cis-platinum(ii)
cis-platinum diamminedichloride
nsc-241517
nsc241517
26035-31-4
platinum, diamminedichloro-
replaced cas registry number(s): 14283-03-5
NCGC00090759-02
cisplatin(cis-diammenedichloroplatinum)
trans-dichlorodiammineplatinum.(transplatin)
cis-diamminedichloroplatinum(ii)(cis-ddp)
dichloroplatinumdiamine
bdbm50028111
NCGC00090759-03
cis-diamminedichlorplatine
NCGC00260049-01
tox21_113470
tox21_202500
BCP9000536
tox21_111011
cas-15663-27-1
platinum,diamminedichloro-
HY-17394
CS-1122
tox21_111011_1
NCGC00263537-01
AB00642613_03
AKOS025401526
HMS3654E14
SW222225-1
BRD-K69172251-001-01-4
SDCCGSBI-0050893.P003
BP-25382
lopac-p-4394
NCGC00015812-01
abiplatin
platosin
platinum diamminodichloride
NCGC00162292-01
NCGC00094229-01
cis platinum
dichlorodiammineplatinum
diamminodichloride, platinum
NCGC00162292-02
NCGC00094229-02
platinoxan
dtxsid4024983 ,
cis-platinum ii
tox21_500918
NCGC00261603-01
diammine(dichloro)platinum
NCGC00162292-05
BC164315
placis
cis-diammine-dichloroplatinum
cis-platinous diamine dichloride
cis-diamminedichloro platinum (ii)
platistin
platiran
plastistil
platinol-aq vha plus
cisplatina
citosin
blastolem
platiblastin-s
metaplatin
cysplatyna
cis-dichloroammine platinum (ii)
platinum, diaminedichloro-, cis-
citoplatino
l01xa01
cis-platinum ii diamine dichloride
cis-diamminedichloridoplatinum

Research Excerpts

Bioavailability

ExcerptReferenceRelevance
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (8)

RoleDescription
mutagenAn agent that increases the frequency of mutations above the normal background level, usually by interacting directly with DNA and causing it damage, including base substitution.
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
photosensitizing agentA chemical compound that can be excited by light of a specific wavelength and subsequently transfer energy to a chosen reactant. This is commonly molecular oxygen within a cancer tissue, which is converted to (highly rective) singlet state oxygen. This rapidly reacts with any nearby biomolecules, ultimately killing the cancer cells.
cross-linking reagentA reagent with two reactive groups, usually at opposite ends of the molecule, that are capable of reacting with and thereby forming bridges between macromolecules, principally side chains of amino acids in proteins, allowing the locations of naturally reactive areas within the proteins to be identified.
genotoxinA role played by a chemical compound to induce direct or indirect DNA damage. Such damage can potentially lead to the formation of a malignant tumour, but DNA damage does not lead inevitably to the creation of cancerous cells.
nephrotoxinA poison that interferes with the function of the kidneys.
ferroptosis inducerAny substance that induces or promotes ferroptosis (a type of programmed cell death dependent on iron and characterized by the accumulation of lipid peroxides) in organisms.
apoptosis inducerAny substance that induces the process of apoptosis (programmed cell death) in multi-celled organisms.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
diamminedichloroplatinum
diamminedichloroplatinum
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (93)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency8.64380.003245.467312,589.2998AID2517
Chain A, TYROSYL-DNA PHOSPHODIESTERASEHomo sapiens (human)Potency35.95830.004023.8416100.0000AID485290
Chain A, Putative fructose-1,6-bisphosphate aldolaseGiardia intestinalisPotency19.90540.140911.194039.8107AID2451
Chain A, HADH2 proteinHomo sapiens (human)Potency12.62240.025120.237639.8107AID886; AID893
Chain B, HADH2 proteinHomo sapiens (human)Potency12.62240.025120.237639.8107AID886; AID893
Chain A, 2-oxoglutarate OxygenaseHomo sapiens (human)Potency12.58930.177814.390939.8107AID2147
Chain A, ATP-DEPENDENT DNA HELICASE Q1Homo sapiens (human)Potency39.81070.125919.1169125.8920AID2549
acetylcholinesteraseHomo sapiens (human)Potency50.50190.002541.796015,848.9004AID1347395; AID1347397; AID1347398; AID1347399
15-lipoxygenase, partialHomo sapiens (human)Potency0.10000.012610.691788.5700AID887
phosphopantetheinyl transferaseBacillus subtilisPotency4.00750.141337.9142100.0000AID1490
RAR-related orphan receptor gammaMus musculus (house mouse)Potency10.59090.006038.004119,952.5996AID1159521
USP1 protein, partialHomo sapiens (human)Potency79.43280.031637.5844354.8130AID504865
TDP1 proteinHomo sapiens (human)Potency21.27480.000811.382244.6684AID686978; AID686979
GLI family zinc finger 3Homo sapiens (human)Potency11.80680.000714.592883.7951AID1259369; AID1259392
Microtubule-associated protein tauHomo sapiens (human)Potency2.66510.180013.557439.8107AID1460; AID1468
AR proteinHomo sapiens (human)Potency36.93210.000221.22318,912.5098AID588516; AID743035; AID743063
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency33.99720.011212.4002100.0000AID1030
hypothetical protein, conservedTrypanosoma bruceiPotency12.58930.223911.245135.4813AID624173
EWS/FLI fusion proteinHomo sapiens (human)Potency11.74520.001310.157742.8575AID1259253; AID1259256
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency26.83250.000214.376460.0339AID720692
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency27.89390.003041.611522,387.1992AID1159553
retinoid X nuclear receptor alphaHomo sapiens (human)Potency44.66840.000817.505159.3239AID588544
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency30.61950.001530.607315,848.9004AID1224841; AID1224848; AID1224849; AID1259401; AID1259403
estrogen nuclear receptor alphaHomo sapiens (human)Potency0.07560.000229.305416,493.5996AID743075
GVesicular stomatitis virusPotency19.49710.01238.964839.8107AID1645842
cytochrome P450 2D6Homo sapiens (human)Potency10.96400.00108.379861.1304AID1645840
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency1.41250.035520.977089.1251AID504332
thyroid stimulating hormone receptorHomo sapiens (human)Potency33.88080.001628.015177.1139AID1224843; AID1224895; AID1259385; AID1259395
activating transcription factor 6Homo sapiens (human)Potency62.13540.143427.612159.8106AID1159516
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency14.08480.057821.109761.2679AID1159526; AID1159528
Histone H2A.xCricetulus griseus (Chinese hamster)Potency44.95910.039147.5451146.8240AID1224845; AID1224896
Caspase-7Cricetulus griseus (Chinese hamster)Potency17.46430.006723.496068.5896AID1346980
15-hydroxyprostaglandin dehydrogenase [NAD(+)] isoform 1Homo sapiens (human)Potency2.23870.001815.663839.8107AID894
vitamin D3 receptor isoform VDRAHomo sapiens (human)Potency11.22020.354828.065989.1251AID504847
caspase-3Cricetulus griseus (Chinese hamster)Potency17.46430.006723.496068.5896AID1346980
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency36.85060.000323.4451159.6830AID743065; AID743067
heat shock protein beta-1Homo sapiens (human)Potency37.57510.042027.378961.6448AID743210
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency34.81220.000627.21521,122.0200AID651741; AID743202; AID743219
lethal factor (plasmid)Bacillus anthracis str. A2012Potency25.11890.020010.786931.6228AID912
Interferon betaHomo sapiens (human)Potency19.49710.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency19.49710.01238.964839.8107AID1645842
Cellular tumor antigen p53Homo sapiens (human)Potency10.59300.002319.595674.0614AID651631
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency19.49710.01238.964839.8107AID1645842
ATPase family AAA domain-containing protein 5Homo sapiens (human)Potency26.60320.011917.942071.5630AID651632
Ataxin-2Homo sapiens (human)Potency26.60320.011912.222168.7989AID651632
cytochrome P450 2C9, partialHomo sapiens (human)Potency19.49710.01238.964839.8107AID1645842
ATP-dependent phosphofructokinaseTrypanosoma brucei brucei TREU927Potency4.46680.060110.745337.9330AID492961
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency28.18380.003245.467312,589.2998AID1705; AID2517
Chain A, TYROSYL-DNA PHOSPHODIESTERASEHomo sapiens (human)Potency7.07950.004023.8416100.0000AID485290
Chain A, HADH2 proteinHomo sapiens (human)Potency12.75850.025120.237639.8107AID886; AID893
Chain B, HADH2 proteinHomo sapiens (human)Potency12.75850.025120.237639.8107AID886; AID893
Chain A, 2-oxoglutarate OxygenaseHomo sapiens (human)Potency12.58930.177814.390939.8107AID2147
Chain A, ATP-DEPENDENT DNA HELICASE Q1Homo sapiens (human)Potency25.11890.125919.1169125.8920AID2549
endonuclease IVEscherichia coliPotency1.41250.707912.432431.6228AID1708
thioredoxin reductaseRattus norvegicus (Norway rat)Potency0.50340.100020.879379.4328AID488773; AID588453; AID588456
RGS12Homo sapiens (human)Potency1.99530.794310.991425.1189AID879
15-lipoxygenase, partialHomo sapiens (human)Potency0.79430.012610.691788.5700AID887
USP1 protein, partialHomo sapiens (human)Potency31.62280.031637.5844354.8130AID504865
GLS proteinHomo sapiens (human)Potency35.48130.35487.935539.8107AID624146
TDP1 proteinHomo sapiens (human)Potency18.25630.000811.382244.6684AID686978; AID686979
Microtubule-associated protein tauHomo sapiens (human)Potency7.94330.180013.557439.8107AID1460; AID1468
ThrombopoietinHomo sapiens (human)Potency12.58930.02517.304831.6228AID917; AID918
DNA polymerase III, partialBacillus subtilisPotency18.88761.062114.152826.6795AID485295
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency15.84890.011212.4002100.0000AID1030
hypothetical protein, conservedTrypanosoma bruceiPotency1.90120.223911.245135.4813AID624147
regulator of G-protein signaling 4Homo sapiens (human)Potency1.50030.531815.435837.6858AID504845
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency0.38230.035520.977089.1251AID504332
Bloom syndrome protein isoform 1Homo sapiens (human)Potency28.18380.540617.639296.1227AID2364; AID2528
cytochrome P450 2D6 isoform 1Homo sapiens (human)Potency39.81070.00207.533739.8107AID891
hexokinase-4 isoform 1Homo sapiens (human)Potency31.62282.511913.800328.1838AID743207
peripheral myelin protein 22 isoform 1Homo sapiens (human)Potency84.921423.934123.934123.9341AID1967
cytochrome P450 2C19 precursorHomo sapiens (human)Potency12.58930.00255.840031.6228AID899
cytochrome P450 2C9 precursorHomo sapiens (human)Potency3.16230.00636.904339.8107AID883
15-hydroxyprostaglandin dehydrogenase [NAD(+)] isoform 1Homo sapiens (human)Potency10.00000.001815.663839.8107AID894
vitamin D3 receptor isoform VDRAHomo sapiens (human)Potency15.84890.354828.065989.1251AID504847
chromobox protein homolog 1Homo sapiens (human)Potency8.91250.006026.168889.1251AID488953
glucokinase regulatory proteinHomo sapiens (human)Potency31.62282.511913.800328.1838AID743207
guanine nucleotide-binding protein G(i) subunit alpha-1 isoform 1Homo sapiens (human)Potency1.99530.794312.126325.1189AID879
mitogen-activated protein kinase 1Homo sapiens (human)Potency25.11890.039816.784239.8107AID995
flap endonuclease 1Homo sapiens (human)Potency36.01920.133725.412989.1251AID488816; AID588795
histone-lysine N-methyltransferase 2A isoform 2 precursorHomo sapiens (human)Potency50.11870.010323.856763.0957AID2662
peptidyl-prolyl cis-trans isomerase NIMA-interacting 1Homo sapiens (human)Potency26.85450.425612.059128.1838AID504536
DNA polymerase iota isoform a (long)Homo sapiens (human)Potency57.12200.050127.073689.1251AID588590
DNA polymerase kappa isoform 1Homo sapiens (human)Potency63.40540.031622.3146100.0000AID588579
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency39.81070.031610.279239.8107AID884; AID885
M-phase phosphoprotein 8Homo sapiens (human)Potency2.61580.177824.735279.4328AID488949
histone acetyltransferase KAT2A isoform 1Homo sapiens (human)Potency19.95260.251215.843239.8107AID504327
muscarinic acetylcholine receptor M1Rattus norvegicus (Norway rat)Potency0.14130.00106.000935.4813AID943
neuropeptide S receptor isoform AHomo sapiens (human)Potency25.11890.015812.3113615.5000AID1461
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Histamine H2 receptorCavia porcellus (domestic guinea pig)Potency3.16230.00638.235039.8107AID883
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
GABA theta subunitRattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency39.81071.000012.224831.6228AID885
phosphoglycerate kinaseTrypanosoma brucei brucei TREU927Potency26.85450.07578.474229.0628AID504547
ATP-dependent phosphofructokinaseTrypanosoma brucei brucei TREU927Potency3.79330.060110.745337.9330AID485368
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (258)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
cell population proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of B cell proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
nuclear DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
signal transduction in response to DNA damageATPase family AAA domain-containing protein 5Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
isotype switchingATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of isotype switching to IgG isotypesATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloadingATPase family AAA domain-containing protein 5Homo sapiens (human)
regulation of mitotic cell cycle phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of cell cycle G2/M phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
cognitionAmyloid-beta precursor proteinHomo sapiens (human)
G2/M transition of mitotic cell cycleAmyloid-beta precursor proteinHomo sapiens (human)
microglial cell activationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of protein phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
suckling behaviorAmyloid-beta precursor proteinHomo sapiens (human)
astrocyte activation involved in immune responseAmyloid-beta precursor proteinHomo sapiens (human)
regulation of translationAmyloid-beta precursor proteinHomo sapiens (human)
protein phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
intracellular copper ion homeostasisAmyloid-beta precursor proteinHomo sapiens (human)
endocytosisAmyloid-beta precursor proteinHomo sapiens (human)
response to oxidative stressAmyloid-beta precursor proteinHomo sapiens (human)
cell adhesionAmyloid-beta precursor proteinHomo sapiens (human)
regulation of epidermal growth factor-activated receptor activityAmyloid-beta precursor proteinHomo sapiens (human)
Notch signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
axonogenesisAmyloid-beta precursor proteinHomo sapiens (human)
learning or memoryAmyloid-beta precursor proteinHomo sapiens (human)
learningAmyloid-beta precursor proteinHomo sapiens (human)
mating behaviorAmyloid-beta precursor proteinHomo sapiens (human)
locomotory behaviorAmyloid-beta precursor proteinHomo sapiens (human)
axo-dendritic transportAmyloid-beta precursor proteinHomo sapiens (human)
cholesterol metabolic processAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of cell population proliferationAmyloid-beta precursor proteinHomo sapiens (human)
adult locomotory behaviorAmyloid-beta precursor proteinHomo sapiens (human)
visual learningAmyloid-beta precursor proteinHomo sapiens (human)
regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of peptidyl-threonine phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of G2/M transition of mitotic cell cycleAmyloid-beta precursor proteinHomo sapiens (human)
microglia developmentAmyloid-beta precursor proteinHomo sapiens (human)
axon midline choice point recognitionAmyloid-beta precursor proteinHomo sapiens (human)
neuron remodelingAmyloid-beta precursor proteinHomo sapiens (human)
dendrite developmentAmyloid-beta precursor proteinHomo sapiens (human)
regulation of Wnt signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
extracellular matrix organizationAmyloid-beta precursor proteinHomo sapiens (human)
forebrain developmentAmyloid-beta precursor proteinHomo sapiens (human)
neuron projection developmentAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of chemokine productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of interleukin-1 beta productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of interleukin-6 productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of tumor necrosis factor productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
ionotropic glutamate receptor signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
regulation of multicellular organism growthAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of neuron differentiationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of glycolytic processAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of mitotic cell cycleAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of JNK cascadeAmyloid-beta precursor proteinHomo sapiens (human)
astrocyte activationAmyloid-beta precursor proteinHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityAmyloid-beta precursor proteinHomo sapiens (human)
collateral sprouting in absence of injuryAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of inflammatory responseAmyloid-beta precursor proteinHomo sapiens (human)
regulation of peptidyl-tyrosine phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
regulation of synapse structure or activityAmyloid-beta precursor proteinHomo sapiens (human)
synapse organizationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of calcium-mediated signalingAmyloid-beta precursor proteinHomo sapiens (human)
neuromuscular process controlling balanceAmyloid-beta precursor proteinHomo sapiens (human)
synaptic assembly at neuromuscular junctionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of protein metabolic processAmyloid-beta precursor proteinHomo sapiens (human)
neuron apoptotic processAmyloid-beta precursor proteinHomo sapiens (human)
smooth endoplasmic reticulum calcium ion homeostasisAmyloid-beta precursor proteinHomo sapiens (human)
neuron cellular homeostasisAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeAmyloid-beta precursor proteinHomo sapiens (human)
response to interleukin-1Amyloid-beta precursor proteinHomo sapiens (human)
modulation of excitatory postsynaptic potentialAmyloid-beta precursor proteinHomo sapiens (human)
NMDA selective glutamate receptor signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
regulation of spontaneous synaptic transmissionAmyloid-beta precursor proteinHomo sapiens (human)
cytosolic mRNA polyadenylationAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of long-term synaptic potentiationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of long-term synaptic potentiationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of non-canonical NF-kappaB signal transductionAmyloid-beta precursor proteinHomo sapiens (human)
cellular response to amyloid-betaAmyloid-beta precursor proteinHomo sapiens (human)
regulation of presynapse assemblyAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of amyloid fibril formationAmyloid-beta precursor proteinHomo sapiens (human)
amyloid fibril formationAmyloid-beta precursor proteinHomo sapiens (human)
neuron projection maintenanceAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of T cell migrationAmyloid-beta precursor proteinHomo sapiens (human)
central nervous system developmentAmyloid-beta precursor proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (62)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP hydrolysis activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloader activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingAmyloid-beta precursor proteinHomo sapiens (human)
DNA bindingAmyloid-beta precursor proteinHomo sapiens (human)
serine-type endopeptidase inhibitor activityAmyloid-beta precursor proteinHomo sapiens (human)
signaling receptor bindingAmyloid-beta precursor proteinHomo sapiens (human)
protein bindingAmyloid-beta precursor proteinHomo sapiens (human)
heparin bindingAmyloid-beta precursor proteinHomo sapiens (human)
enzyme bindingAmyloid-beta precursor proteinHomo sapiens (human)
identical protein bindingAmyloid-beta precursor proteinHomo sapiens (human)
transition metal ion bindingAmyloid-beta precursor proteinHomo sapiens (human)
receptor ligand activityAmyloid-beta precursor proteinHomo sapiens (human)
PTB domain bindingAmyloid-beta precursor proteinHomo sapiens (human)
protein serine/threonine kinase bindingAmyloid-beta precursor proteinHomo sapiens (human)
signaling receptor activator activityAmyloid-beta precursor proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (71)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
Elg1 RFC-like complexATPase family AAA domain-containing protein 5Homo sapiens (human)
nucleusATPase family AAA domain-containing protein 5Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
extracellular spaceAmyloid-beta precursor proteinHomo sapiens (human)
dendriteAmyloid-beta precursor proteinHomo sapiens (human)
extracellular regionAmyloid-beta precursor proteinHomo sapiens (human)
extracellular spaceAmyloid-beta precursor proteinHomo sapiens (human)
nuclear envelope lumenAmyloid-beta precursor proteinHomo sapiens (human)
cytoplasmAmyloid-beta precursor proteinHomo sapiens (human)
mitochondrial inner membraneAmyloid-beta precursor proteinHomo sapiens (human)
endosomeAmyloid-beta precursor proteinHomo sapiens (human)
early endosomeAmyloid-beta precursor proteinHomo sapiens (human)
endoplasmic reticulumAmyloid-beta precursor proteinHomo sapiens (human)
endoplasmic reticulum lumenAmyloid-beta precursor proteinHomo sapiens (human)
smooth endoplasmic reticulumAmyloid-beta precursor proteinHomo sapiens (human)
Golgi apparatusAmyloid-beta precursor proteinHomo sapiens (human)
Golgi lumenAmyloid-beta precursor proteinHomo sapiens (human)
Golgi-associated vesicleAmyloid-beta precursor proteinHomo sapiens (human)
cytosolAmyloid-beta precursor proteinHomo sapiens (human)
plasma membraneAmyloid-beta precursor proteinHomo sapiens (human)
clathrin-coated pitAmyloid-beta precursor proteinHomo sapiens (human)
cell-cell junctionAmyloid-beta precursor proteinHomo sapiens (human)
synaptic vesicleAmyloid-beta precursor proteinHomo sapiens (human)
cell surfaceAmyloid-beta precursor proteinHomo sapiens (human)
membraneAmyloid-beta precursor proteinHomo sapiens (human)
COPII-coated ER to Golgi transport vesicleAmyloid-beta precursor proteinHomo sapiens (human)
axonAmyloid-beta precursor proteinHomo sapiens (human)
growth coneAmyloid-beta precursor proteinHomo sapiens (human)
platelet alpha granule lumenAmyloid-beta precursor proteinHomo sapiens (human)
neuromuscular junctionAmyloid-beta precursor proteinHomo sapiens (human)
endosome lumenAmyloid-beta precursor proteinHomo sapiens (human)
trans-Golgi network membraneAmyloid-beta precursor proteinHomo sapiens (human)
ciliary rootletAmyloid-beta precursor proteinHomo sapiens (human)
dendritic spineAmyloid-beta precursor proteinHomo sapiens (human)
dendritic shaftAmyloid-beta precursor proteinHomo sapiens (human)
perikaryonAmyloid-beta precursor proteinHomo sapiens (human)
membrane raftAmyloid-beta precursor proteinHomo sapiens (human)
apical part of cellAmyloid-beta precursor proteinHomo sapiens (human)
synapseAmyloid-beta precursor proteinHomo sapiens (human)
perinuclear region of cytoplasmAmyloid-beta precursor proteinHomo sapiens (human)
presynaptic active zoneAmyloid-beta precursor proteinHomo sapiens (human)
spindle midzoneAmyloid-beta precursor proteinHomo sapiens (human)
recycling endosomeAmyloid-beta precursor proteinHomo sapiens (human)
extracellular exosomeAmyloid-beta precursor proteinHomo sapiens (human)
receptor complexAmyloid-beta precursor proteinHomo sapiens (human)
early endosomeAmyloid-beta precursor proteinHomo sapiens (human)
membrane raftAmyloid-beta precursor proteinHomo sapiens (human)
cell surfaceAmyloid-beta precursor proteinHomo sapiens (human)
Golgi apparatusAmyloid-beta precursor proteinHomo sapiens (human)
plasma membraneAmyloid-beta precursor proteinHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (54)

Assay IDTitleYearJournalArticle
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID686947qHTS for small molecule inhibitors of Yes1 kinase: Primary Screen2013Bioorganic & medicinal chemistry letters, Aug-01, Volume: 23, Issue:15
Identification of potent Yes1 kinase inhibitors using a library screening approach.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (16)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (6.25)29.6817
2010's9 (56.25)24.3611
2020's6 (37.50)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 89.41

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index89.41 (24.57)
Research Supply Index2.40 (2.92)
Research Growth Index4.55 (4.65)
Search Engine Demand Index153.55 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (89.41)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Trials0 (0.00%)5.53%
Reviews0 (0.00%)6.00%
Reviews0 (0.00%)6.00%
Case Studies0 (0.00%)4.05%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Observational0 (0.00%)0.25%
Other10 (100.00%)84.16%
Other11 (100.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (1133)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel and Cisplatin or Oxaliplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma [NCT00253370]Phase 244 participants (Actual)Interventional2005-10-31Completed
A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer [NCT01495676]69 participants (Actual)Interventional2011-07-06Active, not recruiting
Randomized Phase II/III Trial of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck [NCT01810913]Phase 2/Phase 3613 participants (Anticipated)Interventional2013-03-22Recruiting
Open-label, Phase 2 Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metast [NCT05849246]Phase 2130 participants (Anticipated)Interventional2023-05-30Not yet recruiting
Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol - The PIPAC-OPC2 Trial [NCT03287375]Phase 2143 participants (Actual)Interventional2016-12-01Completed
A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304) [NCT04700124]Phase 3784 participants (Anticipated)Interventional2021-04-21Active, not recruiting
Prospective Non-inferior Clinical Trial Comparing Concurrent Chemoradiotherapy or Radiotherapy Alone in Patients With Intermediate Risk Nasopharyngeal Carcinoma in Intensity-modulated Radiotherapy Era [NCT02289807]0 participants (Actual)Interventional2015-03-31Withdrawn
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas [NCT00047008]Phase 3743 participants (Actual)Interventional2002-07-31Completed
Phase II Trial of Cisplatin Combined With Oral TS-1 in Patients With Advanced Solid Tumors With Different Degrees of Liver Dysfunction [NCT03519074]Phase 248 participants (Anticipated)Interventional2016-07-22Recruiting
A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary Lung Cancer or Lung Metastases [NCT01114958]Phase 18 participants (Actual)Interventional2009-09-03Completed
A Retrospective Study of Extremity Osteosarcoma Patients Who Recieved Intra-arterial Limb Infusion of Cisplatin During Neoadjuvant Chemotherapy [NCT03909776]99 participants (Actual)Interventional2019-01-01Completed
Randomized Phase II Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer [NCT01283204]Phase 2180 participants (Actual)Interventional2010-03-09Completed
A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy [NCT02422498]Phase 249 participants (Actual)Interventional2015-04-14Completed
A Phase II, Multicenter, Randomized,Two-Arm Clinical Study: An Investigational Arm Containing Nimotuzumab in Combination With Radiotion Therapy and Cisplatyn, and a Control Arm With Radiation Therapy and Cisplatin for the Definitive Treatment of Stage IB [NCT01301612]Phase 20 participants (Actual)Interventional2011-01-31Withdrawn(stopped due to Regulatory requirement. A phase III study is being designed.)
Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study [NCT00274937]Phase 3111 participants (Actual)Interventional2006-02-20Completed
Panitumumab in Combination With Cisplatin/Gemcitabine Chemotherapy in Patients With Cholangiocarcinomas - a Randomized Clinical Phase II Study [NCT01320254]Phase 293 participants (Actual)Interventional2011-06-30Completed
An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC) [NCT06157827]Phase 1/Phase 268 participants (Anticipated)Interventional2023-12-05Not yet recruiting
A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC) [NCT06064097]Phase 250 participants (Anticipated)Interventional2023-12-20Not yet recruiting
Phase II Study of Bladder-SparIng ChemoradiatioN With Durvalumab in Clinical Stage III, Node PosItive BladdeR CancEr (INSPIRE) [NCT04216290]Phase 295 participants (Anticipated)Interventional2021-03-17Active, not recruiting
Randomized Phase III Trial of MEDI4736 (Durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC [NCT04092283]Phase 3660 participants (Anticipated)Interventional2020-04-29Active, not recruiting
Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) Alone or in Combination With Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC) [NCT03382561]Phase 2160 participants (Actual)Interventional2018-05-02Active, not recruiting
Phase II Randomized Placebo-Controlled Trial of Cisplatin With or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer, With or Without Brain Metastases [NCT02595905]Phase 2333 participants (Anticipated)Interventional2016-09-15Active, not recruiting
Phase I Dose-Escalation Bioavailability Study of Oral Triapine in Combination With Concurrent Chemoradiation for Locally Advanced Cervical Cancer (LACC) and Vaginal Cancer [NCT02595879]Phase 122 participants (Actual)Interventional2019-09-18Active, not recruiting
A Phase I/Randomized Phase II Study of Cediranib (NSC#732208) Versus Placebo in Combination With Cisplatin and Pemetrexed in Chemonaive Patients With Malignant Pleural Mesothelioma [NCT01064648]Phase 1/Phase 2117 participants (Actual)Interventional2010-03-15Active, not recruiting
A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer [NCT00588770]Phase 3403 participants (Actual)Interventional2008-08-08Active, not recruiting
A Feasibility Study of Vorinostat (SAHA) Combined With Isotretinoin and Chemotherapy in Infants With Embryonal Tumors of the Central Nervous System [NCT00867178]Phase 133 participants (Actual)Interventional2009-02-25Completed
Multiinstitutional Open Label Randomized Phase II Study Comparing Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy as Firstline Treatment for Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-NHSCC) [NCT01216020]Phase 270 participants (Actual)Interventional2010-10-31Terminated(stopped due to insufficient recruitment)
Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer [NCT01375972]Phase 292 participants (Actual)Interventional2008-03-31Completed
A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer [NCT01230996]Phase 1/Phase 222 participants (Actual)Interventional2010-07-31Completed
A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma [NCT05213884]Phase 230 participants (Anticipated)Interventional2022-01-01Recruiting
Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination With Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer [NCT01642251]Phase 1/Phase 2156 participants (Actual)Interventional2012-09-28Completed
Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer [NCT03366766]Phase 214 participants (Actual)Interventional2017-12-20Completed
A Randomized, Multicenter, Phase II Trial of Cisplatin, Irinotecan and Bevacizumab (PCA) vs. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer [NCT00911820]Phase 288 participants (Actual)Interventional2009-07-31Completed
A Single Institutional Phase II Clinical Trial of Abraxane Combined With Cisplatin in Metastatic Breast Cancer [NCT01149798]Phase 273 participants (Actual)Interventional2010-06-30Completed
Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial [NCT05941741]Phase 3380 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma [NCT05834543]Phase 1/Phase 275 participants (Anticipated)Interventional2023-05-31Not yet recruiting
Randomized Phase II Study of Induction Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy (WBRT) Versus WBRT Alone in Breast Cancer With Untreated Brain Metastases [NCT02185352]Phase 2120 participants (Actual)Interventional2014-04-21Active, not recruiting
A Limited Access Phase I Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888 (Veliparib) (NSC#737664) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix [NCT01281852]Phase 137 participants (Actual)Interventional2011-03-14Completed
A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma [NCT01286766]Phase 26 participants (Actual)Interventional2009-09-30Completed
INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN. [NCT01285674]20 participants (Anticipated)Interventional2011-01-31Not yet recruiting
Multicenter, Randomized, Double-blind, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of TQB2450 Plus Chemotherapy(Cisplatin or Carboplatin+ 5-Fluorouracil (5-FU) ) Versus Placebo Plus Chemotherapy as First-Line Treatment in Patients With Recu [NCT03855384]Phase 3334 participants (Anticipated)Interventional2019-06-11Recruiting
A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma [NCT01187238]Phase 284 participants (Actual)Interventional2010-05-31Completed
A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-aortic Lymph Nodes [NCT01295502]Phase 145 participants (Anticipated)Interventional2011-04-04Active, not recruiting
A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) [NCT01383148]Phase 2/Phase 3222 participants (Actual)Interventional2012-04-30Terminated
A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer [NCT01198392]Phase 3270 participants (Anticipated)Interventional2008-09-30Recruiting
A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy [NCT01297998]Phase 124 participants (Actual)Interventional2011-01-31Completed
Phase II Study of Patients With Peritoneal Carcinomatosis From Gastric Cancer Treated With Preoperative Systemic Chemotherapy Followed by Peritonectomy and Intraperitoneal Chemotherapy [NCT01379482]Phase 218 participants (Actual)Interventional2005-01-31Completed
A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma [NCT03822897]Phase 2103 participants (Actual)Interventional2019-06-28Active, not recruiting
A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix [NCT00064077]Phase 3513 participants (Actual)Interventional2003-05-31Completed
Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients With Stage III &Amp; IV or Recurrent Endometrial Cancer [NCT00063999]Phase 31,381 participants (Actual)Interventional2003-08-25Completed
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma [NCT01327521]Phase 30 participants (Actual)Interventional2011-02-28Withdrawn(stopped due to Accrual below target levels)
Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance [NCT03927495]Phase 2100 participants (Anticipated)Interventional2019-05-22Recruiting
Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations [NCT01131429]Phase 260 participants (Anticipated)Interventional2010-06-30Not yet recruiting
A Three-Arm Phase III Study of Concomitant Versus Sequential Chemotherapy and Thoracic Radiotherapy for Patients With Locally Advanced Inoperable Non-small Cell Lung Cancer [NCT01134861]Phase 3610 participants (Actual)Interventional1994-07-31Completed
A Phase II Study of Induction Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A) in Patients With Locally Advanced Head and Neck Cancer (CTRC# 11-36) [NCT01588431]Phase 25 participants (Actual)Interventional2011-12-31Active, not recruiting
A Phase I Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer [NCT01269255]Phase 16 participants (Actual)Interventional2009-12-31Completed
A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0) [NCT01283217]Phase 3166 participants (Anticipated)Interventional2010-03-31Recruiting
Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients [NCT02036164]Phase 3500 participants (Anticipated)Interventional2014-01-31Recruiting
Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigator's Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy [NCT06008106]Phase 3165 participants (Anticipated)Interventional2023-09-22Not yet recruiting
Phase II Randomized Controlled Trial of Accelerated Fractionation Radiotherapy (6 Fractions Per Week) Versus Concurrent Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma [NCT01291095]Phase 280 participants (Anticipated)Interventional2011-02-28Recruiting
A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Sm [NCT03976323]Phase 31,005 participants (Actual)Interventional2019-06-28Active, not recruiting
Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy [NCT03772028]Phase 3538 participants (Anticipated)Interventional2020-01-01Recruiting
A Phase 1b/2 Study of PEP503 (Radioenhancer) With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer [NCT02901483]Phase 1/Phase 212 participants (Actual)Interventional2016-10-11Terminated(stopped due to bussiness reason)
Study of Pd-1 Antibody in Combination With Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer [NCT04516616]Phase 282 participants (Anticipated)Interventional2020-12-01Recruiting
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes and Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma [NCT02421640]Phase 2116 participants (Anticipated)Interventional2015-03-31Recruiting
Induction Chemotherapy and Toripalimab Followed by Surgery or Radiotherapy for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma [NCT04995120]Phase 242 participants (Anticipated)Interventional2021-04-07Recruiting
Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck [NCT01360827]Phase 113 participants (Actual)Interventional2010-08-31Terminated(stopped due to Study terminated due to potential safety concerns in combination with platinum-based therapies)
Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer. [NCT02407912]50 participants (Anticipated)Interventional2015-03-31Recruiting
Neoadjuvant Low-dose Radiotherapy, Tislelizumab, Combined With Albumin-bound Paclitaxel and Cisplatin in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (NeoRTPC02): an Open Label, Single-arm, Phase II Clinical Trial [NCT05343325]Phase 225 participants (Anticipated)Interventional2022-03-09Recruiting
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) [NCT02072148]112 participants (Actual)Interventional2014-03-31Completed
Official Title: A Phase II Multicenter, Open Label, Non-randomized Study of Neoadjuvant and Adjuvant Treatment With IPH5201 and Durvalumab in Patients With Resectable, Early-stage (II to IIIA) Non-Small Cell Lung Cancer (MATISSE) [NCT05742607]Phase 270 participants (Anticipated)Interventional2023-06-23Recruiting
GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Newly Diagnosed Stage III a [NCT05659381]Phase 3230 participants (Anticipated)Interventional2023-12-11Not yet recruiting
Phase I/Ib Study of AKT Inhibitor Ipatasertib With Chemoradiation for Locally Advanced Head and Neck Cancer [NCT05172245]Phase 146 participants (Anticipated)Interventional2022-09-19Recruiting
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Using Cisplatin, Mitomycin, and Adriamycin in Peritoneal Surface Malignancies Also Known as Hyperthermic Intraperitoneal Chemotherapy. [NCT02349958]Phase 2200 participants (Anticipated)Interventional2006-09-30Recruiting
A Phase Ib Study of BKM120 With Weekly Cisplatin and Radiotherapy in High Risk Locally Advanced Squamous Cell Cancer of the Head and Neck [NCT02113878]Phase 123 participants (Actual)Interventional2014-09-29Completed
Phase III Randomized Non-inferiority Trial of Reduced-dose Versus Standard Dose Radiotherapy for Stage II-III Nasopharyngeal Carcinoma Which Have Favorable Response After Induction Chemotherapy [NCT05304468]Phase 3380 participants (Anticipated)Interventional2022-03-29Recruiting
InterAACT - An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin Plus 5-Fluorouracil Versus Carboplatin Plus Weekly Paclitaxel in Patients With Inoperable Locally Recurrent or Metastatic Disease [NCT02560298]Phase 291 participants (Actual)Interventional2016-08-23Active, not recruiting
Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study [NCT03797625]Phase 276 participants (Anticipated)Interventional2017-05-04Recruiting
A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy [NCT03781869]Phase 2116 participants (Anticipated)Interventional2018-12-31Not yet recruiting
Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer [NCT03769935]Phase 290 participants (Actual)Interventional2017-01-01Completed
Randomized Trial of Comparing One Cycle With Three Cycles Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Locoregionally Advanced Nasopharyngeal Carcinoma [NCT02096380]120 participants (Anticipated)Observational [Patient Registry]2014-05-31Not yet recruiting
Phase III Randomized Trial of Pleurectomy/Decortication Plus Systemic Therapy With or Without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma (MPM) [NCT04158141]Phase 316 participants (Actual)Interventional2020-01-29Terminated(stopped due to Permanent Administrative Closure)
Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently With Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer [NCT03738228]Phase 140 participants (Actual)Interventional2019-01-07Active, not recruiting
A Phase I Study of the Wee 1 Kinase (Wee 1) Inhibitor AZD1775 in Combination With Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735) [NCT03345784]Phase 110 participants (Actual)Interventional2018-05-29Active, not recruiting
Phase I/II Study of Brentuximab Vedotin and Methotrexate/ L-asparaginase/ Dexamethasone (B-MAD) Chemotherapy in Patients With Newly-diagnosed Extranodal NK/ T-cell Lymphoma [NCT03246750]Phase 1/Phase 234 participants (Actual)Interventional2019-01-30Active, not recruiting
A Pilot Study: Phase II Study of Histology-based Consolidation Chemotherapy Following Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer [NCT01336543]Phase 20 participants (Actual)Interventional2011-03-31Withdrawn(stopped due to Low accrual, small patient population at center.)
A Prospective Phase II Study of Involved Field Elective Volume De-Intensification for Oropharyngeal and Laryngeal Squamous Cell Carcinoma Treated With Intensity Modulated Radiation Therapy [NCT03067610]Phase 272 participants (Actual)Interventional2017-01-20Completed
A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer [NCT01348009]Phase 1/Phase 263 participants (Anticipated)Interventional2011-05-31Recruiting
Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients [NCT00392327]Phase 3379 participants (Actual)Interventional2007-03-26Active, not recruiting
Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial [NCT01372111]Phase 276 participants (Anticipated)Interventional2011-03-31Active, not recruiting
Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury [NCT02250872]Phase 2/Phase 3182 participants (Anticipated)Interventional2014-12-31Recruiting
The Efficacy and Safety of Anlotinib Plus TQB2450 Combined With Nab-paclitaxel and Cisplatin as First-line Treatment for Advanced Biliary Tract Cancer [NCT05812430]Phase 220 participants (Anticipated)Interventional2023-04-10Recruiting
A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology [NCT02891447]Phase 224 participants (Actual)Interventional2016-09-01Completed
Recombinant Human Endostatin in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer With Negative Driver Gene: a Multicenter, Single-Arm Trial [NCT05574998]Phase 2100 participants (Anticipated)Interventional2021-02-01Recruiting
Toripalimab Plus Etoposide and Platinum-based Chemotherapy in First-line Treatment of Locally Advanced or Metastatic Genitourinary Small Cell Carcinoma:A Multicenter, Prospective, Open Label, Single-arm, Phase II Study [NCT05760053]Phase 233 participants (Anticipated)Interventional2023-02-18Recruiting
EGFR Tyrosine Kinase Inhibitor Combined With Concurrent or Sequential Chemotherapy for Advanced Lung Cancer Patients of Gradual Progression After First-line EGFR-TKI Therapy: a Randomized Controlled Study [NCT03544814]Phase 299 participants (Actual)Interventional2015-01-01Completed
LCI-LUN-NSC-SBRT-001: Phase II Prospective Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation and Adjuvant Immunotherapy for Locally-Advanced Non-Small Cell Lung Cancer [NCT03141359]Phase 261 participants (Actual)Interventional2017-05-12Active, not recruiting
Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurren [NCT00101582]Phase 3188 participants (Actual)Interventional2005-08-31Completed
Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer [NCT02182778]Phase 3246 participants (Actual)Interventional2014-07-09Completed
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Can [NCT02542293]Phase 3953 participants (Actual)Interventional2015-11-03Active, not recruiting
A Phase I Dose Escalation Study of MK1775 in Monotherapy, in Combination With 5-Fluorouracil, and in Combination With 5-Fluorouracil and Cisplatin in Patients With Advanced Solid Tumor [NCT01047007]Phase 111 participants (Actual)Interventional2010-01-18Terminated(stopped due to The study has been terminated due to business reasons.)
A Randomized Phase II Study of Capecitabine and Cisplatin (XP) +/- Sorafenib (Nexavar®) in Patients With Advanced Gastric Cancer [NCT01187212]Phase 2195 participants (Actual)Interventional2010-08-31Completed
Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN) [NCT01301248]Phase 280 participants (Anticipated)Interventional2008-03-31Active, not recruiting
Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck [NCT00122460]Phase 3442 participants (Actual)Interventional2004-12-31Completed
A Pilot Study of Chemoradiotherapy Plus Temsirolimus (Torisel) for Advanced Head and Neck Cancer [NCT01326468]0 participants (Actual)Interventional2011-01-31Withdrawn(stopped due to funding)
A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva [NCT00068406]Phase 261 participants (Actual)Interventional2005-01-31Completed
A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer [NCT00394433]Phase 238 participants (Actual)Interventional2006-09-30Completed
Phase I/II Trial of Best Supportive Care and Chemotherapy, Either Cisplatin or Paclitaxel, in Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer Presenting With Inoperable Malignant Bowel Obstruction [NCT01083537]Phase 1/Phase 21 participants (Actual)Interventional2010-02-28Terminated(stopped due to Slow accrual)
Phase III Open Label First Line Therapy Study of Tislelizumab With Chemotherapy Versus Chemotherapy in Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer(NSCLC) [NCT03663205]Phase 3334 participants (Actual)Interventional2018-07-23Completed
Camrelizumab Combined With Induction Chemotherapy and Intensity Modulated Radiotherapy for the Treatment of Locally Advanced Nasopharyngeal Carcinoma:a Randomized, Multicenter, Phase II Trial [NCT05097209]Phase 2200 participants (Anticipated)Interventional2022-04-06Recruiting
A Phase 1, Single Arm Investigator-initiated Study to Investigate the Safety of Combining the Antibody Magrolimab With Standard First Line Platinum-based Chemotherapy (With Cisplatin / Gemcitabine) in Advanced Urothelial Carcinoma [NCT05738161]Phase 126 participants (Anticipated)Interventional2023-06-21Recruiting
A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head an [NCT04459715]Phase 3730 participants (Actual)Interventional2020-08-07Active, not recruiting
A Phase I, Multi-Center, Open Label, Dose De-Escalation and Expansion Study of Gemcitabine and Cisplatin With AG120 or Pemigatinib for Advanced Cholangiocarcinoma [NCT04088188]Phase 18 participants (Actual)Interventional2021-01-25Active, not recruiting
Phase II Trial of Standard Platinum Doublet Chemotherapy + Various Proton Beam Therapy (PBT) Doses in Order to Determine the Optimal Dose of PBT for Unresectable Stage 2/3 Non-Small Cell Lung Cancer [NCT03132532]Phase 218 participants (Actual)Interventional2017-07-31Active, not recruiting
Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer [NCT01504815]Phase 3268 participants (Actual)Interventional2012-03-31Active, not recruiting
Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial [NCT00003907]Phase 250 participants (Actual)Interventional1999-12-15Completed
Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer [NCT01097252]Phase 3104 participants (Actual)Interventional2002-01-31Completed
Tolerability of Laser-assisted Cisplatin + 5-fluorouracil- an Exploratory Proof of Concept Study of Topical Combination Chemotherapy for Basal Cell Carcinoma [NCT03541252]Phase 1/Phase 220 participants (Actual)Interventional2018-03-09Completed
A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20% [NCT03351842]Phase 2460 participants (Anticipated)Interventional2017-09-01Recruiting
Primary Surgery Vs Primary Chemoradiation for Oropharyngeal Cancer (Scope Trial) - A Phase II/III Integrated Design Randomized Control Trial [NCT05144100]Phase 2/Phase 3498 participants (Anticipated)Interventional2021-12-01Not yet recruiting
Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy [NCT02492360]0 participants (Actual)Observational2017-12-31Withdrawn(stopped due to Lack of funding)
Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma Phaseâ…¡Clinical Randomized Study [NCT02187315]Phase 2160 participants (Anticipated)Interventional2014-05-31Recruiting
Cadonilimab Combined With Induction Chemotherapy and Definitive Radiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: a Phase II, Single-arm Trial (EC-CRT-006) [NCT06143748]Phase 246 participants (Anticipated)Interventional2023-12-15Not yet recruiting
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study [NCT05857631]90 participants (Anticipated)Interventional2023-05-29Recruiting
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial [NCT04473716]Phase 120 participants (Actual)Interventional2020-07-30Completed
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN) [NCT03800134]Phase 3826 participants (Actual)Interventional2018-12-06Active, not recruiting
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years [NCT01096368]Phase 3479 participants (Actual)Interventional2010-05-07Active, not recruiting
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer [NCT00334815]Phase 229 participants (Actual)Interventional2006-06-15Active, not recruiting
Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer. [NCT00526396]Phase 3160 participants (Anticipated)Interventional2007-09-30Active, not recruiting
Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma [NCT01029873]Phase 1/Phase 225 participants (Actual)Interventional2010-02-28Completed
Four Cycles of Cisplatin-Based Chemotherapy in Metastatic Urothelial Carcinoma Compared to Six Cycles: Randomized Phase III Trial - FOCUS Study - [NCT03296306]Phase 3330 participants (Anticipated)Interventional2016-09-30Recruiting
Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous [NCT02280993]Phase 172 participants (Anticipated)Interventional2014-05-31Active, not recruiting
A Phase 1/2 Study of Apatinib in Combination With AP(Pemetrexed/Cisplatin) or AC(Pemetrexed/Carboplatin) as First-line Chemotherapy for Advanced Epidermal Growth Factor Receptor(EGFR) Wild Type Non-squamous Non-small Cell Lung Cancer [NCT03201146]Phase 1/Phase 248 participants (Anticipated)Interventional2017-06-27Recruiting
Phase I /II Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma [NCT02446574]Phase 1/Phase 233 participants (Actual)Interventional2007-07-31Completed
A Phase 1 Study of COTI-2 as Monotherapy or Combination Therapy for the Treatment of Advanced or Recurrent Malignancies [NCT02433626]Phase 151 participants (Anticipated)Interventional2015-12-31Recruiting
Phase â…¡ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis [NCT02291211]Phase 260 participants (Anticipated)Interventional2014-09-30Recruiting
Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer [NCT02435186]Phase 2100 participants (Anticipated)Interventional2015-06-30Not yet recruiting
Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study [NCT02429726]Phase 290 participants (Anticipated)Interventional2015-06-30Not yet recruiting
Non Randomized, Multicenter, Prospective Pediatric Hodgkin Lymphoma Treatment Trial Stratified According to Initial Risk Factors and Response to Chemotherapy, Reduced Cumulative Doses of Antineoplastic Agents and Radiotherapy. [NCT03500133]Phase 4500 participants (Anticipated)Interventional2017-10-06Recruiting
A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas [NCT04620187]Phase 255 participants (Anticipated)Interventional2020-12-24Recruiting
Cisplatin Combined With Irinotecan or Etoposide for Untreated Extensive-stage Small Cell Lung Cancer: a Multicenter Randomized Control Clinical Trial [NCT02323737]Phase 262 participants (Actual)Interventional2010-07-31Completed
Los Tres Paso Trial: Step One - Neoadjuvant Palbociclib Monotherapy, Step Two - Concurrent Chemoradiation Therapy, and Step Three - Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma [NCT03389477]Phase 226 participants (Actual)Interventional2018-04-27Active, not recruiting
Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients With Newly Diagnosed High-Risk Neuroblastoma [NCT01798004]Phase 1150 participants (Actual)Interventional2013-04-08Active, not recruiting
A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma [NCT01175356]Phase 199 participants (Actual)Interventional2010-10-04Active, not recruiting
Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study [NCT00453154]Phase 1/Phase 2156 participants (Actual)Interventional2007-03-15Completed
Phase II Multi-Center Study of Nab-paclitaxel, Gemcitabine and Cisplatin (NGC-Triple Regimen as Preoperative Therapy in Patients With Potentially Resectable and Borderline Resectable Pancreatic Cancer [NCT03392571]Phase 20 participants (Actual)Interventional2018-08-15Withdrawn(stopped due to Study was stopped due to lack of funding)
A Phase I Study of INCB024360 (Epacadostat) Alone, INCB024360 in Combination With Pembrolizumab (MK-3475), and INCB024360 and Pembrolizumab in Combination With Chemotherapy in Patients With Advanced Solid Tumors (KEYNOTE-434) [NCT02862457]Phase 134 participants (Actual)Interventional2016-08-23Completed
Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis (Liposomal Cisplatin Formulation) in Patients With Advanced or Refractory Tumours [NCT01861496]Phase 1/Phase 250 participants (Actual)Interventional2013-04-30Completed
Sequential Chemoradiotherapy With Reduced Target Delineation and Radiation Doses During Radiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03389295]Phase 2118 participants (Actual)Interventional2010-01-31Completed
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma : Randomized Clinical Trial. [NCT02328716]Phase 332 participants (Anticipated)Interventional2012-02-29Recruiting
A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selecti [NCT00777491]Phase 270 participants (Actual)Interventional2008-12-31Completed
A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide [NCT00057837]Phase 2140 participants (Actual)Interventional2004-07-14Completed
"Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx ENID" [NCT04444869]Phase 228 participants (Anticipated)Interventional2020-09-28Recruiting
Phase II Study of Preoperative TPF Chemotherapy in Locally Advanced Resectable Oral Cavity Squamous Cell Cancer in Order to Improve the Rate of Pathological Complete Response [NCT01914900]Phase 214 participants (Actual)Interventional2012-06-30Completed
A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer [NCT03003962]Phase 3669 participants (Actual)Interventional2017-01-02Active, not recruiting
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer [NCT00337532]Phase 2/Phase 350 participants Interventional2005-05-31Completed
Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS) [NCT05827523]Phase 3520 participants (Anticipated)Interventional2023-05-31Recruiting
Randomized Phase II Trial of Radiotherapy With Concurrent Cisplatin +/- Concurrent Cetuximab for HPV-Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC) in KRAS-Variant Patients [NCT04106362]Phase 21 participants (Actual)Interventional2020-01-14Terminated(stopped due to low enrollment)
Implementation and Evaluation of PIPAC for the Treatment of Patients With Peritoneal Carcinomatosis - a Feasibility Study. [NCT02320448]Phase 235 participants (Actual)Interventional2015-03-31Completed
Cisplatin Based Regimen to Patients With Advanced Pancreatic Cancer and Homologous Recombination Deficiency [NCT06095141]Phase 2/Phase 330 participants (Anticipated)Interventional2023-12-01Recruiting
Phase II Trial of Xevinapant and Chemoradiotherapy in Adjuvant Treatment for Patients With Head and Neck Squamous Cell Carcinoma With High Risk Pathologic Features [NCT06084845]Phase 2180 participants (Anticipated)Interventional2024-01-10Not yet recruiting
A Phase I Study of M6620 (VX-970, Berzosertib) in Combination With Cisplatin and XRT in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121) [NCT02567422]Phase 145 participants (Anticipated)Interventional2017-04-17Active, not recruiting
Neoadjuvant Three-component Chemotherapy Based on a Combination of Doxorubicin, Cisplatin and Methotrexate in Patients Aged 24-40 Years With Primary Bone Tumors to Increase the Response Rate Compared With Two-component Chemotherapy [NCT05057130]Phase 2/Phase 350 participants (Anticipated)Interventional2022-01-10Recruiting
Phase II Randomized Trial of Radiotherapy With or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) With TP53 Sequencing [NCT02734537]Phase 2189 participants (Anticipated)Interventional2016-11-23Recruiting
A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma [NCT04848753]Phase 3663 participants (Actual)Interventional2021-06-23Active, not recruiting
A Phase III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer [NCT02215265]Phase 31,100 participants (Anticipated)Interventional2015-10-31Recruiting
A MULTICENTER, OPEN-LABEL, PHASE 1B/2 STUDY TO EVALUATE SAFETY AND EFFICACY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH CHEMOTHERAPY WITH OR WITHOUT OTHER ANTI-CANCER IMMUNOTHERAPIES AS FIRST-LINE TREATMENT IN PATIENTS WITH ADVANCED MALIGNANCIES [NCT03317496]Phase 1/Phase 267 participants (Actual)Interventional2017-12-21Terminated(stopped due to The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).)
A Randomized, Controlled, Double-blind, Multi-center Phase â…¢ Registration Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions [NCT04914598]Phase 3290 participants (Anticipated)Interventional2021-05-31Not yet recruiting
Phase III Clinical Trial of Intravenous Paclitaxel Plus Intraperitoneal Cisplatin for Neo-adjuvant Chemotherapy in Patients With Advanced Ovarian Cancer [NCT04885270]Phase 350 participants (Anticipated)Interventional2021-08-04Recruiting
A Non-comparative Randomized 2:1 Phase II Study of Docetaxel, Cisplatin, and 5-fluorouracil in Combination or Not With Atezolizumab in Patients With Metastatic or Unresectable Locally Advanced Squamous Cell Anal Carcinoma [NCT03519295]Phase 299 participants (Anticipated)Interventional2018-07-22Active, not recruiting
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic [NCT02453282]Phase 31,118 participants (Actual)Interventional2015-07-21Active, not recruiting
A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT04282070]Phase 191 participants (Actual)Interventional2020-03-27Active, not recruiting
Clinical Study of Adbelizumab Combined With Concurrent Chemoradiotherapy in Locally Advanced Cervical Cancer [NCT06149767]Phase 226 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination With Chemotherapy for the First Line Treatment for Patients With Advanced Biliary Tract Cancers (TOURMALINE) [NCT05771480]Phase 3140 participants (Anticipated)Interventional2023-08-16Recruiting
Combined Therapy Using D-TACE, Gemcitabine and Cisplatin Chemotherapy, and PD1 Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Single-center, Single-arm Trial [NCT05738057]Phase 222 participants (Anticipated)Interventional2023-06-30Recruiting
A Prospective Study of Dynamic Monitoring Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy [NCT03559803]58 participants (Actual)Interventional2016-10-31Active, not recruiting
A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junctio [NCT00583674]Phase 2171 participants (Actual)Interventional2007-12-31Completed
A Pilot, Randomized, Self-controlled Study of the Effects of Intratympanic Sodium Thiosulfate on the Degree of Hearing Loss in Patients Receiving Cisplatin Therapy [NCT01369641]1 participants (Actual)Interventional2011-08-24Terminated(stopped due to Poor accrual)
The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train. [NCT05816694]Phase 250 participants (Anticipated)Interventional2023-04-30Not yet recruiting
Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors [NCT01014598]Phase 111 participants (Actual)Interventional2007-12-04Completed
A Single-Arm, Single-Center Phase II Clinical Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in The Treatment of Stage IIA2 To IVA (2018 FIGO) Locally Advanced Cervical Cancer [NCT05105672]Phase 220 participants (Anticipated)Interventional2021-03-08Recruiting
International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer [NCT00254904]Phase 3839 participants (Actual)Interventional2005-11-30Terminated(stopped due to See Termination Reason in Detailed Description)
Definitive Concurrent Hypofractionated Radiotherapy With Weekly Cisplatin in Locally Advanced Squamous Cell Carcinoma Head and Neck (SCCHN) [NCT03880396]62 participants (Actual)Observational2019-03-10Completed
A Phase 2a Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of th [NCT03515538]Phase 248 participants (Actual)Interventional2018-07-12Completed
Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung [NCT00102531]Phase 1/Phase 219 participants (Actual)Interventional2005-01-12Completed
Safety and Efficacy of Gemcitabine Based Neoadjuvant Chemotherapy Followed by Chemoradiation in Locally Advanced Cervical Cancer Patients and Association With Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression [NCT02309658]Phase 250 participants (Actual)Interventional2013-09-30Completed
Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in Induction Chemotherapy Plus Concurrent Chemoradiotherapy for Locoregionally Advanced NPC: a Phase 3, Multicentre, Non-inferiority, Randomised Factorial Trial [NCT03503136]Phase 3632 participants (Anticipated)Interventional2018-06-30Not yet recruiting
A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer [NCT01111942]Early Phase 14 participants (Actual)Interventional2010-02-28Terminated(stopped due to lack of enrollment)
Phase I Trial Of Cisplatin And KML-001 In Advanced Non-Small Cell Lung Cancer and Other Platinum Responsive Malignancies [NCT01110226]Phase 123 participants (Actual)Interventional2010-04-27Terminated(stopped due to Toxicity was not felt to be acceptable for further development.)
Randomised Phase-III-trial of Simultaneous Radiochemotherapy (RCT) of Locally Advanced Head and Neck Cancer in the Stages III and IV A-B: Comparing Dose Reduced Radiotherapy (63,6 Gy) With Paclitaxel/Cisplatin to Standard Radiotherapy (70,2 Gy) With 5-Flu [NCT01126216]Phase 3221 participants (Actual)Interventional2010-06-30Terminated(stopped due to "After an Interims analysis the Data Safety Monitoring board recommended this because no significant difference between the two arms was seen and was not expected with an reasonable recruitment of patients.~No interruptions of the trial were made.")
An Open Label Randomized Controlled Phase II Trial of Panitumumab in Combination With Epirubicin, Cisplatin and Capecitabine (ECX) Versus ECX Alone in Subjects With Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction. [NCT01234324]Phase 2171 participants (Actual)Interventional2010-10-31Completed
Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients [NCT02199418]Phase 2132 participants (Actual)Interventional2013-01-31Completed
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT05563480]Phase 290 participants (Anticipated)Interventional2022-10-27Recruiting
A Phase I Study of TS-1, Cisplatin & RAD001 (Everolimus) [NCT01096199]Phase 135 participants InterventionalTerminated
Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients [NCT01096745]Phase 278 participants (Anticipated)Interventional2010-07-31Terminated(stopped due to Planning for randomized phase III trial for this issue.)
A Multi-center Phase III Randomized Controlled Trial Comparing Between Adjuvant Chemotherapy and Observation in High Risk Patients With Completely Resected Stage Ib Lung Adenocarcinoma [NCT02281708]Phase 31,012 participants (Anticipated)Interventional2014-10-31Recruiting
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy: a Patient Preference Multicenter Randomized Phase II Trial [NCT06084897]Phase 2120 participants (Anticipated)Interventional2023-10-16Recruiting
A Multi-Center, Randomized Phase III Study of Neoadjuvant Anti-PD-1 Immunotherapy Plus TP Chemotherapy Versus TP Chemotherapy or Up-Front Surgery in Resectable Locally Advanced Oral Squamous Cell Carcinoma [NCT05798793]Phase 3309 participants (Anticipated)Interventional2023-11-20Not yet recruiting
KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinic [NCT05294172]Phase 3295 participants (Actual)Interventional2022-06-16Active, not recruiting
Phase I Study of TRC102 in Combination With Cisplatin and Pemetrexed in Patients With Advanced Solid Tumors / Phase II Study of TRC102 With Pemetrexed in Patients Refractory to Pemetrexed and Cisplatin or Carboplatin [NCT02535312]Phase 1/Phase 230 participants (Actual)Interventional2016-03-08Active, not recruiting
Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study [NCT00968799]6 participants (Actual)Interventional2008-02-29Terminated(stopped due to poor patient accrual)
A Randomized Phase I/II Study of Standard Chemotherapy (Cisplatin and Pemetrexed) With or Without Axitinib in Patients With Malignant Mesothelioma: Interim Biopsy Analysis to Determine Efficacy [NCT01211275]Phase 1/Phase 232 participants (Actual)Interventional2009-05-22Completed
A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus [NCT00492778]Phase 2165 participants (Actual)Interventional2008-02-25Active, not recruiting
A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features [NCT05382338]Phase 3225 participants (Anticipated)Interventional2023-02-20Recruiting
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE- [NCT04634877]Phase 3990 participants (Anticipated)Interventional2021-01-10Active, not recruiting
A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers [NCT03768414]Phase 3452 participants (Actual)Interventional2019-02-07Active, not recruiting
A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Protocol [NCT03737994]Phase 210 participants (Actual)Interventional2019-07-25Active, not recruiting
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) [NCT03533582]Phase 2/Phase 3537 participants (Anticipated)Interventional2018-05-24Recruiting
A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors [NCT03067181]Phase 32,059 participants (Anticipated)Interventional2017-05-25Recruiting
A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients [NCT02724579]Phase 245 participants (Anticipated)Interventional2017-11-17Recruiting
Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment [NCT00980460]Phase 3236 participants (Actual)Interventional2009-09-14Active, not recruiting
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC) [NCT00324805]Phase 31,501 participants (Actual)Interventional2007-06-01Active, not recruiting
PEI REGIMEN: A THERAPEUTIC OPTION IN SMALL CELL LUNG CANCER? A MONOINSTITUTIONAL EXPERIENCE OF 46 CONSECUTIVE CASES [NCT02324296]46 participants (Actual)Observational1998-12-31Completed
Cisplatin and Sodium Thiosulfate Otoprotection With or Without SAHA/Vorinostat Histone Deacetylase Inhibition for Relapsed/Refractory Hepatoblastoma and Other Embryonal Tumors [NCT05756660]Early Phase 133 participants (Anticipated)Interventional2023-03-01Recruiting
Chidamide Combined With Cisplatin in Recurrent or Metastatic Head and Neck Adenoid Cystic Carcinoma: A Prospective, Open-label, Phase II Study of a Single Center [NCT03639168]Phase 222 participants (Actual)Interventional2018-06-06Completed
Clinical Study of Disulfiram Combined With Cisplatin in the Treatment of Advanced Gastric Cancer [NCT05667415]40 participants (Anticipated)Interventional2023-06-01Not yet recruiting
A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients [NCT01100801]Phase 290 participants (Anticipated)Interventional2010-07-31Recruiting
A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites [NCT01327235]Phase 2336 participants (Actual)Interventional2011-03-31Completed
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease [NCT00025259]Phase 31,734 participants (Actual)Interventional2002-09-30Completed
Randomized Phase II Study of Two Different Regimens of TPF Induction Chemotherapy Regimen Followed by Radiation Therapy Plus Cetuximab (TPF-CET-HART) vs. HART and Cis-platinum, 5-FU (PF-HART) in Patients With Locally Advanced Unresectable Squamous Cell Ca [NCT01181401]Phase 294 participants (Actual)Interventional2010-08-31Completed
A Phase I Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes [NCT00003377]Phase 129 participants (Actual)Interventional1999-11-30Completed
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer [NCT01874678]45 participants (Actual)Interventional2011-03-31Completed
A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL) [NCT03126916]Phase 3724 participants (Anticipated)Interventional2018-05-14Active, not recruiting
Cytoreductive Surgery Plus Hyperthermic Intraoperative Peritoneal Chemotherapy With Cisplatin to Treat Peritoneal Carcinomatosis From Upper Gastrointestinal Cancer; the HIPCUpp-trial [NCT01116791]Phase 234 participants (Actual)Interventional2010-07-31Terminated(stopped due to Insufficient enrollment in Pancreatic & Biliary arm)
Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial [NCT03814759]Phase 2102 participants (Anticipated)Interventional2016-12-12Recruiting
Perioperative Versus Preoperative Chemotherapy With Surgery in Patients With Locoregional Squamous Carcinoma of Esophagus [NCT01225523]Phase 1350 participants (Actual)Interventional1997-01-31Completed
Efficacy and Safety of Anlotinib Combined With Platinum Plus Pemetrexed in T790M Mutation Negative Metastastic Non-squamous Non-small-cell Lung Cancer After Progression on First-line EGFR TKI: a Phase II, Muti-center, Single Arm Study [NCT03706287]Phase 1/Phase 262 participants (Anticipated)Interventional2018-12-06Recruiting
Phase II Open-label Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Systemic Therapy for Locally Advanced or Metastatic Nasopharyngeal Carcinoma (NPC) [NCT01309633]Phase 280 participants (Actual)Interventional2011-09-02Completed
Adjuvant Chemotherapy Versus Observation After Radiation With Concurrent Cisplatin of Cervical Cancer (With Pelvic or Para-aortic Node Involvement) :A Phase 3 Prospective Multi-institutional Randomised Controlled Trial [NCT03468010]Phase 3432 participants (Anticipated)Interventional2018-03-01Recruiting
Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01245959]Phase 3476 participants (Anticipated)Interventional2011-01-31Active, not recruiting
A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable [NCT01248299]Phase 2105 participants (Actual)Interventional2011-01-31Terminated
Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A [NCT01858922]Phase 240 participants (Actual)Interventional2012-12-19Active, not recruiting
Phase I Trial of MK-3475 and Concurrent Chemo/Radiation for the Elimination of Small Cell Lung Cancer [NCT02402920]Phase 183 participants (Actual)Interventional2015-07-22Active, not recruiting
Phase II Randomized Trial Comparating Two Concomitant Administration of Radiotherapy With Cisplatin in Patients With Not Operated or Inoperable HNSCC or With Recurrence High Risk in Adjuvant Postoperative Treatment [NCT03330249]Phase 2124 participants (Actual)Interventional2015-12-03Completed
An Open Label Dose Escalation and Pharmacokinetic Phase I Study With Pazopanib in Combination With Cisplatin (CDDP) Every Three Weeks in Patients With Advanced Solid Tumors [NCT01165385]Phase 135 participants (Actual)Interventional2010-06-30Completed
JS001 Combined With Nab-paclitaxel and Cisplatin or Carboplatin as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma : a Prospective, Single Arm, Single Center, Phase II Clinical Trial [NCT05173246]Phase 243 participants (Anticipated)Interventional2020-11-17Recruiting
A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer [NCT01282151]Phase 3148 participants (Actual)Interventional2011-07-31Terminated(stopped due to Difficulty in recruitment due to approval of maintenance pemetrexed treatment)
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma [NCT01171781]Phase 2110 participants (Anticipated)Interventional2009-11-30Recruiting
Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer [NCT01284413]Phase 1/Phase 268 participants (Actual)Interventional2010-12-31Completed
"An Open-label, Multi-center, Non-randomized Phase Ib Study to Investigate the Safety, Efficacy, and Pharmacokinetics of BAY 73-4506 Regorafenib, Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Nonsquamous Non-Small Cel [NCT01187615]Phase 19 participants (Actual)Interventional2010-08-31Terminated
A Phase III Study to Investigate the Differential Influence of Prior Chemotherapy on the Efficacy of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer (IIIB, IV) With or Without EGFR Gene Mutation [NCT01204307]Phase 2101 participants (Actual)Interventional2010-01-31Completed
A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer [NCT02501278]Phase 20 participants (Actual)Interventional2016-05-31Withdrawn(stopped due to company (Inovio) is no longer able to support the study)
Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Single-center, Phase II Clinical Study [NCT05588219]Phase 230 participants (Anticipated)Interventional2022-12-01Recruiting
PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer [NCT04481204]Phase 2105 participants (Actual)Interventional2023-04-18Active, not recruiting
A Phase I Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN) [NCT00627835]Phase 10 participants (Actual)InterventionalWithdrawn(stopped due to Site decided not to open this study)
NASSIST (Neoadjuvant Chemoradiation +/- Immunotherapy Before Surgery for Superior Sulcus Tumors): A Randomized Phase II Trial of Trimodality +/- Atezolizumab in Resectable Superior Sulcus Non-Small Cell Lung Cancer [NCT04989283]Phase 20 participants (Actual)Interventional2021-09-09Withdrawn(stopped due to Due to no accrual)
A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed With Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma [NCT03228537]Phase 129 participants (Actual)Interventional2018-07-16Active, not recruiting
A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer [NCT02466971]Phase 3437 participants (Actual)Interventional2016-05-10Active, not recruiting
A Randomized Phase II Non-inferiority Study of Two Cycles Versus Three Cycles of Cisplatin Based Concurrent Chemoradiotherapy for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma Based on Pretreatment Plasma EBV DNA Level [NCT02871518]Phase 2236 participants (Anticipated)Interventional2016-08-31Recruiting
Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer. [NCT00915850]Phase 1/Phase 232 participants (Anticipated)Interventional2007-08-31Recruiting
CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors [NCT01014767]Phase 327 participants (Actual)Interventional2009-11-30Terminated(stopped due to PI departure from coordinating institution)
Phase I Trial of BYL719 in Combination With Concurrent Cisplatin-based Chemoradiotherapy in Patients With Locoregionally Advanced Squamous Cell Carcinoma of Head and Neck (LA-SCCHN) [NCT02537223]Phase 19 participants (Actual)Interventional2015-09-30Completed
A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy [NCT04628767]Phase 2/Phase 3249 participants (Anticipated)Interventional2021-11-12Recruiting
Phase 2 Single Arm Trial of Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma (HNSCC) [NCT02270814]Phase 274 participants (Actual)Interventional2015-02-02Active, not recruiting
Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma [NCT00742924]Phase 124 participants (Actual)Interventional2008-08-31Completed
A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer [NCT01005329]Phase 234 participants (Actual)Interventional2009-11-06Completed
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation With or Without P276-00 [NCT01903018]Phase 273 participants (Actual)Interventional2012-07-31Completed
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial) [NCT05419089]Phase 2199 participants (Anticipated)Interventional2022-07-12Recruiting
A Phase II Study Incorporating Bone Marrow Microenvironment (ME) - Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DTPACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance [NCT00572169]Phase 3177 participants (Actual)Interventional2006-11-30Active, not recruiting
A Prospective,Randomized,Controlled,Multicenter,Phase III Study of Stage â…¢ Study of Gemcitabine Plus Cisplatin With or Without Endostatin to the Metastatic Nasopharyngeal Carcinoma [NCT01915134]Phase 3362 participants (Anticipated)Interventional2013-08-31Recruiting
A Randomised Study of TPF as Neoadjuvant Chemotherapy Followed by Concomitant Chemoradiotherapy (CRT) With Conventional Radiotherapy (RT) Versus Concomitant CRT With Accelerated RT in Patients With Locally Advanced Head and Neck Squamous Cell Cancer (HNSC [NCT00774319]Phase 270 participants (Anticipated)Interventional2008-12-31Recruiting
A Phase I Study of the PI3-Kinase Inhibitor BKM120 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors [NCT01971489]Phase 10 participants (Actual)Interventional2015-09-30Withdrawn
A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Canc [NCT00977561]Phase 29 participants (Actual)Interventional2010-04-30Terminated(stopped due to See termination reason in detailed description.)
A Phase Ib, Open-label Study of Alpelisib (BYL719) in Combination With Cisplatin in Patients With HPV+ Solid Tumor Malignancies [NCT02620839]Phase 128 participants (Actual)Interventional2016-12-01Terminated(stopped due to Funding)
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients. [NCT00659269]Phase 3319 participants (Actual)Interventional2006-07-31Completed
Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis [NCT02973386]Phase 3278 participants (Anticipated)Interventional2017-01-31Recruiting
A Prospective Study of Heated Intra-Peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin and Cisplatin in Pediatric Patients With Pelvic and Abdominal Tumors. The TOAST IT Trial (Trial Of Adjuvant Surgical Treatment With Intraperitoneal Chemotherapy) [NCT04213794]Early Phase 143 participants (Anticipated)Interventional2019-11-08Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer [NCT04005716]Phase 3457 participants (Actual)Interventional2019-07-22Active, not recruiting
Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA) [NCT00304278]Phase 221 participants (Actual)Interventional2006-03-31Completed
Role of Neoadjuvant Chemotherapy in the Conservative Management of Non-muscle Invasive Bladder Cancer (NMIBC) T1b [NCT04245618]50 participants (Anticipated)Observational2020-07-31Not yet recruiting
Feasibility and Efficacy of Molecular Analysis-Directed Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer [NCT00705549]Phase 288 participants (Actual)Interventional2008-02-29Terminated(stopped due to Due to poor accrual)
A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer [NCT00842491]Phase 245 participants (Actual)Interventional2008-11-30Completed
Phase II, Prospective, Randomized, Non-comparative Study of Treatment With Induction Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation or Definitive Chemoradiation in Invasive Locally Advanced Carcinomas of Uterine Cervix. [NCT01973101]Phase 2120 participants (Anticipated)Interventional2012-06-30Recruiting
Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial [NCT05979961]Phase 3424 participants (Anticipated)Interventional2023-08-31Not yet recruiting
AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB - LR and PNET 5 MB - WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR), OR TP53 MUTATION, AND REGISTRY FOR MB OCCU [NCT02066220]Phase 2/Phase 3360 participants (Anticipated)Interventional2014-06-30Active, not recruiting
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy With Concurrent Weekly Cisplatin in Patients With Stage I-IVA Cervical Cancer Who Have FDG PET Positive Pelvic or Para-Aortic Lymph Nodes [NCT00590967]Phase 269 participants (Actual)Interventional2003-05-31Terminated(stopped due to Due to low accrual)
A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT04974398]Phase 3298 participants (Anticipated)Interventional2021-08-16Recruiting
GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma:a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial [NCT03840421]Phase 3468 participants (Anticipated)Interventional2019-04-03Active, not recruiting
An Exploratory Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody) Combined With Chemotherapy in Patients With Advanced Solid Tumors. [NCT03577704]Phase 1/Phase 256 participants (Actual)Interventional2018-08-08Completed
An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors [NCT02937116]Phase 1233 participants (Actual)Interventional2016-10-19Completed
Exploratory Study of Molecular Phenotype Changes and Personalized Treatment for Patients With Castration Resistant Prostate Cancer [NCT02208583]150 participants (Anticipated)Interventional2014-06-30Recruiting
Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study) [NCT02709512]Phase 2/Phase 3249 participants (Actual)Interventional2017-08-01Completed
Immunochemotherapy: Do Platin-based Chemotherapeutics Enhance Dendritic Cell Vaccine Efficacy in Melanoma Patients? [NCT02285413]Phase 254 participants (Actual)Interventional2011-02-28Completed
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients [NCT01755897]337 participants (Actual)Interventional2012-11-30Completed
A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061) [NCT01595061]Phase 257 participants (Actual)Interventional2012-07-02Active, not recruiting
[NCT02513355]Phase 4400 participants (Anticipated)Interventional2015-02-28Recruiting
A Randomized Non-inferiority Trial of Radiotherapy Plus Nimotuzumab or Cisplatin in Patients With Favorable Response to Induction Chemotherapy for Low-risk Locoregionally Advanced-Staged Nasopharyngeal Carcinoma [NCT04456322]Phase 3326 participants (Anticipated)Interventional2020-07-06Recruiting
Phase II Study Comparing Gemcitabine Plus Cisplatin to Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma [NCT02016417]Phase 2120 participants (Anticipated)Interventional2014-05-31Not yet recruiting
A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX) [NCT06056310]Phase 140 participants (Anticipated)Interventional2024-01-09Not yet recruiting
Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer; Multicenter Randomized Phase 3 Study [NCT02114359]Phase 3111 participants (Actual)Interventional2014-02-28Completed
Phase II Study Comparing Intensity Modulated Radiotherapy (IMRT) in Combination With Concurrent Chemotherapy and IMRT Alone for Stage II Nasopharyngeal Carcinoma [NCT02116231]Phase 280 participants (Anticipated)Interventional2014-04-30Not yet recruiting
Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer [NCT02128243]Phase 2242 participants (Actual)Interventional2014-09-30Completed
Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia [NCT03249519]999 participants (Anticipated)Interventional2017-08-01Recruiting
Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial [NCT03068936]Phase 3716 participants (Anticipated)Interventional2017-03-31Not yet recruiting
Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC [NCT02064491]Phase 218 participants (Actual)Interventional2014-02-28Completed
Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma: A Randomized Phase III Trial [NCT04898374]Phase 3120 participants (Anticipated)Interventional2021-05-01Recruiting
Phase II Clinical Randomized Study of the Effect of Chronomodulated Chemotherapy Followed by Concurrent IMRT Chemo-radiotherapy on the Dendritic Cells Subsets and Immunity in the Treatment of Advanced Nasopharyngeal Cancer [NCT03196869]Phase 2128 participants (Anticipated)Interventional2017-04-07Recruiting
[NCT02444949]Phase 275 participants (Actual)Interventional2014-06-30Completed
Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial [NCT03194061]20 participants (Actual)Interventional2015-01-01Active, not recruiting
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043) [NCT04846634]Phase 290 participants (Anticipated)Interventional2021-08-31Not yet recruiting
Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study [NCT02429037]Phase 260 participants (Anticipated)Interventional2015-05-31Not yet recruiting
A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma [NCT06172296]Phase 3478 participants (Anticipated)Interventional2024-02-14Not yet recruiting
Reduced-dose Radiotherapy With/Without Concurrent Chemotherapy Versus Standard Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Complete Response After Induction Chemotherapy Plus Immunotherapy: a Randomized, O [NCT06092957]Phase 3504 participants (Anticipated)Interventional2023-10-09Recruiting
Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer [NCT04711824]Phase 1/Phase 241 participants (Anticipated)Interventional2022-03-09Recruiting
A Phase II Pilot Trial Of Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and the Addition Of Paricalcitol Upon Disease Progression in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NABPLAGEMD) [NCT03415854]Phase 211 participants (Actual)Interventional2018-01-31Completed
A Phase I Study of Ceritinib (LDK378), a Novel ALK Inhibitor, in Combination With Gemcitabine-Based Chemotherapy in Patients With Advanced Solid Tumors [NCT02227940]Phase 138 participants (Anticipated)Interventional2015-01-08Completed
A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of M701, a Recombinant Epcam and CD3 Bispecific Antibody , in Patients With Malignant Pleural Effusions Caused by NSCLC [NCT05543330]Phase 1/Phase 296 participants (Anticipated)Interventional2022-09-30Not yet recruiting
A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen. [NCT02414685]Phase 219 participants (Actual)Interventional2015-04-30Completed
A Phase Ib Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers (PANTHEoN) [NCT04892875]Phase 10 participants (Actual)Interventional2023-12-31Withdrawn(stopped due to Funding)
IMMUNOCERV: Evaluating the Safety of Chemoradiation Combined With PDS0101 Immunotherapy in Treating Locally Advanced Cervical Cancer [NCT04580771]Phase 235 participants (Anticipated)Interventional2020-10-14Recruiting
A Phase I Trial of AT13387 in Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN) Receiving Concurrent Radiation and Cisplatin [NCT02381535]Phase 12 participants (Actual)Interventional2015-09-21Active, not recruiting
Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA) [NCT02135042]Phase 2/Phase 3685 participants (Actual)Interventional2014-04-21Active, not recruiting
Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant [NCT00082706]Phase 246 participants (Actual)Interventional2003-04-23Active, not recruiting
A Phase I Study of Nelfinavir and Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Vulvar Cancer Not Amenable to Surgical Resection [NCT04169763]Phase 118 participants (Anticipated)Interventional2020-08-07Recruiting
Immuno-Chemotherapy as Single Treatment Modality for Larynx Preservation (ICoLP) [NCT04030455]Phase 225 participants (Anticipated)Interventional2019-08-07Recruiting
A Multicenter, Phase II Clinical Study of AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) Alone or in Combination With Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma [NCT05522894]Phase 280 participants (Anticipated)Interventional2022-10-01Not yet recruiting
DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy [NCT05541016]Phase 2320 participants (Anticipated)Interventional2023-02-21Recruiting
CASPIAN-RT Trial: Hypofractionated Consolidative Radiation Therapy After Durvalumab (MEDI4736) Plus Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer [NCT05161533]Phase 20 participants (Actual)Interventional2023-10-19Withdrawn(stopped due to Closed per SRC Low Accrual Policy. Study closed prior to any participants enrolled.)
A Phase II, Single-Arm Trial Assessing Local Control of Near Total Endoscopic Resection Followed by Concurrent Chemotherapy and Proton Radiation in the Treatment of Unresectable Sinonasal Tumors [NCT03274414]Phase 23 participants (Actual)Interventional2017-09-01Completed
A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel and Cisplatin/Carboplatin With or Without Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck [NCT01064479]Phase 2123 participants (Actual)Interventional2010-02-05Completed
An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase 1 Study With Ombrabulin Administered as a 30-minute Intravenous Infusion in Combination With Cisplatin Administered as an Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid [NCT01021150]Phase 112 participants (Anticipated)Interventional2010-03-31Completed
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma [NCT02281955]Phase 2115 participants (Actual)Interventional2014-08-31Active, not recruiting
Pilot Study of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Colorectal Cancer at High Risk for the Development of Metachronous Peritoneal Metastases [NCT02575859]Phase 1/Phase 220 participants (Actual)Interventional2006-01-31Completed
The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma [NCT06138028]Phase 2/Phase 390 participants (Anticipated)Interventional2023-09-20Recruiting
A Prospective, Single-arm, Exploratory Study on the Efficacy and Safety of Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Patients With Neuroendocrine Bladder Carcinoma [NCT06091124]Phase 222 participants (Anticipated)Interventional2023-11-16Recruiting
A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma [NCT05823311]Phase 380 participants (Anticipated)Interventional2023-10-31Recruiting
Neoadjuvant Chemotherapy Plus Cystectomy vs Cystectomy Alone for cT0 Muscle-invasive Bladder Cancer After Maximal TURBt: Multicentre Prospective Randomized Controlled Trial [NCT05776758]Phase 3236 participants (Anticipated)Interventional2023-11-30Recruiting
A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine/Cisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma [NCT05655949]Phase 230 participants (Anticipated)Interventional2023-12-31Recruiting
A Phase â…¡, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma [NCT05532059]Phase 2100 participants (Anticipated)Interventional2022-01-31Recruiting
Phase II Study of Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer [NCT05521997]Phase 242 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian C [NCT05415709]Early Phase 145 participants (Anticipated)Interventional2022-06-13Recruiting
Randomised Phase II Trial of Cediranib (AZD2171) Versus Placebo in Addition to Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers [NCT00939848]Phase 2/Phase 3124 participants (Actual)Interventional2011-04-30Completed
Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen [NCT00454636]Phase 2158 participants (Actual)Interventional2007-03-31Completed
A Phase II Study of Efficacy and Safety of Paclitaxel and Cisplatin Every 2 Weeks as the First-line Treatment of Patients With Ovarian Cancer Stage Ic-IV. [NCT00964626]Phase 260 participants (Anticipated)Interventional2009-04-30Recruiting
Paclitaxel In Combination With Cisplatin and 5-fluorouracil(TPF) Induction Chemotherapy for Locally Advanced Borderline-resectable Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial [NCT02976909]Phase 246 participants (Actual)Interventional2016-10-31Completed
Atezolizumab With Platinum and Etoposide Chemotherapy Followed by Cystectomy for Patients With Localized Small Cell Neuroendocrine Bladder Cancer [NCT05312671]Phase 263 participants (Anticipated)Interventional2022-06-27Recruiting
A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial [NCT00758381]Phase 2114 participants (Anticipated)Interventional2007-08-31Recruiting
Phase II Prospective Study Evaluating the Role of Directed Cisplatin Based Chemo With Either Vinorelbine or Pemetrexed for the Adj Tx of Early Stage NSCLC in Patients Using Genomic Expression Profiles of Chemo Sensitivity to Guide Therapy [NCT00545948]Phase 231 participants (Actual)Interventional2007-12-31Terminated(stopped due to Study terminated due to reproducibility issues with genomics prediction model.)
Phase II Trial of Etoposide Plus Cisplatin Compared With Irinotecan Plus Cisplatin for First-line Treatment of Non-primary Pancreatic Metastatic and/or Unresectable Gastrointestinal Neuroendocrine Tumor G3 Type [NCT03963193]Phase 2112 participants (Anticipated)Interventional2019-06-01Not yet recruiting
Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer [NCT00976976]Phase 246 participants (Actual)Interventional2007-05-31Completed
Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cispla [NCT00771563]Phase 3104 participants (Actual)Interventional2008-06-30Completed
Phase 1/2, Open-Label, Single-Arm Safety and Efficacy Dose-Finding, Systemic Exposure, and Device Technical Effects of PRV111 (Cisplatin Transmucosal System) in Subjects With Oral Squamous Cell Carcinoma [NCT03502148]Phase 1/Phase 210 participants (Actual)Interventional2018-06-19Completed
A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer [NCT00408694]Phase 246 participants (Actual)Interventional2006-12-13Completed
A Phase II Study of Sorafenib With Gemcitabine/Cisplatin in Advanced Hepatocellular Carcinoma [NCT00808145]Phase 20 participants (Actual)Interventional2009-02-28Withdrawn(stopped due to Lack of enrollment, many screen failures and non eligible study participants)
Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence [NCT00817895]150 participants (Actual)Interventional2008-12-31Completed
Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer [NCT00381706]Phase 2245 participants (Actual)Interventional2006-09-15Completed
A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subje [NCT00454779]Phase 2113 participants (Actual)Interventional2007-01-01Completed
A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperati [NCT00626639]Phase 1/Phase 25 participants (Actual)Interventional2005-07-31Completed
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN [NCT04550260]Phase 3640 participants (Actual)Interventional2020-10-19Active, not recruiting
A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer [NCT04486833]Phase 1/Phase 2158 participants (Anticipated)Interventional2021-09-03Recruiting
A Phase 1 Dose-Finding Study Of The Anti-Angiogenesis Agent, AG-013736, In Combinations Of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, Gemcitabine/Cisplatin and Pemetrexed/Cisplatin In Patients With Advanced Solid Tumors [NCT00454649]Phase 1102 participants (Actual)Interventional2005-12-31Completed
A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer [NCT00003298]Phase 239 participants (Actual)Interventional1999-06-01Completed
Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin [NCT01970722]Phase 140 participants (Anticipated)Interventional2014-05-19Active, not recruiting
Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb [NCT00432315]Phase 280 participants (Actual)Interventional2001-05-31Completed
Phase II Randomized Controlled Trial on the Safety and Efficacy of 4 Versus 6 Courses of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients Previously Treated With Neoadjuvant Chemotherapy Plus Radical Surgery [NCT02365935]215 participants (Actual)Interventional2007-02-28Completed
A Phase 1/2, Open-label, Dose-exploration and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NTX-301 Monotherapy in Advanced Solid Tumours, and in Combination With Platinum-based Chemotherapy in Advanced Ova [NCT04851834]Phase 1/Phase 212 participants (Actual)Interventional2021-08-25Terminated(stopped due to Study was terminated by IP Holder (collaborator), PinotBio Inc.)
Randomized, Controlled Study of the Safety and Efficacy of DC-CTL Immune Cell for Non-Small Cell Lung Cancer [NCT02766348]Phase 260 participants (Anticipated)Interventional2016-05-31Not yet recruiting
Randomized Phase III Trial Evaluating the Role of Autologous Stem Cell Transplantation in Previously Untreated Patients With Stage B and C Chronic Lymphocytic Leukemia [NCT00931645]Phase 3241 participants (Actual)Interventional2001-04-30Completed
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01854203]Phase 2/Phase 3300 participants (Anticipated)Interventional2013-07-31Recruiting
A Phase II Study of Sodium Thiosulfate (STS) for Prevention of Ototoxicity in Patients With Locally Advanced Squamous Cell Carcinoma of Head and Neck (SCCHN) Undergoing Concurrent Chemoradiation With Cisplatin [NCT04541355]Phase 216 participants (Actual)Interventional2020-10-14Completed
A Phase III, Multicenter, Randomized Study of ABX Plus Cisplatin (AP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer [NCT02546934]Phase 3254 participants (Anticipated)Interventional2016-03-31Completed
Phase II Clinical Trial With Metronomic Oral Vinorelbine and Tri-weekly Cisplatin as Induction Therapy and Subsequent Concomitantly With Radiotherapy (RT) in Patients With Lung Cancer (NSCLC) Locally Advanced Unresectable [NCT02709720]Phase 267 participants (Actual)Interventional2016-04-15Completed
A Phase II, Prospective, Open-label Clinical Trial of Pre-Operative PD-1 Antibody (Toripalimab) + Chemoradiotherapy in Patients With Locally Advanced Esophageal Cancer [NCT04177875]Phase 244 participants (Anticipated)Interventional2019-05-01Recruiting
Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer [NCT00635726]Phase 241 participants (Actual)Interventional2008-02-29Terminated(stopped due to Due to poor accrual)
A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and [NCT02022098]144 participants (Actual)Interventional2013-10-31Completed
Phase II Clinical Study of Patients Randomized, Open, Controlled Evaluation of Autologous Tumor Tissue Antigen Sensitized DC-CIK Cells Combined With Chemotherapy in the Treatment of Patients With Esophageal Resection [NCT02644863]Phase 260 participants (Anticipated)Interventional2015-12-31Recruiting
Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer [NCT00657423]Phase 380 participants (Anticipated)Interventional2008-04-30Recruiting
Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma:a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study [NCT04437329]Phase 3352 participants (Anticipated)Interventional2020-08-01Recruiting
Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion [NCT02657460]Phase 290 participants (Anticipated)Interventional2016-01-31Recruiting
A Phase II Study to Evaluate the Efficacy and Safety of Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Unresectable Locally Advanced or Metastatic Urothelial Carcinoma [NCT04211012]Phase 230 participants (Anticipated)Interventional2020-11-30Not yet recruiting
Prospective Randomized Trial Comparing Induction Chemotherapy and Immunotherapy Combined Radiotherapy With or Without Concurrent Chemotherapy for Stage III-IVa Nasopharyngeal Carcinoma [NCT06095167]Phase 3476 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Phase II Randomised Controlled Study Assessing the Role of Dose Escalation Using [18F] FMISO PET CT in Head and Neck Cancer: The DE-HyART (Dose Escalation Using Hypoxia-adjusted Radiotherapy) Protocol [NCT06087614]Phase 2124 participants (Anticipated)Interventional2023-10-31Recruiting
Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. (NECTORS Trial) [NCT04277858]Phase 260 participants (Anticipated)Interventional2018-08-14Recruiting
A Randomized Phase II Trial of Docetaxel, Cisplatin, and Hypofractionated Radiotherapy Versus Docetaxel and Cisplatin for Limited Volume Stage IV Non-small Cell Lung Cancer: The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere [NCT00887315]Phase 211 participants (Actual)Interventional2009-04-30Terminated(stopped due to Slow accrual and loss of sponsor)
A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Small Cell Lung Cancer [NCT00887159]Phase 2168 participants (Actual)Interventional2009-07-16Completed
Randomized phase2 Study of IP vs. GP as the First-line Therapy Followed by Two Different Sequences as the 2nd or 3rd-line Therapy for Patients With Advanced NSCLC; [NCT01003964]Phase 2289 participants (Actual)Interventional2009-02-28Completed
A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metast [NCT00960349]Phase 114 participants (Actual)Interventional2009-08-31Completed
Prospective Non-inferior Clinical Trial Comparing Concurrent Chemoradiotherapy or Radiotherapy Alone in Patients With Intermediate Risk Nasopharyngeal Carcinoma in Intensity-modulated Radiotherapy Era [NCT02633202]Phase 3338 participants (Anticipated)Interventional2015-11-30Recruiting
A Randomized Phase II Clinical Trial of an Adenovirus-mediated Endostatin Gene (E10A) Combined With Cisplatin and Paclitaxel in Patients With Head and Neck Cancer [NCT00634595]Phase 2116 participants (Anticipated)Interventional2008-03-31Recruiting
Pembrolizumab + Platinum Doublets Without Radiation for Patients With PD-L1 ≥50% Locally Advanced Non-small Cell Lung Cancer: a Multicenter Prospective Single Arm Phase II Study [NCT04153734]Phase 221 participants (Anticipated)Interventional2019-12-01Not yet recruiting
A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors [NCT00072332]Phase 10 participants Interventional2003-08-31Completed
Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel and Cisplatin in Advanced Non Small Cell Lung Cancer. [NCT00680940]Phase 2221 participants (Actual)Interventional2008-06-30Completed
A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT00677118]Phase 3506 participants (Anticipated)Interventional2006-06-30Active, not recruiting
Oral Vinorelbine And Cisplatin With Concomitant Radiotherapy Followed By Either Consolidation Therapy With Oral Vinorelbine And Cisplatin Plus Best Supportive Care Or Best Supportive Care Alone In Stage III Non Small Cell Lung Cancer (NSCLC), A Randomized [NCT00683514]Phase 3201 participants (Actual)Interventional2005-04-30Completed
Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer [NCT00686322]Phase 46 participants (Actual)Interventional2008-04-30Completed
Randomized, Phase III-b, Multi-centre, Open-label, Parallel Study of Enoxaparin (Low Molecular Weight Heparin) Given Concomitantly With Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Gastric and Gastro-oesophageal Cancer [NCT00718354]Phase 3740 participants (Actual)Interventional2008-07-31Completed
Clinical Application of Efficacy Prediction Model Based on Epigenomics Sequencing Technology in Neoadjuvant Immunotherapy for Esophageal Cancer [NCT05880082]Phase 262 participants (Anticipated)Interventional2023-05-31Not yet recruiting
A Controlled Clinical Study of Envafolimab (PD-L1 Antibody) Subcutaneous Injection Combined With Endostar and Concurrent Chemoradiotherapy in Treatment of Locally Advanced Primary Cervical Cancer [NCT05879796]30 participants (Anticipated)Observational2023-05-16Not yet recruiting
An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation [NCT05504278]Phase 1144 participants (Anticipated)Interventional2022-09-20Recruiting
QUILT 2.023: A Phase 3, Open-Label, 3-Cohort Randomized Study of N-803, in Combination With Current Standard of Care VS Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic NSCLC. [NCT03520686]Phase 31,538 participants (Anticipated)Interventional2018-05-18Active, not recruiting
A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer [NCT00529100]Phase 1/Phase 249 participants (Actual)Interventional2005-12-31Completed
Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer [NCT03998696]Phase 460 participants (Actual)Interventional2017-07-01Completed
A Randomized Study of the Efficacy and Safety of OncoGelâ„¢ Treatment as an Adjunctive Therapy to Systemic Chemotherapy and Concurrent External Beam Radiation Prior to Surgery in Subjects With Localized or Loco-regional Esophageal Cancer [NCT00573131]Phase 2137 participants (Actual)Interventional2008-01-31Terminated(stopped due to OncoGel did not show any impact on overall tumor response)
A Phase I/II Trial of Intraperitoneal (IP) Cisplatin Combined With IV Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Their Initial Surgery Performed Following Neoadjuvant Intravenous Chemotherapy [NCT00889733]Phase 1/Phase 220 participants (Anticipated)Interventional2007-02-28Terminated(stopped due to Poor recruitment)
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma [NCT04003636]Phase 31,069 participants (Actual)Interventional2019-09-24Active, not recruiting
A Phase III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPSCC [NCT03811015]Phase 3636 participants (Anticipated)Interventional2019-08-16Recruiting
A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma [NCT06081673]Phase 272 participants (Anticipated)Interventional2023-10-30Recruiting
Toripalimab in Combination With Cetuximab,Cisplatin and 5-FU for Conversion Therapy of Locally Nonresectable Oral Cavity Squamous Cell Carcinoma (OCSCC) [NCT06081582]Phase 233 participants (Anticipated)Interventional2023-07-06Recruiting
Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection [NCT00254384]Phase 150 participants (Actual)Interventional2005-10-05Active, not recruiting
A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer [NCT02254278]Phase 2316 participants (Actual)Interventional2014-10-31Active, not recruiting
A Phase II Study of (Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery) for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis [NCT00512096]Phase 230 participants (Actual)Interventional1999-08-31Completed
A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion [NCT01004978]Phase 3235 participants (Actual)Interventional2009-10-28Completed
Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer [NCT04017377]15 participants (Anticipated)Interventional2019-09-01Recruiting
Safety and Efficacy of Anlotinib Hydrochloride Combined With Pemetrexed Plus Cisplatin/Carboplatin (AP) as First Line Treatment for Stage IIIB/IIIC/IV Non-squamous Non-small-cell Lung Cancer [NCT04012619]Phase 18 participants (Actual)Interventional2019-04-30Completed
Phase II Prospective Study Evaluating the Role of Personalized Chemotherapy Regimens for Chemo-Naive Select Stage IIIB and IV Non-Small Cell Lung Cancer (NSCLC) in Patients Using a Genomic Predictor of Platinum Resistance to Guide Therapy [NCT00509366]Phase 2101 participants (Actual)Interventional2007-05-31Terminated(stopped due to Study terminated due to reproducibility issues with genomics prediction model.)
An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease [NCT00400179]Phase 31,053 participants (Actual)Interventional2005-05-31Completed
Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients [NCT00950261]Phase 20 participants (Actual)Interventional2009-01-31Withdrawn(stopped due to A competing trial has been initiated.)
"Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma (Basal Like)" [NCT00463788]Phase 2181 participants (Actual)Interventional2007-06-30Completed
Induction Chemotherapy (IC) With Paclitaxel and Cisplatin (PC) Followed by Concomitant Chemoradiotherapy (CCRT) in Patient With Advanced Squamous Carcinoma of the Head and Neck (SSCHN). [NCT00959387]Phase 260 participants (Actual)Interventional2009-08-31Completed
A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00547157]Phase 2152 participants (Actual)Interventional2007-11-30Completed
A Phase I Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology [NCT03330028]Phase 129 participants (Actual)Interventional2017-10-27Completed
A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Ne [NCT00989651]Phase 1431 participants (Actual)Interventional2009-10-28Completed
Phase Ib/II Study of the Gamma-Secretase Inhibitor (GSI) RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma [NCT01196416]Phase 1/Phase 214 participants (Actual)Interventional2010-08-31Completed
[NCT02142010]67 participants (Anticipated)Interventional2014-08-31Recruiting
Toripalimab With Paclitaxel and Cisplatin as Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma [NCT04804696]Phase 253 participants (Anticipated)Interventional2021-02-10Recruiting
A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Sma [NCT03164616]Phase 31,186 participants (Actual)Interventional2017-06-01Active, not recruiting
Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma [NCT00577096]120 participants (Actual)Interventional2001-10-31Completed
Randomized Phase 3 Trial of Triple Combination of Induction, Concurrent and Adjuvant Chemotherapy Versus Concurrent Chemotherapy Alone in High Risk Nasopharyngeal Carcinoma Patients Treated With Intensity-modulated Radiotherapy [NCT02621970]Phase 3534 participants (Anticipated)Interventional2016-01-31Not yet recruiting
A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer [NCT00622349]Phase 3707 participants (Actual)Interventional2004-02-29Completed
A Phase 2 Randomized Study of the BER Inhibitor TRC102 in Combination With Standard Pemetrexed-Platinum-Radiation in Stage III Non-Squamous Non-Small Cell Lung Cancer [NCT05198830]Phase 278 participants (Anticipated)Interventional2022-12-15Recruiting
A Phase I Adaptive Design Trial of Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors [NCT02537561]Phase 10 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to The pharmaceutical company did not want to follow through with support for the study.)
An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer [NCT05500092]Phase 252 participants (Anticipated)Interventional2023-01-25Recruiting
A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients [NCT00916500]Phase 271 participants (Actual)Interventional2006-03-31Completed
A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer [NCT01401192]Phase 2304 participants (Anticipated)Interventional2011-07-31Recruiting
A Phase Ib, Multi-centre, Open-label Study of a First-in-class Nucleotide Analogue Acelarin (NUC-1031) in Combination With Cisplatin in Patients With Locally Advanced/Metastatic Biliary Tract Cancers [NCT02351765]Phase 121 participants (Actual)Interventional2016-01-31Completed
Prospective Non-inferiority Randomized Trial Comparing Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation and Traditional Clinical Target Volume in Radiotherapy for Nasopharyngeal Carcinoma [NCT02627807]386 participants (Actual)Interventional2015-12-31Active, not recruiting
Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Cilengitide Regimens in Combination With Cetuximab and Platinum-based Chemotherapy (Cisplatin/Vinorelbine or Cisplatin/Gemcitabine) Compared to Cetuximab and Platinum-based Che [NCT00842712]Phase 2232 participants (Actual)Interventional2009-02-28Completed
An Open Label Phase 1 Study to Assess the Maximum Tolerated Dose of ZACTIMAâ„¢ Given Concomitantly With Weekly Cisplatin Chemotherapy and Radiation Therapy in Patients With Previously Untreated, Unresected Stage III-IV Head and Neck Squamous Cell Carcinoma [NCT00450138]Phase 148 participants (Actual)Interventional2006-12-31Completed
An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer [NCT00759226]Phase 292 participants (Actual)Interventional2002-07-31Completed
A Pilot Study of Heated Intraperitoneal Chemotherapy (HIPEC) After Interval Cytoreductive Surgery (CRS) in Patients Who Have Received Neoadjuvant Chemotherapy (NACT) for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers [NCT03540017]Phase 115 participants (Anticipated)Interventional2019-03-12Recruiting
Trial to Determine the CR Rate at the Primary Tumor Site After 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head & Neck Carcinoma Treated With Definitive Concurrent Cisplatin & Radiation Therapy [NCT00736944]Phase 230 participants (Actual)Interventional2008-12-19Completed
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009) [NCT02624531]60 participants (Anticipated)Interventional2015-11-30Recruiting
An Individualized Cancer Vaccine for Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT02624999]Phase 20 participants (Actual)Interventional2016-12-31Withdrawn(stopped due to PI changed institution)
Phase Ib Trial of Dose-escalating AZD1775 in Combination With Concurrent Radiation and Cisplatin for Intermediate and High Risk Head and Neck Squamous Cell Carcinoma (HNSCC) [NCT02585973]Phase 112 participants (Actual)Interventional2015-10-26Completed
MK-0646 IMPACT Study: MK-0646, Insulin Growth Factor 1 Receptor Antibody in Stage IIIB or IV Metastatic Non-Squamous Lung Cancer, Combined With Pemetrexed (Alimta) and Cisplatin, a Randomized Phase II Trial. [NCT00799240]Phase 227 participants (Actual)Interventional2009-06-30Completed
A Multicentre, Randomised, Phase III Trial of Platinum-based Chemotherapy Versus Non-platinum Chemotherapy, After ERCC1 Stratification, in Patients With Advanced/Metastatic Non-small Cell Lung Cancer [NCT00801736]Phase 3648 participants (Actual)Interventional2009-10-31Terminated(stopped due to The antibody used did not appear prognostic/predictive based on interim results.)
An Prospective, Multicenter, Double-blind, Randomized, Controlled Clinical Study of Nimotuzumab Combined With Paclitaxel and Cisplatin as First-line Treatment of Metastatic Esophageal Squamous Cell Carcinomas [NCT02611700]Phase 3504 participants (Anticipated)Interventional2015-11-30Recruiting
Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer [NCT02607540]Phase 3210 participants (Anticipated)Interventional2014-10-31Recruiting
Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer [NCT02595554]Phase 3220 participants (Anticipated)Interventional2015-11-30Recruiting
A Phase 1/2 Study of the Bromodomain Inhibitor Molibresib in Combination With Etoposide/Platinum in Patients With NUT Carcinoma [NCT04116359]Phase 1/Phase 20 participants (Actual)Interventional2020-09-18Withdrawn(stopped due to Other - Protocol moved to Disapproved)
Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma: a Single Arm, Multicentre Trial. [NCT04063683]Phase 247 participants (Actual)Interventional2019-10-07Active, not recruiting
Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers: a Prospective, Open Label, Single-arm Phase II Trial [NCT04111380]Phase 230 participants (Anticipated)Interventional2019-09-24Recruiting
A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation [NCT01683175]Phase 294 participants (Actual)Interventional2012-08-31Active, not recruiting
A Study of Stereotactic Body Radiation Therapy (SBRT) in Combination With Cisplatin Transcatheter Arterial Chemoembolization (TACE) for Primary Hepatocellular Carcinoma (HCC) [NCT00746655]0 participants (Actual)Interventional2009-07-31Withdrawn(stopped due to Unable to recruit)
Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer: A Randomized, Controlled, Multicenter Phase II Clinical [NCT04300959]Phase 280 participants (Anticipated)Interventional2020-01-01Recruiting
A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT) [NCT00785421]Phase 2/Phase 3312 participants (Actual)Interventional2004-04-30Completed
An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma [NCT02677597]Phase 3268 participants (Anticipated)Interventional2016-01-31Recruiting
Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma:: A Phase 3 Trial [NCT03919552]Phase 3482 participants (Anticipated)Interventional2018-01-31Recruiting
Phase II Single-Arm Trial Comparing the Use of FLT PET to Standard Computed Tomography to Assess the Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable Non-small Cell Lung Cancer [NCT00963807]Phase 226 participants (Actual)Interventional2009-09-30Completed
Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine [NCT02648425]Phase 131 participants (Actual)Interventional2014-08-05Completed
Phase Ib Trial of Pembrolizumab (MK-3475) With Platinum-Based Chemotherapy in Small Cell/Neuroendocrine Cancers of Urothelium and Prostate [NCT03582475]Phase 115 participants (Actual)Interventional2018-12-20Completed
A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma [NCT00554788]Phase 360 participants (Actual)Interventional2008-02-04Active, not recruiting
Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepat [NCT02807181]Phase 2/Phase 389 participants (Actual)Interventional2017-01-31Completed
A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer [NCT00845884]Phase 1/Phase 249 participants (Anticipated)Interventional2009-02-28Not yet recruiting
A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable L [NCT04187352]Phase 3540 participants (Actual)Interventional2019-12-19Completed
Intraoperative Intraperitoneal Chemoperfusion to Treat Peritoneal Minimal Residual Disease in Stage III Ovarian Cancer: A Randomized Phase II Trial [NCT02567253]Phase 256 participants (Actual)Interventional2016-03-31Completed
A Phase I Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in Locally Advanced Squamous Cell Carcinoma of Head and Neck (HNSCC) [NCT00882583]Phase 122 participants (Actual)Interventional2009-07-31Terminated(stopped due to Low accrual)
Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck [NCT00639769]Phase 241 participants (Actual)Interventional2002-02-28Completed
Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs. Concomitant Radiotherapy And Chemotherapy In FIGO Ib2, IIa>4 cm or IIb Cervical Cancer [NCT00039338]Phase 3686 participants (Anticipated)Interventional2002-03-31Active, not recruiting
A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer. [NCT00633568]Phase 3125 participants (Actual)Interventional2007-01-31Terminated(stopped due to Slow recruitment)
[NCT02795884]Phase 30 participants (Actual)Interventional2016-06-30Withdrawn(stopped due to Because of reconsideration of using erlotinib(EGFR Tyrosine kinase inhibitor) as adjuvant aim)
Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer [NCT01091454]Phase 248 participants (Actual)Interventional2010-06-30Completed
Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan [NCT02777788]Phase 2/Phase 3120 participants (Anticipated)Interventional2014-09-30Active, not recruiting
Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer [NCT00907504]Phase 30 participants (Actual)Interventional2010-07-31Withdrawn
A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma [NCT00942357]Phase 3813 participants (Actual)Interventional2009-06-29Active, not recruiting
A Phase Ib Trial of Intraperitoneal Cisplatin and Nab-paclitaxel Administered by Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in the Treatment of Advanced Malignancies Confined to the Peritoneal Cavity [NCT04000906]Phase 136 participants (Anticipated)Interventional2020-11-11Recruiting
AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA [NCT01055496]Phase 1103 participants (Actual)Interventional2010-03-31Completed
A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer [NCT00193921]Phase 282 participants (Actual)Interventional2003-02-28Completed
Phase 1 Study of Ixabepilone in Combination With Cisplatin in Subjects With Advanced Solid Tumors [NCT00832117]Phase 130 participants (Actual)Interventional2009-05-31Completed
Pilot Study of the Feasibility of Intrapleural Photodynamic Therapy in a Multimodal Treatment Combining Extended Pleurectomy/Decortication, Adjuvant Chemotherapy and Prophylactic Radiotherapy in Patients With Malignant Pleural Mesothelioma [NCT02662504]Phase 26 participants (Actual)Interventional2016-01-16Completed
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity: A Phase I Trial [NCT00942838]Phase 10 participants (Actual)Interventional2009-07-31Withdrawn(stopped due to PI decision due to under accrual.)
Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) Chemotherapy Plus Cisplatin (or Carboplatin) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type [NCT02906150]Phase 2140 participants (Anticipated)Interventional2016-09-30Not yet recruiting
Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck [NCT00868491]Phase 230 participants (Anticipated)Interventional2008-03-31Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma [NCT01697072]Phase 3609 participants (Actual)Interventional2012-10-31Terminated(stopped due to All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.)
A Pilot Induction Regimen Incorporating Chimeric 14.18 Antibody (ch14.18, Dinutuximab) (NSC# 764038) and Sargramostim (GM-CSF) for the Treatment of Newly Diagnosed High-Risk Neuroblastoma [NCT03786783]Phase 242 participants (Actual)Interventional2019-01-14Active, not recruiting
A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 With Concurrent Cisplatin and Radiation Therapy in Subjects With Locally Advanced Head and Neck Cancer [NCT01384799]Phase 112 participants (Actual)Interventional2011-11-30Completed
Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC) [NCT04329494]Phase 149 participants (Anticipated)Interventional2020-08-21Recruiting
The Study of Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for Patient With the Advanced Non-small Cell Lung Cancer( NSCLC) [NCT01393080]160 participants (Anticipated)Interventional2011-03-31Recruiting
A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01479504]Phase 32 participants (Anticipated)Interventional2011-11-30Recruiting
A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047) [NCT04221945]Phase 3980 participants (Anticipated)Interventional2020-05-12Active, not recruiting
Effectiveness of RaproCell in Alleviating the Side Effects of Chemotherapeutic Agents, Without Adversely Impacting the Overall Success of the Agents on Cancer Cells. [NCT05137067]Phase 290 participants (Actual)Interventional2021-01-20Completed
IPI-Biochemotherapy for Chemonaive Patients With Metastatic Melanoma [NCT01409174]Phase 119 participants (Actual)Interventional2013-02-28Terminated(stopped due to Slow accrual, closed in Phase I.)
A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras [NCT01410214]Phase 280 participants (Anticipated)Interventional2011-05-31Recruiting
Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer [NCT04311762]Phase 19 participants (Anticipated)Interventional2020-02-26Recruiting
Phase II Study Evaluating Combination Chemotherapy + Radiotherapy (RT) With Avelumab in Muscle Invasive Bladder Cancer [NCT03617913]Phase 22 participants (Actual)Interventional2018-09-19Completed
Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma [NCT00970996]Phase 110 participants (Actual)Interventional2009-09-30Completed
A Feasibility and Phase II Study of Proton Beam Radiotherapy for Patients With Cervical Cancer and FDG-PET Positive Para-aortic Lymph Nodes [NCT01019278]Phase 20 participants (Actual)Interventional2009-07-31Withdrawn
Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer [NCT00143455]Phase 3485 participants (Actual)Interventional2002-06-30Completed
A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer [NCT03535727]Phase 1/Phase 286 participants (Anticipated)Interventional2018-06-21Recruiting
A Phase II Trial of Neoadjuvant AGEN1884 Plus AGEN2034 in Combination With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Prior to Radical Cystectomy [NCT04430036]Phase 24 participants (Actual)Interventional2020-10-14Active, not recruiting
Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma [NCT00567567]Phase 3665 participants (Actual)Interventional2007-11-05Completed
Chemoembolization for Hepatocellular Carcinoma [NCT02821533]Phase 224 participants (Actual)Interventional2012-02-29Terminated(stopped due to Poor case accrual)
A Randomized Trial of Adding Bevacizumab to Neoadjuvant Platinum-Fluorouracil Concurrent Chemoradiation in Locally Advanced Esophageal Squamous Cell Carcinoma [NCT02812641]Phase 250 participants (Anticipated)Interventional2016-06-30Recruiting
A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation [NCT05800574]Phase 222 participants (Anticipated)Interventional2023-03-14Recruiting
Phase I/II Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma [NCT02801487]Phase 1/Phase 26 participants (Actual)Interventional2015-09-30Terminated(stopped due to Slow accrual of patients.)
Phase Ib/II Study Assessing the Neo-adjuvant Combination Therapy of Vinflunine With Cisplatin Followed by Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer (JaNEO) [NCT02845050]Phase 1/Phase 20 participants (Actual)Interventional2016-07-31Withdrawn(stopped due to No participants found)
Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma: a Prospective Non-randomized Trial [NCT02755311]Phase 3198 participants (Anticipated)Interventional2014-03-31Recruiting
Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With Intensity-modulated Radiotherapy in High Risk Locregionally Advanced Nasopharyngeal Carcinoma: a Phase 2 Randomized Controlled Trial [NCT02610556]Phase 2130 participants (Anticipated)Interventional2016-01-31Recruiting
A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day 1 Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma [NCT00814086]Phase 123 participants (Actual)Interventional2009-02-28Completed
A Pilot/ Feasibility Study Comparing Response Rates of Intra-arterial and Intravenous Cisplatin Chemotherapy, Combined With Radiation, in Patients With Locally Advanced Carcinoma of the Oral Cavity and Oropharynx [NCT01587820]Early Phase 11 participants (Actual)Interventional2012-06-30Terminated(stopped due to lack of enrollment)
Prospectively Randomized Phase III Study of an Individualized Sensitivity-Directed Combination Chemotherapy Versus DTIC as First-Line Treatment in Stage IV Metastatic Melanoma [NCT00779714]Phase 3360 participants (Anticipated)Interventional2008-10-31Recruiting
Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma: a Phase 3 Non-inferior Multicenter Randomized Controlled Trial [NCT02610010]Phase 3462 participants (Anticipated)Interventional2015-11-30Recruiting
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin [NCT00999700]Phase 3282 participants (Anticipated)Interventional2009-09-30Active, not recruiting
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma [NCT04924062]Phase 3158 participants (Actual)Interventional2020-07-10Active, not recruiting
Phase I Study of Induction Cisplatin, Docetaxel, and Nintedanib for Stage IB-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection [NCT02225405]Phase 126 participants (Actual)Interventional2015-04-03Active, not recruiting
PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study [NCT04115410]4,724 participants (Anticipated)Observational2020-07-01Not yet recruiting
Feasibility, Efficacy and Safety of Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) With Oxaliplatin, Cisplatin and Doxorubicin in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancers and Primary Tumors of the Perito [NCT02604784]Phase 1/Phase 2105 participants (Actual)Interventional2015-10-31Completed
A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM) [NCT00651456]Phase 2/Phase 3448 participants (Actual)Interventional2008-02-29Completed
Efficacy and Safety of Rh-endostatin(Endostar)Combined With Platinum-based Doublet Chemotherapy and Pembrolizumab as First Line Therapy in Patients With Advanced or Metastatic Non-small-cell Lung Cancer [NCT04094909]Phase 2186 participants (Anticipated)Interventional2020-02-06Not yet recruiting
Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer [NCT05313906]Phase 240 participants (Anticipated)Interventional2022-05-07Not yet recruiting
Combined Stereotactic Radiotherapy and Conventional Fractionation in Stage II and III Non Small Cell Lung Cancer (NSCLC) With Peripheral Tumors Smaller Than 5 cm [NCT01933568]Phase 115 participants (Actual)Interventional2013-02-28Completed
Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC [NCT01993810]Phase 3330 participants (Actual)Interventional2014-02-03Active, not recruiting
Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer [NCT01069081]Phase 294 participants (Actual)Interventional2009-08-31Completed
Role of Early 18F-FDG-PET/CT Scan in Predicting Mediastinal Downstaging With Neoadjuvant Chemotherapy in Resectable Stage III A NSCLC [NCT02607423]Phase 20 participants (Actual)Interventional2015-11-19Withdrawn(stopped due to The study failed to meet its accrual targets.)
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial [NCT05076942]Phase 2157 participants (Anticipated)Interventional2021-01-01Recruiting
UARK 2006-15: A Phase III Randomized Study of Tandem Transplants With or Without Bortezomib (Velcade) and Thalidomide (Thalomid) to Evaluate Its Effect on Response Rate and Durability of Response in Multiple Myeloma Patients [NCT00574080]Phase 320 participants (Actual)Interventional2006-07-31Terminated(stopped due to low accrual)
A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer [NCT00006027]Phase 30 participants Interventional2000-08-31Completed
A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes [NCT00006096]Phase 30 participants Interventional2001-03-31Terminated
A Randomized,Double-blind,Controlled,Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer [NCT05179239]Phase 3572 participants (Anticipated)Interventional2022-02-26Recruiting
A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma [NCT00262951]Phase 223 participants (Actual)Interventional2005-01-31Terminated(stopped due to Closed at a planned interim analysis by meeting a predefined toxicity endpoint)
Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis [NCT00001332]Phase 150 participants Interventional1992-12-31Completed
Phase I Study of TTC (Taxotere/Temodar/Cisplatin) in Metastatic Melanoma Patients [NCT00527761]Phase 123 participants (Actual)Interventional2004-08-31Completed
Pilot Study of Gemcitabine and Cisplatin Plus AGS-003-BLD in Patients With Muscle-Invasive Bladder Cancer Undergoing Neoadjuvant Cisplatin-Based Chemotherapy [NCT02944357]0 participants (Actual)Interventional2016-11-30Withdrawn
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer [NCT00123318]Phase 352 participants (Actual)Interventional2003-02-28Completed
A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer [NCT00148694]Phase 227 participants (Actual)Interventional2004-07-31Completed
A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma [NCT00818090]Phase 239 participants (Actual)Interventional2008-09-30Terminated(stopped due to marginal statistical significance)
The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC,A Single-arm Study [NCT05469061]Phase 217 participants (Anticipated)Interventional2022-01-01Recruiting
A Randomized Phase II Trial of Strontium-89 With or Without Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer [NCT00156884]Phase 258 participants (Anticipated)Interventional2003-08-31Completed
Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma [NCT00158678]Phase 3310 participants (Anticipated)Interventional2005-09-27Completed
A Phase II Trial of Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma [NCT04006041]Phase 244 participants (Anticipated)Interventional2019-06-25Recruiting
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer [NCT00320359]Phase 3700 participants (Actual)Interventional2002-08-31Completed
The Efficacy and Safety of Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil, Concurrent Chemotherapy of Cisplatin and IMRT in Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multi-centeric, Open, Non-controlled, Phas [NCT04004871]Phase 260 participants (Anticipated)Interventional2019-07-05Not yet recruiting
A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00720083]Phase 234 participants (Actual)Interventional2008-11-30Terminated(stopped due to Withdrawal of drug supply.)
A Randomized Controlled Trial of Chemotherapy With 5FU and Cisplatin Before and After Surgery for Stage II,III Squamous Cell Carcinoma of the Thoracic Esophagus:JCOG9907 [NCT00190554]Phase 3330 participants Interventional2000-05-31Terminated
Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma [NCT01000415]Phase 3824 participants (Anticipated)Interventional2009-06-30Recruiting
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors [NCT01040312]321 participants (Actual)Observational2009-10-15Completed
A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer [NCT00388154]Phase 221 participants (Actual)Interventional2004-08-31Completed
A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA [NCT00369122]Phase 260 participants (Actual)Interventional2006-08-11Completed
PARP Inhibition After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer or ER/PR +, HER2 Negative With Known BRCA1/2 Mutations: Hoosier Oncology Group BRE09-146 [NCT01074970]Phase 2135 participants (Actual)Interventional2010-02-28Completed
Phase II Study of Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib [NCT05948462]Phase 20 participants (Actual)Interventional2023-11-30Withdrawn(stopped due to Study withdrawn by pharmaceutical funding partner)
An Open-label Window of Opportunity Trial to Evaluate the Activity of Durvalumab (MEDI4736) and Tremelimumab With Platinum-based Chemotherapy (Gemcitabine and Cisplatin) in Intrahepatic Cholangiocarcinoma (ICC) [NCT04989218]Phase 1/Phase 220 participants (Anticipated)Interventional2023-01-30Recruiting
Phase II Study in Operable Adenocarcinoma of the Esophagus to Measure Response Rate and Toxicity of Preoperative Combined Modality Paclitaxel (Taxol®, Bristol-Myers Squibb), Cisplatin (Platinol®, Abbott Laboratories), ZD1839 (IRESSA®) and Radiotherapy Fol [NCT00493025]Phase 219 participants (Actual)Interventional2005-04-30Terminated(stopped due to Closed due to early stopping rule-Low accrual)
A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma [NCT00331760]Phase 2106 participants (Actual)Interventional2006-03-31Completed
A Phase I Trial Using RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer [NCT01058408]Phase 13 participants (Actual)Interventional2010-02-28Terminated
DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer [NCT03981068]20 participants (Anticipated)Interventional2019-09-01Recruiting
A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma [NCT02532192]Phase 10 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Withdrawal of study support.)
Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix [NCT00770874]Phase 3375 participants (Actual)Interventional2008-09-30Completed
Neoadjuvant Docetaxel+Cisplatin and 5-fluorouracil (TPF) Followed by Radiotherapy+Concomitant Chemo or Cetuximab Versus Radiotherapy+Concomitant Chemo or Cetuximab in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. A Randomize [NCT01086826]Phase 3320 participants (Actual)Interventional2008-03-31Completed
An Evaluation of Preoperative Chemotherapy With Irinotecan and Cisplatin for Advanced, But Resectable Gastric Cancer: A Coordinated Multidisciplinary, Multicenter Study Linking Functional Imaging, Genomic Expression Profiles and Histopathology [NCT00062374]Phase 255 participants (Actual)Interventional2003-06-30Completed
Phase Ib Study of Pembrolizumab in Combination With Chemo Radiotherapy (CRT) for Locally-advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT02586207]Phase 159 participants (Actual)Interventional2015-11-30Active, not recruiting
Immunotherapy With MK-3475 in Locoregionally Advanced, Surgically Resectable Head and Neck Squamous Cell Carcinoma [NCT02296684]Phase 267 participants (Actual)Interventional2015-03-25Active, not recruiting
Pilot Trial of Sirolimus, Gemcitabine and Cisplatin for Patients With High Risk for Cholangiocarcinoma Recurrence [NCT01888302]Phase 11 participants (Actual)Interventional2013-09-30Completed
A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-Induced Photochemical Internalisation (PCI) of Gemcitabine in Patients With Advanced Inoperable Cholangiocarcinomas [NCT01900158]Phase 124 participants (Actual)Interventional2013-05-31Completed
Preconditioning Chemotherapy Combined With Cytokine Induced Killer Cell Immunotherapy in Advanced Non Small Cell Lung Cancer [NCT01902875]100 participants (Anticipated)Observational2013-06-30Recruiting
The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer [NCT01917617]Phase 250 participants (Actual)Interventional2013-05-22Completed
A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer [NCT01918124]Phase 280 participants (Anticipated)Interventional2008-01-31Completed
Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation [NCT00209222]Phase 3360 participants (Anticipated)Interventional2004-07-31Recruiting
Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer. [NCT00209690]Phase 1/Phase 230 participants (Anticipated)Interventional2003-10-31Completed
Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma [NCT01947062]Phase 360 participants (Anticipated)Interventional2013-10-31Not yet recruiting
Multicenter Phase II Study of Pemetrexed/Cisplatin With or Without Bevacizumab in Patients With Brain Metastases From Non Squamous Non-small Cell Lung Cancer Harboring EGFR Wild Type [NCT01951482]Phase 2108 participants (Anticipated)Interventional2013-06-30Recruiting
Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery Followed by Risk-Based IMRT and Weekly Cisplatin Versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer [NCT01953952]Phase 20 participants (Actual)Interventional2013-12-31Withdrawn(stopped due to Slow accrual)
A Randomized Registry Trial of Adjuvant Mitotane vs. Mitotane With Cisplatin/Etoposide After Primary Surgical Resection of Localized Adrenocortical Carcinoma With High Risk of Recurrence (ADIUVO-2 Trial) [NCT03583710]Phase 3240 participants (Anticipated)Interventional2018-08-20Recruiting
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Advanced Solid Tumors [NCT01980667]Phase 141 participants (Actual)Interventional2014-07-30Completed
HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or [NCT02875314]Phase 4250 participants (Anticipated)Interventional2015-09-30Recruiting
A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer [NCT01993979]Phase 3261 participants (Actual)Interventional2012-05-31Active, not recruiting
Apatinib Mesylate Combined With Albumin Binds Paclitaxel and Carboplatin or Cisplatinum as First-line Treatment for Stage II-IV Epithelial Ovarian Cancer Followed by Apatinib Maintenance Therapy:a Single-arm,Exploratory Clinical Study [NCT04590625]Phase 258 participants (Anticipated)Interventional2020-10-31Recruiting
A Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity. [NCT04588090]200 participants (Anticipated)Interventional2016-01-01Active, not recruiting
Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer [NCT01999933]Phase 2/Phase 3600 participants (Anticipated)Interventional2013-11-30Recruiting
Comparison of Postoperative Adjuvant Chemotherapy With/Without Rh-endostatin: a Randomized, Phaseâ…¢ and Open Clinical Study of Non-small Cell Lung Cancer in Phaseâ… B [NCT02001168]Phase 3392 participants (Anticipated)Interventional2013-10-31Active, not recruiting
A Single-arm Prospective Clinical Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin for the Neoadjuvant Treatment of Biliary Tract Malignancies [NCT06181032]Phase 135 participants (Anticipated)Interventional2023-12-23Not yet recruiting
Randomized, Placebo-controlled, Double-blind Phase II Clinical Trial of Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab Immunotherapy Combined With Concurrent Chemoradiotherapy for High-risk Nasopharyngeal Carcinoma [NCT03925090]Phase 2150 participants (Anticipated)Interventional2019-12-08Active, not recruiting
Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma Based on HPV Subtype and Plasma Circulating Free HPV DNA Level and Clearance Rate [NCT05268614]Phase 2250 participants (Anticipated)Interventional2022-05-05Recruiting
A Single-Arm Phase 2 Study to Investigate Bintrafusp Alfa With Platinum-Pemetrexed for TKI-Resistant EGFR-Mutant NSCLC [NCT04971187]Phase 23 participants (Actual)Interventional2021-06-30Terminated(stopped due to PI Request)
A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy [NCT02445391]Phase 3415 participants (Actual)Interventional2015-10-20Active, not recruiting
Sequential Paclitaxel Plus Cisplatin Chemotherapy and Radiotherapy as First Line Treatment for Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial [NCT02016274]Phase 270 participants (Anticipated)Interventional2013-12-31Recruiting
A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients With High Grade Upper Tract Urothelial Carcinoma [NCT02412670]Phase 236 participants (Actual)Interventional2015-08-27Completed
Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer [NCT00008112]Phase 20 participants Interventional2000-06-30Active, not recruiting
Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Node-positive Thoracic Esophageal Squamous Cell Carcinoma: a One-arm, Phase II Clinical Study [NCT05637268]Phase 223 participants (Anticipated)Interventional2020-11-26Recruiting
A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors [NCT01220583]Phase 2252 participants (Actual)Interventional2011-01-31Active, not recruiting
A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features [NCT04671667]Phase 2188 participants (Anticipated)Interventional2021-04-27Recruiting
Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO) [NCT04267848]Phase 31,210 participants (Anticipated)Interventional2020-06-16Recruiting
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) [NCT02194738]8,300 participants (Anticipated)Interventional2014-09-26Recruiting
A Phase 1 Study of RAD001 in Combination w/ Cetuximab and Cisplatin as First-line Therapy in Recurrent & Metastatic Squamous Cell Cancer of the Head & Neck [NCT01009346]Phase 1/Phase 29 participants (Actual)Interventional2009-10-31Terminated(stopped due to Toxicity)
Neoadjuvant Immunotherapy Combined With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Cancer: an Open Label, Randomized Control, Phase II Trial [NCT04625543]Phase 20 participants (Actual)Interventional2020-12-31Withdrawn(stopped due to insufficient money)
A Phase II Single-arm Study of Tazemetostat With Docetaxel, Cisplatin, and 5-fluorouracil as Preoperative Treatment for Locally Advanced Potentially Resectable SMARCB1 (INI-1)- Deficient Sinonasal Carcinoma [NCT05151588]Phase 230 participants (Anticipated)Interventional2023-09-01Not yet recruiting
A Randomized Study of Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation Therapy in Stage III Unresectable NSCLC [NCT00191139]Phase 264 participants (Actual)Interventional2003-03-31Completed
Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin [NCT02667925]0 participants (Actual)Interventional2016-03-31Withdrawn(stopped due to Because of the obsolescence of the study)
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients [NCT04544969]50 participants (Anticipated)Observational [Patient Registry]2020-04-01Recruiting
A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Study [NCT06048926]30 participants (Anticipated)Interventional2022-07-30Enrolling by invitation
A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial [NCT05753306]Phase 220 participants (Anticipated)Interventional2023-03-16Recruiting
Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer [NCT05624996]Phase 3474 participants (Anticipated)Interventional2023-05-10Recruiting
A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Tislelizumab in the Treatment of Malignancies [NCT05516914]Phase 1/Phase 2490 participants (Anticipated)Interventional2022-09-01Recruiting
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation [NCT05118854]Phase 227 participants (Anticipated)Interventional2022-03-30Recruiting
Randomized Phase II/III Trial of Radiation With High-Dose Cisplatin (100 mg/m2) Every Three Weeks Versus Radiation With Low-Dose Weekly Cisplatin (40 mg/m2) for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT05050162]Phase 2/Phase 3464 participants (Anticipated)Interventional2021-10-27Recruiting
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently With Platinum-based Chemoradiation Therapy in Patients With Locally Advanced, Unresectable NSCLC (Stage III) (PACIFIC2) [NCT03519971]Phase 3328 participants (Actual)Interventional2018-03-29Active, not recruiting
Phase III Randomized Trial of Immunotherapy With or Without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma [NCT05721755]Phase 3290 participants (Anticipated)Interventional2023-06-08Recruiting
A Phase I Trial of the Hypoxia Modifier Atovaquone in Combination With Radical Concurrent Chemoradiotherapy in Locally Advanced Non-Small Cell Lung Cancer [NCT04648033]Phase 121 participants (Actual)Interventional2020-12-07Completed
An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the [NCT02741570]Phase 3947 participants (Actual)Interventional2016-10-05Completed
Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma and/or Poorly Differentiated Carcinoma of the Nasal Cavity and/or Paranasal Sinuses [NCT00707473]Phase 231 participants (Actual)Interventional2008-06-16Active, not recruiting
Multicenter Phase II Study of Weekly Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Squamous Cell Cancer of the Head and Neck [NCT01645748]Phase 235 participants (Actual)Interventional2008-10-31Completed
Effect of Oral Nutritional Supplements From the Beginning of Radiotherapy on Body Weight Loss of Patients With Nasopharyngeal Carcinoma and Its Cost-effectiveness Analysis: A Prospective Multicenter Randomized Controlled Trial [NCT04823468]214 participants (Anticipated)Interventional2021-07-19Recruiting
A Trial Comparing Pre-operative Chemo-radiotherapy With Cisplatin and Fluorouracil Versus Chemotherapy With Docetaxel and Irinotecan in PET Non Responders Resectable Cancer Esophagus: a Multicenter Study [NCT01608464]Phase 2170 participants (Actual)Interventional2012-05-31Terminated(stopped due to poor accrual)
A Prospective Open Label Phase II Study to Optimize the Dose in 3D Pulsed Dose Rate Brachytherapy in Patients With Locally Advanced Cervical Cancer [NCT02880007]Phase 248 participants (Actual)Interventional2011-06-06Completed
Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer [NCT02879227]Phase 223 participants (Actual)Interventional2010-01-31Completed
A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus [NCT02586753]Phase 22 participants (Anticipated)Interventional2015-12-31Not yet recruiting
Safety of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Biliary Tract Cancer Patients With Peritoneal Metastases [NCT05285358]Phase 112 participants (Anticipated)Interventional2022-09-19Recruiting
Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Concomitant Treatment With Cisplatin and Radiotherapy Versus Concomitant Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer. [NCT00716391]Phase 3519 participants (Actual)Interventional2008-07-07Completed
TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial [NCT02940925]Phase 3241 participants (Actual)Interventional2016-10-20Completed
A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer [NCT00717938]Phase 3390 participants (Actual)Interventional2008-06-30Completed
A Phase II Trial of Xevinapant in Combination With Post-Operative Cisplatin and Radiotherapy for High Risk Head and Neck Cancer [NCT06145412]Phase 254 participants (Anticipated)Interventional2023-11-16Recruiting
Phase II Study of Induction Checkpoint Blockade for Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection [NCT03158129]Phase 2101 participants (Actual)Interventional2017-06-09Active, not recruiting
Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial [NCT00778908]Phase 2/Phase 3120 participants (Actual)Interventional2008-01-31Completed
Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer. [NCT03649048]100 participants (Anticipated)Interventional2018-11-05Recruiting
A Single-arm Phase II Study of Chemoradiotherapy Plus Pembrolizumab as Adjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma Patients at High Risk of Recurrence Following Preoperative Chemoradiotherapy Plus Surgery [NCT03322267]Phase 226 participants (Anticipated)Interventional2018-10-27Recruiting
a Prospective Random Study on the Efficacy and Safety of Bevacizumab in Untreated Patients With Locally Advanced Cervical Cancer [NCT04138992]Phase 2/Phase 3150 participants (Anticipated)Interventional2020-08-01Recruiting
Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT) [NCT04136886]Phase 3346 participants (Anticipated)Interventional2020-01-01Recruiting
Phase â…¡ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma [NCT00817258]Phase 237 participants (Anticipated)Interventional2007-01-31Recruiting
A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma [NCT00951496]Phase 31,560 participants (Actual)Interventional2009-08-11Completed
Phase II Study of Cisplatinum and Everolimus in Patients With Metastatic or Unresectable Neuroendocrine Carcinomas (NEC) of Extrapulmonary Origin [NCT02695459]Phase 239 participants (Actual)Interventional2016-03-30Active, not recruiting
Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer [NCT02703961]Phase 3598 participants (Anticipated)Interventional2016-02-29Recruiting
Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer [NCT00620971]Phase 277 participants (Actual)Interventional2008-01-31Completed
Phase II Neoadjuvant Trial of Sorafenib in Combination With Cisplatin Followed by Dose Dense Paclitaxel for ER-, PR-, Her2- (Triple Negative) Early-Stage Breast Cancer [NCT01194869]Phase 225 participants (Actual)Interventional2010-06-30Terminated(stopped due to Slow accrual, availability of other clinical options)
Clinical Study of Hydrochloride Anlotinib Combined With Concurrent Radiochemotherapy for Locally Advanced (Stage IB3 and IIA2-IVA) Cervical Cancer [NCT04772001]53 participants (Anticipated)Interventional2021-03-12Recruiting
Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer [NCT00617656]Phase 3400 participants (Actual)Interventional2008-02-29Terminated(stopped due to No safety reasons. Interim analysis shows that the hypothesis superiority of the experimental arm over the control arm- would not be confirmed.)
A Multi-Center Randomized Phase IB/II Study of Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04) [NCT04203160]Phase 1/Phase 278 participants (Anticipated)Interventional2020-06-23Recruiting
Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study [NCT02665702]Phase 276 participants (Anticipated)Interventional2016-01-31Recruiting
Selection of Chemoradiotherapy Based on Response to Induction Chemotherapy - a Phase II Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck [NCT01133678]Phase 250 participants (Actual)Interventional2010-05-04Terminated(stopped due to Primary endpoint reached futility boundary)
Toripalimab Combined With Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multi-center, Randomized Controlled Trial [NCT04907370]Phase 3540 participants (Actual)Interventional2021-08-01Active, not recruiting
PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial [NCT03691090]Phase 3596 participants (Actual)Interventional2018-12-03Completed
Chidamide Combined With Cisplatin for Relapsed or Metastatic Triple-negative Breast Cancer [NCT04192903]Phase 255 participants (Anticipated)Interventional2019-12-25Recruiting
To Investigate the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Local Advanced Cervical Squamous Cell Carcinoma [NCT04678791]286 participants (Anticipated)Interventional2020-12-31Not yet recruiting
A Phase Ib, Open-Label, Dose- Escalation Trial of ACY-1215 in Combination With Gemcitabine and Cisplatin in Patients With Unresectable or Metastatic Cholangiocarcinoma [NCT02856568]Phase 10 participants (Actual)Interventional2017-05-01Withdrawn(stopped due to Site dropped study)
Induction Chemotherapy of Docetaxel, Cisplatin and Xeloda in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma [NCT02786641]Phase 3235 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Phase I Study of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion With Cisplatin in Patients With Recurrent Ovarian Cancer [NCT01387399]Phase 19 participants (Anticipated)Interventional2011-06-30Active, not recruiting
A National, Multi Center, Randomized, Open-label, Phase II Trial of Erlotinib Versus Combination of GC as (Neo)Adjuvant Treatment in Stage IIIA-N2 NSCLC With Sensitizing EGFR Mutation in Exon 19 or 21(EMERGING) [NCT01407822]Phase 2/Phase 372 participants (Actual)Interventional2011-12-05Active, not recruiting
[NCT01488838]Phase 2120 participants (Actual)Interventional2011-11-30Completed
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial [NCT01414608]Phase 3926 participants (Actual)Interventional2012-01-09Completed
Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients [NCT01416961]Phase 10 participants (Actual)Interventional2011-08-31Withdrawn(stopped due to Neutron therapy has become unavailable)
Randomized Phase â…¡ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01417390]Phase 280 participants (Anticipated)Interventional2011-11-30Recruiting
Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer [NCT01424709]Phase 2120 participants (Anticipated)Interventional2010-12-31Active, not recruiting
SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors [NCT01424839]Phase 4400 participants (Anticipated)Interventional2011-10-31Recruiting
Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma [NCT01425736]Phase 291 participants (Actual)Interventional2009-01-31Completed
A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer [NCT04809103]Phase 110 participants (Anticipated)Interventional2021-03-08Recruiting
Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer [NCT01426646]Phase 2218 participants (Anticipated)Interventional2011-09-30Recruiting
Phase III Randomized Trial of Comparing CCRT vs. RT Alone for Cervical Cancer Patients Primarily Treated by Radiotherapy and With Clinically Defined Good-prognosis [NCT00846508]Phase 3208 participants (Anticipated)Interventional2009-02-28Enrolling by invitation
Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer [NCT04409860]120 participants (Anticipated)Interventional2020-05-26Recruiting
A Multi-Center and Randomized Control Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery as Treatment for Relapsed and Refractory Non-Small Cell Lung Cancer [NCT02889666]Phase 1500 participants (Anticipated)Interventional2008-01-31Recruiting
A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemotherapy Paclitaxel + Cisplatin Versus Surgery Alone for Stage IIA-IIIB Esophageal Squamous Cell Carcinoma [NCT02395705]Phase 3528 participants (Anticipated)Interventional2015-06-30Completed
A Phase 1b Study of Ficlatuzumab, Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Intermediate or High Risk, Previously Untreated, Locally Advanced Head and Neck Squamous Cell Carcinoma With Biomarker Correlatives [NCT02277184]Phase 11 participants (Actual)Interventional2015-09-30Terminated(stopped due to the investigator left the institution)
Phase III Randomized Trial of High Dose Chemoradiation and Systemic Chemotherapy vs Systemic Chemotherapy Alone in Patients With Unresectable Nonmetastatic Cholangiocarcinoma [NCT02773485]Phase 3155 participants (Anticipated)Interventional2015-05-31Recruiting
A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer [NCT00173888]Phase 215 participants (Actual)Interventional2003-07-31Completed
A Phase II Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer [NCT00798655]Phase 246 participants (Actual)Interventional2007-11-30Completed
Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study [NCT02818725]Phase 3133 participants (Actual)Interventional2010-06-30Completed
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer [NCT00150670]Phase 3300 participants Interventional2002-03-31Completed
Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy [NCT02844114]Phase 260 participants (Anticipated)Interventional2016-01-31Recruiting
A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors [NCT03564691]Phase 1442 participants (Anticipated)Interventional2018-07-11Active, not recruiting
Phase III Trial of 3-weekly vs. 5-weekly Schedule of S-1 Plus Cisplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer. [NCT00915382]Phase 3625 participants (Actual)Interventional2009-01-31Completed
A Randomized Controlled Study of Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy [NCT02875457]Phase 3100 participants (Anticipated)Interventional2016-09-30Not yet recruiting
Phase II Clinical Trial of Cisplatin + Gemcitabine in Combination With Mild, Fever-Range Whole-Body Hyperthermia to Treat Patients With Advanced, Inoperable Pancreatic Cancer [NCT00178763]Phase 236 participants (Anticipated)Interventional2003-09-30Recruiting
A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination With Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma [NCT05691478]Phase 2/Phase 31,122 participants (Anticipated)Interventional2023-03-03Suspended(stopped due to Scheduled Interim Monitoring)
A Phase II/III Trial of Chemotherapy + Cetuximab vs Chemotherapy + Bevacizumab vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent/Metastatic Head and Neck Cancers [NCT05063552]Phase 2/Phase 3430 participants (Anticipated)Interventional2023-03-13Recruiting
Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab [NCT03811002]Phase 3545 participants (Anticipated)Interventional2019-07-26Recruiting
Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer [NCT03775265]Phase 3475 participants (Anticipated)Interventional2019-06-03Recruiting
A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers [NCT01825603]Phase 117 participants (Actual)Interventional2013-04-09Completed
Phase I Study of Intravenous Triapine® (IND #68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies. [NCT00335998]Phase 124 participants (Actual)Interventional2006-03-31Completed
Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy [NCT04920344]Phase 215 participants (Actual)Interventional2021-07-19Active, not recruiting
Pembrolizumab and aMVAC Chemotherapy as Neoadjuvant Therapy in Non-Urothelial Histology Muscle-Invasive Bladder Cancer: A Pilot Trial [NCT04383743]Phase 217 participants (Anticipated)Interventional2020-11-24Recruiting
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study [NCT01854749]Phase 257 participants (Actual)Interventional2011-11-30Completed
Comparison of Every 3 Week Versus Weekly Cisplatin Concurrent With Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Correlation With Oxidative Stress Markers [NCT02994069]Phase 280 participants (Anticipated)Interventional2017-04-11Recruiting
GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer [NCT01859728]Phase 248 participants (Anticipated)Interventional2013-01-31Recruiting
Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01872962]Phase 3480 participants (Actual)Interventional2013-11-30Active, not recruiting
A Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer [NCT03838263]Phase 262 participants (Actual)Interventional2019-07-25Active, not recruiting
A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND # 6370) for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Radiation Ther [NCT00360971]Phase 321 participants (Actual)Interventional2006-07-31Terminated(stopped due to Due to positive preliminary results from other palifermin studies.)
"Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: The Minimalist Trial (MINT)" [NCT03621696]Phase 263 participants (Actual)Interventional2018-10-23Active, not recruiting
PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System [NCT05406856]30 participants (Anticipated)Interventional2022-05-02Recruiting
Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis [NCT00004547]Phase 2188 participants (Actual)Interventional2000-01-31Completed
A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma [NCT00942331]Phase 3506 participants (Actual)Interventional2009-07-15Completed
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer [NCT01683864]Phase 2/Phase 33 participants (Actual)Interventional2012-09-30Terminated(stopped due to Recruitment problems)
A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA [NCT00002568]Phase 3470 participants (Anticipated)Interventional1994-06-30Completed
A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma [NCT00004188]Phase 3495 participants (Actual)Interventional2001-02-28Completed
A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract [NCT00353015]Phase 221 participants (Actual)Interventional2003-03-31Completed
Phase II Study of Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer [NCT00995761]Phase 248 participants (Actual)Interventional2009-10-31Completed
A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer [NCT04517292]Phase 2160 participants (Anticipated)Interventional2020-10-08Not yet recruiting
A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC) [NCT01240590]Phase 1/Phase 227 participants (Actual)Interventional2011-01-26Completed
Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer [NCT02937519]Phase 2160 participants (Anticipated)Interventional2015-06-30Recruiting
A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma [NCT00524498]Phase 260 participants (Actual)Interventional2007-09-30Completed
p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial [NCT00525200]Phase 3170 participants (Actual)Interventional2007-06-30Completed
Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase [NCT02919462]Phase 22 participants (Actual)Interventional2016-03-31Terminated(stopped due to low recruitement rate)
Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma [NCT02913066]Phase 288 participants (Anticipated)Interventional2016-09-30Recruiting
Phase II Trial of Neoadjuvant[FEC100]/Cisplatin-Docetaxel ± Trastuzumab in Women With Over Expressed or Amplified Her2/Neu With Locally Advanced Breast Cancer [NCT00535509]285 participants (Actual)Interventional2007-06-30Completed
Pilot Study Targeting Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer As Part of Adjuvant Therapy and Preventive Strategy [NCT01209520]6 participants (Actual)Interventional2009-07-31Completed
An International Randomized Phase III Study of First-line Erlotinib Followed by Second-line Cisplatin + Gemcitabine Versus First-line Cisplatin + Gemcitabine Followed by Second-line Erlotinib in Advanced Non Small Cell Lung Cancer [NCT00349219]Phase 3760 participants (Actual)Interventional2006-12-31Completed
A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed F [NCT03775486]Phase 2401 participants (Actual)Interventional2018-12-21Active, not recruiting
A Phase II Study of Olaparib Plus Cediranib in Combination With Standard Therapy for Small Cell Lung Cancer [NCT02899728]Phase 29 participants (Actual)Interventional2018-03-30Terminated(stopped due to Inadequate accrual rate)
A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium [NCT00448643]Phase 112 participants (Actual)Interventional2002-05-31Completed
A Phase II Trial of Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer [NCT04224740]Phase 237 participants (Actual)Interventional2020-06-15Active, not recruiting
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) [NCT03765918]Phase 3704 participants (Anticipated)Interventional2018-12-17Active, not recruiting
Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC [NCT04585490]Phase 348 participants (Anticipated)Interventional2021-08-25Recruiting
Neoadjuvant Nivolumab Plus Paclitaxel/ Cisplatin- Chemo- Radiotherapy (Neo-NTP-CRT) Followed by Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) [NCT05130684]Phase 243 participants (Anticipated)Interventional2021-02-22Recruiting
Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer [NCT03308604]Phase 118 participants (Anticipated)Interventional2018-05-17Recruiting
A Phase II Study of Induction Chemotherapy Followed by Surgical Treatment in Locally Advanced Oropharyngeal And Supraglotic Cell Carcinoma [NCT02760667]Phase 220 participants (Actual)Interventional2015-06-30Active, not recruiting
A Prospective Clinical Study of Ruxolitinib Phosphate Tablets and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome. [NCT04999878]Phase 430 participants (Anticipated)Interventional2021-05-30Recruiting
Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First Line Treatment in Patients With Stage IV Non-squamous Non Small Cell Lung Cancer (NSCLC) [NCT00942825]Phase 2195 participants (Actual)Interventional2009-04-30Completed
A Phase Ib, Open-label, Dose Escalation Trial Investigating Different Doses and Schedules of Sym004 in Combination With Platinum-doublets in Subjects With Stage IV Non-small Cell Lung Cancer [NCT02083679]Phase 115 participants (Actual)Interventional2014-07-31Terminated(stopped due to Sponsor the return rights of the compound to the collaboration partner for further clinical development)
A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer [NCT00076310]Phase 250 participants (Actual)Interventional2004-01-28Active, not recruiting
A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas [NCT00005088]Phase 20 participants Interventional2000-04-30Completed
A Phase I Study of CBLB502 in the Treatment of Patients With Poor Prognosis Advanced Squamous Cell Carcinomas of the Head and Neck Receiving Chemoradiotherapy [NCT01728480]Phase 10 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to Financial Sponsor requested termination)
[NCT01483300]Phase 280 participants (Anticipated)Interventional2011-11-30Recruiting
A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer [NCT01487226]Phase 269 participants (Anticipated)Interventional2008-01-31Recruiting
Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors [NCT00066482]19 participants (Actual)Interventional2004-07-31Completed
Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer [NCT00248482]Phase 26 participants (Actual)Interventional2002-02-28Completed
A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors [NCT00415324]Phase 136 participants (Actual)Interventional2006-12-31Completed
Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck [NCT00261703]Phase 2/Phase 3439 participants (Actual)Interventional2002-12-31Completed
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer [NCT00291850]Phase 250 participants (Actual)Interventional2005-06-30Terminated(stopped due to no patient recruitment)
[NCT00083252]Phase 20 participants InterventionalCompleted
A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx [NCT05966194]Phase 2216 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples. [NCT01703910]Phase 229 participants (Actual)Interventional2012-11-30Completed
CRP on Radiobiological and Clinical Studies on Viral-induced Cancer's Response to Radiotherapy With Comprehensive Morbidity Assessment [NCT00122772]Phase 3601 participants (Actual)Interventional2005-11-30Completed
Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resist [NCT00091377]Phase 1/Phase 265 participants (Actual)Interventional2004-08-31Completed
A Randomised Trial of Radical Chemo/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder [NCT00330499]Phase 367 participants (Actual)Interventional2002-10-31Completed
"Phase II Non-Randomized Three Arm Trial of Induction Chemotherapy With Nab-Paclitaxel and Cisplatin (AP: Arms 1 and 3) or Single Agent Nab-paclitaxel (A: Arm 2) as Induction Therapy Followed by Definitive Concurrent Chemoradiation for Locally Advanced Sq [NCT02573493]Phase 296 participants (Actual)Interventional2016-04-13Active, not recruiting
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer [NCT05819892]Phase 121 participants (Anticipated)Interventional2023-07-17Recruiting
A Phase I Study of Concurrent CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC) [NCT00346801]Phase 120 participants (Actual)Interventional2003-09-30Completed
A Phase 1 Study of Oral MRX-1024 in Combination With Standard Fractionation Radiation Therapy and High-Dose Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck Following Surgical Resection [NCT00427102]Phase 10 participants Interventional2007-01-31Terminated(stopped due to No subjects enrolled and PI went to another facility)
A Phase I Trial of Sequential Ipilimumab After Chemoradiation for the Primary Treatment of Patients With Locally Advanced Cervical Cancer Stages IB2/IIA With Positive Para-Aortic Lymph Nodes Only and Stage IIB/IIIB/IVA With Positive Lymph Nodes [NCT01711515]Phase 134 participants (Actual)Interventional2012-10-01Completed
Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial [NCT00434668]Phase 299 participants (Anticipated)Interventional2005-12-31Completed
A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Doses of Cisplatin for Children With Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease [NCT00436657]Phase 110 participants (Actual)Interventional2007-02-28Completed
Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC) [NCT00349492]Phase 3372 participants (Anticipated)Interventional2006-06-30Completed
Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients [NCT00478699]Phase 3500 participants (Actual)Interventional2007-06-30Completed
A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer [NCT00405405]Phase 113 participants (Actual)Interventional2006-12-31Completed
A Randomized Phase II Trial Evaluating Chemotherapy Plus Atezolizumab vs Chemotherapy Plus Bevacizumab and Atezolizumab in Advanced Combined Hepatocellular Carcinoma-Cholangiocarcinoma [NCT05211323]Phase 288 participants (Anticipated)Interventional2022-12-07Recruiting
A Phase II Study of Adjuvant Postoperative Radiation With Cisplatin Followed by Carboplatin/Paclitaxel Chemotherapy Following Total Abdominal Hysterectomy/Bilateral Salpino-Oophorectomy (TAH/BSO) for Patients With Stage I, II and IIIa Malignant Mixed Meso [NCT00505492]Phase 24 participants (Actual)Interventional2002-02-28Terminated(stopped due to Slow accrual.)
Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC) [NCT05514912]Phase 20 participants (Actual)Interventional2024-03-01Withdrawn(stopped due to PI has decided to terminate this study due to study supporter pulling support on this study.)
A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer [NCT03952585]Phase 2/Phase 3590 participants (Anticipated)Interventional2019-10-09Suspended(stopped due to End of Initial Phase of Multi-phase protocol)
Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2 [NCT00002882]Phase 3140 participants (Actual)Interventional1995-11-30Completed
Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer [NCT00511992]Phase 220 participants (Actual)Interventional2007-07-31Completed
Phase 2 Study of Inductive Plus Concurrent Chemoradiation Versus Concurrent Plus Adjuvant Chemoradiation for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT [NCT01797900]Phase 2130 participants (Actual)Interventional2013-03-31Completed
A Phase II Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-Host-Exhausting and Timely Dose-Reduced Mel-80-CFZ-TD-Pace Transplant(s) With Interspersed Mel-20-CFZ-TD-Pace With CFZ-RD and CFZ-D Ma [NCT02128230]Phase 220 participants (Actual)Interventional2014-06-10Terminated(stopped due to Low enrollment and Futility as determined by Amgen's Carfilzomib NASCR program.)
Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study [NCT05214222]Phase 2100 participants (Anticipated)Interventional2022-09-02Recruiting
A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies [NCT02983045]Phase 1/Phase 2557 participants (Actual)Interventional2016-12-19Completed
A Prospective Phase II Clinical Trial of Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Locally Advanced Nasopharyngeal Carcinoma [NCT04769076]Phase 240 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters [NCT00603408]Phase 25 participants (Actual)Interventional2007-12-31Terminated(stopped due to Study was discontinued due to lack of accrual.)
Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer [NCT01783951]Phase 1/Phase 263 participants (Actual)Interventional2013-02-01Completed
Sun Yat-sen Memorial Hospital, Sun Yat-sen University [NCT05444673]Phase 430 participants (Anticipated)Interventional2022-06-01Recruiting
Phase I Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck [NCT02474368]Phase 121 participants (Actual)Interventional2015-11-30Active, not recruiting
Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation [NCT00653068]Phase 370 participants (Actual)Interventional2008-12-08Active, not recruiting
A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer [NCT01674842]Phase 155 participants (Actual)Interventional2012-10-31Completed
Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy [NCT00005840]Phase 135 participants (Actual)Interventional2000-07-31Completed
Phase II Trial Of Surgery With Perioperative RPR/INGN 201 (Ad5CMV-p53) Gene Therapy Followed By Chemoradiotherapy For Advanced, Resectable Squamous Cell Carcinoma Of The Oral Cavity, Oropharynx, Larynx, and Pharynx [NCT00017173]Phase 213 participants (Actual)Interventional2003-02-28Terminated(stopped due to Terminated for poor accrual.)
A Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination With Cisplatin in Subjects With Advanced or Refractory Non-small Cell Lung Cancer or Biliary Tract Carcinoma [NCT04733521]Phase 1/Phase 2100 participants (Anticipated)Interventional2021-05-01Not yet recruiting
A Phase III Study Comparing Etoposide and Cisplatin (EP) With Irinotecan and Cisplatin (IP) Following EP Plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for Limited-Stage Small-Cell Lung Cancer : JCOG0202-MF [NCT00144989]Phase 3281 participants (Actual)Interventional2002-09-30Completed
Feasibility Study for Multicenter Randomized Controlled Phase III Clinical Trial of Cisplatin + Irinotecan Therapy and Cisplatin + Irinotecan + Krestin Therapy for Extensive-Stage Disease (ED) Small Cell Lung Cancer [NCT00546130]Phase 245 participants (Anticipated)Interventional2007-11-30Recruiting
A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer [NCT00548821]Phase 30 participants InterventionalNot yet recruiting
Phase I Clinical and Pharmacokinetic Study of CBP501 and Cisplatin Every 3 Weeks in Patients With Advanced Refractory Solid Tumors [NCT00551512]Phase 148 participants (Actual)Interventional2006-11-30Completed
A Multicenter Randomized Phase III Trial of Neo-adjuvant Chemotherapy Followed by Surgery and Chemotherapy or by Surgery and Chemoradiotherapy in Resectable Gastric Cancer (CRITICS Study) [NCT00407186]Phase 3788 participants (Actual)Interventional2007-01-11Active, not recruiting
Phase II Study to Evaluate the Efficacy of Upfront Obinutuzumab in Mantle Cell Lymphoma Patients Treated by DHAP Followed by Autologous Transplantation Plus Obinutuzumab Maintenance Then MRD Driven Maintenance [NCT02896582]Phase 286 participants (Actual)Interventional2016-10-31Active, not recruiting
A Phase â… b/II Study of Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in Patients With Small Cell Lung Cancer [NCT04996771]Phase 1/Phase 288 participants (Anticipated)Interventional2021-11-09Recruiting
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study [NCT04900623]Phase 275 participants (Anticipated)Interventional2021-07-02Recruiting
A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion [NCT04255771]Phase 3200 participants (Anticipated)Interventional2020-03-01Not yet recruiting
A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) [NCT00496275]Phase 117 participants (Actual)Interventional2006-08-31Completed
DREAM3R: DuRvalumab (MEDI4736) With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma - A Phase 3 Randomised Trial [NCT04334759]Phase 3214 participants (Actual)Interventional2021-02-18Active, not recruiting
Multi-center Prospective Randomized Controlled Clinical Trial of Postoperative Adjuvant Chemotherapy, Adjuvant Radiotherapy, or Surgery Alone for High-risk Histological Node Negative Patients With Thoracic Esophageal Squamous Cell Carcinoma [NCT02891083]Phase 3486 participants (Anticipated)Interventional2016-01-31Recruiting
NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor [NCT00483093]Phase 122 participants (Actual)Interventional2007-07-31Completed
A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement [NCT00507962]Phase 151 participants (Actual)Interventional2005-03-31Completed
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer [NCT04692051]Phase 2100 participants (Anticipated)Interventional2019-09-01Recruiting
A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy) [NCT02998385]Phase 3342 participants (Anticipated)Interventional2017-01-20Recruiting
A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. [NCT00336024]Phase 391 participants (Actual)Interventional2007-08-06Active, not recruiting
A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding [NCT01525771]Phase 1/Phase 237 participants (Actual)Interventional2011-02-28Completed
A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) [NCT01528618]Phase 3362 participants (Actual)Interventional2012-02-21Completed
Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study [NCT01536223]Phase 3400 participants (Anticipated)Interventional2012-04-30Recruiting
Phase II Trial of Neoadjuvant Chemotherapy for HPV-Associated Squamous Cell Carcinoma of the Oropharynx Followed by Reduced Dose Radiotherapy/Chemoradiotherapy for Responders or Standard Dose Chemoradiotherapy for Non-Responders [NCT01525927]Phase 22 participants (Actual)Interventional2010-08-31Terminated(stopped due to Principal Investigator left institution. IRB approval lapsed.)
Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma [NCT01554397]Phase 2/Phase 370 participants (Actual)Interventional2011-10-13Active, not recruiting
Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer [NCT00101842]Phase 1/Phase 261 participants Interventional2004-12-31Completed
A Prospectively Randomized Controlled Clinical Trial Comparing TheraSphere With Cisplatin-Based TACE (Trans Arterial Chemo Embolization) in the Management of Advanced Stage, Unresectable Hepatocellular Carcinoma (HCC) [NCT00109954]Phase 3120 participants (Anticipated)Interventional2005-02-28Completed
Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors [NCT00116896]Phase 125 participants Interventional2003-06-30Completed
An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer. [NCT00043927]Phase 3760 participants Interventional2001-04-30Completed
Management Of Anemia Under RadioChemotherapy (MARCH): An Open, Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy (Rad [NCT00046969]Phase 4450 participants (Anticipated)Interventional2002-07-31Completed
Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation [NCT00054067]Phase 30 participants Interventional2003-02-28Terminated
Phase I/II Trial of the Epothilone B Analogue BMS 247550 (NSC 710428)/Cisplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck [NCT00057850]Phase 1/Phase 227 participants (Actual)Interventional2002-01-31Completed
Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma: a Phase II Randomized Controlled Trial [NCT02969473]Phase 2120 participants (Anticipated)Interventional2010-10-31Active, not recruiting
A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer [NCT00072787]Phase 1/Phase 241 participants Interventional2003-10-31Completed
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma [NCT00077545]Phase 239 participants (Anticipated)Interventional2004-01-31Completed
Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis [NCT03079427]Phase 2101 participants (Actual)Interventional2017-05-15Completed
A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers [NCT00011960]Phase 20 participants Interventional2001-05-31Completed
Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck [NCT00011999]Phase 270 participants (Actual)Interventional2001-03-31Completed
Phase II Multidose, Single Arm, Multicenter Clinical Trial of Cisplatin and Gemcitabine in Combination With Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in Patients Who Have Untreated p185HER2 Overexpressing Advanced Local Stage (St [NCT00016367]Phase 222 participants (Actual)Interventional1999-05-13Completed
A Phase I Study Of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) In Combination With Cisplatin And Paclitaxel In Patients With Advanced And Metastatic Cancer [NCT00016874]Phase 10 participants Interventional2000-12-31Completed
An Open Label, Sequential Multi-Center Multi Dose Study Of G17T Immunogen In Combination With Cisplatin (CDDP) And 5-Fluorouracil (5-FU) In Subjects With Metastatic Or Locally Recurrent Gastric Or Gastroesophageal Cancer Previously Untreated With Chemothe [NCT00020787]Phase 38 participants (Actual)Interventional2001-07-31Completed
Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lun [NCT00021333]Phase 229 participants (Actual)Interventional1999-09-30Completed
A Two-blinded, Multicentre, Phase II/III RCT of Concurrent Chemo-radiotherapy Combined or Not Combined With TNF as the Therapy for Local-advancedNPC [NCT05433597]Phase 2/Phase 3172 participants (Anticipated)Interventional2022-07-01Not yet recruiting
A Phase I Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer. [NCT00846443]Phase 112 participants (Anticipated)Interventional2009-01-31Recruiting
A Phase 1 / Phase 2 Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer [NCT02990468]Phase 1/Phase 229 participants (Actual)Interventional2017-04-19Completed
ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer [NCT02855944]Phase 3349 participants (Actual)Interventional2017-03-01Completed
An Exploratory Phase II Clinical Trial of Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Cancer [NCT05772377]Phase 236 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin [NCT00024323]Phase 10 participants Interventional2001-03-31Completed
A Phase I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function [NCT00398424]Phase 124 participants (Anticipated)Interventional2006-02-28Completed
Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage [NCT01631136]Phase 3932 participants (Actual)Interventional2012-07-31Completed
Promuneâ„¢ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study [NCT00070629]Phase 2116 participants (Actual)Interventional2003-05-31Completed
An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease [NCT00202969]Phase 3180 participants (Anticipated)Interventional2005-07-31Completed
Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer. [NCT00209716]Phase 1/Phase 230 participants (Anticipated)Interventional2003-12-31Completed
A Phase II Study of Cisplatin and Irinotecan Induction Chemotherapy, Followed by ZD 1839 (IRESSA) in Adult Patients With Surgically Unresectable and/or Metastatic Esophageal or Gastric Carcinomas [NCT00215995]Phase 221 participants (Actual)Interventional2003-07-31Completed
Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients [NCT00122746]Phase 3322 participants (Anticipated)Interventional2004-12-31Recruiting
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT00077883]Phase 1/Phase 250 participants (Anticipated)Interventional2004-02-29Completed
Phase I Trial of Cisplatin, Pemetrexed, and Imatinib Mesylate in Unresectable or Metastatic Malignant Mesothelioma [NCT00402766]Phase 119 participants (Actual)Interventional2006-08-31Completed
A Phase II Evaluation Of Triapine (NCI-Supplied Agent: NSC #663249, IND #68338) In Combination With Cisplatin (Commercially Available: NSC # 119875) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma [NCT00081276]Phase 248 participants (Actual)Interventional2005-07-31Completed
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse [NCT00147160]Phase 287 participants (Anticipated)Interventional2003-10-31Completed
A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer [NCT00154804]Phase 240 participants (Actual)Interventional2001-08-31Completed
Weekly Low-dose Paclitaxel (Phyxol) Plus 24-Hour Infusion of Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer [NCT00154882]Phase 243 participants (Anticipated)Interventional2003-09-30Recruiting
UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients [NCT00083538]Phase 240 participants (Actual)Interventional2001-02-28Completed
Phase II Study Comparing Radiochemotherapy With the Folfox 4 Regimen Versus Radiochemotherapy With 5FU-Cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Esophageal Cancer [NCT00160030]Phase 297 participants (Actual)Interventional2004-09-30Completed
Clinical Study of Toripalimab Combined With Anlotinib, Etoposide and Platinum in the Treatment of Extensive-stage Small Cell Lung Cancer [NCT04731909]80 participants (Anticipated)Interventional2018-10-01Recruiting
A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage [NCT00174772]Phase 272 participants (Actual)Interventional2004-03-31Completed
Prospective Phase I/II Study of Adjuvant Radiochemotherapy for Gastric Cancer [NCT00188266]Phase 1/Phase 265 participants (Anticipated)Interventional2002-08-31Completed
Lipiodol-based Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Cisplatin Particle Suspension [NCT03268499]Phase 277 participants (Actual)Interventional2016-09-09Completed
A Randomised Phase III Study in Advanced Oesophageal Cancer to Compare Quality of Life and Palliation of Dysphagia in Patients Treated With Radiotherapy vs ChemoRadiotherapy. [NCT00193882]Phase 3220 participants (Actual)Interventional2003-07-07Completed
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study [NCT00198367]Phase 2120 participants (Actual)Interventional2003-01-31Completed
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07) [NCT01614132]Phase 1/Phase 233 participants (Actual)Interventional2009-01-31Completed
Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy [NCT02432365]Phase 264 participants (Anticipated)Interventional2015-02-28Recruiting
A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer [NCT01016561]12 participants (Actual)Interventional2009-07-31Terminated(stopped due to Poor accrual/enrollments)
A Randomized, Open, Multicenter Phase 1/Phase 2 Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squ [NCT05783921]Phase 1/Phase 260 participants (Anticipated)Interventional2023-05-23Recruiting
Adaptive-Dose to Mediastinum With Immunotherapy (Durvalumab MEDI4736) and Radiation in Locally-Advanced Non-Small Cell Lung Cancer [NCT04372927]Phase 21 participants (Actual)Interventional2021-12-10Terminated(stopped due to Terminated due to slow accrual)
A Phase II Clinical Trial of Neoadjuvant Chemotherapy With M-VAC Plus Avastin in Patients With Locally Advanced Urothelial Cancer [NCT00506155]Phase 260 participants (Actual)Interventional2007-06-30Completed
A Phase II Trial of Combination of Toripalimab and Definitive Chemoradiotherapy in Esophageal Squamous Cell Carcinoma [NCT04005170]Phase 242 participants (Actual)Interventional2019-06-25Completed
A Randomized Phase II Study of Neoadjuvant PD-1 Blockade Alone or Plus TPF Induction Chemotherapy for Resectable Local Advanced Oral Squamous Cell Carcinoma [NCT04649476]Phase 268 participants (Actual)Interventional2021-03-22Active, not recruiting
Durvalumab and Standard Chemotherapy for the Treatment of Lymph Node Positive Bladder Cancer [NCT05137262]Phase 260 participants (Anticipated)Interventional2021-10-13Recruiting
Phase II Trial of Durvalumab (MEDI4736) Maintenance Therapy After Concurrent Chemoradiation Therapy With Durvalumab (MEDI4736) for Limited Disease-small Cell Lung Cancer [NCT03585998]Phase 251 participants (Actual)Interventional2018-06-19Active, not recruiting
Feasibility Trial of Intraperitoneal Chemotherapy in Stage IA, IB, IC, II, III, IV and Recurrent Platinum Sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma and Stage III and IV Uterine Cancer [NCT00582205]Phase 221 participants (Actual)Interventional2006-01-31Terminated(stopped due to Study completed per investigator.)
A Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma [NCT00515411]Phase 2111 participants (Actual)Interventional2006-10-23Completed
A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma [NCT04405154]Phase 232 participants (Anticipated)Interventional2020-06-01Not yet recruiting
A Randomized Phase II Study of Gemcitabine, Cisplatin +/- Veliparib in Patients With Pancreas Adenocarcinoma and a Known BRCA/ PALB2 Mutation (Part I) and a Phase II Single Arm Study of Single-Agent Veliparib in Previously Treated Pancreas Adenocarcinoma [NCT01585805]Phase 2107 participants (Anticipated)Interventional2012-05-15Active, not recruiting
Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial [NCT04559139]Phase 2/Phase 3186 participants (Anticipated)Interventional2021-02-24Recruiting
A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA) [NCT01893801]Phase 1/Phase 225 participants (Actual)Interventional2013-05-31Completed
Phase I Open Label Trial of Alimta® Plus Cisplatin and Paclitaxel Given Intraperitoneally (IP) as First Line Treatment for Women With Stage III Ovarian Cancer [NCT00702299]Phase 115 participants (Actual)Interventional2007-09-30Completed
Definitive Chemo-Radiotherapy With or Without Up-front Neck Dissection for Regionally Advanced Head and Neck Squamous Cell Carcinoma: A Phase III Multi-center Prospective Randomized Controlled Trial With Two Additional Observational Cohorts [NCT02918955]Phase 365 participants (Anticipated)Interventional2016-10-31Recruiting
A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years [NCT02986503]100 participants (Actual)Observational2002-01-31Completed
Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus. [NCT01834963]Phase 266 participants (Anticipated)Interventional2013-03-31Recruiting
Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma [NCT06019130]Phase 257 participants (Anticipated)Interventional2023-01-10Recruiting
Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study [NCT00304070]Phase 378 participants (Actual)Interventional2007-05-03Completed
Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma [NCT01817023]Phase 3590 participants (Anticipated)Interventional2013-04-30Recruiting
A Randomized Phase II Trial of Cisplatin With or Without Wee1 Kinase Inhibitor AZD1775 (MK-1775) for First-line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (RM-SCCHN) [NCT02196168]Phase 26 participants (Actual)Interventional2014-03-31Terminated(stopped due to Inadequate accrual rate)
A Phase I, Single-arm, Open-label, Three Step Dose Escalation Study With Intraperitoneal Pressurized Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal Carcinomatosis [NCT02475772]Phase 115 participants (Actual)Interventional2016-11-30Completed
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer [NCT01487499]Phase 34 participants (Actual)Interventional2011-12-31Terminated(stopped due to Unable to enroll adequate number of participants)
An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Using the Combination Treatment of SHR-1210, Gemcitabine and Cis-platinum by Recurrent and Metastatic NPC [NCT03121716]Phase 123 participants (Actual)Interventional2017-04-26Completed
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial [NCT05255653]Phase 2/Phase 31,615 participants (Anticipated)Interventional2021-11-11Recruiting
Phase III Study Of Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients [NCT00201383]Phase 3161 participants Interventional1999-10-31Completed
A Randomized Phase 2 Trial of Cisplatin/Gemcitabine With or Without M6620 (VX-970) in Metastatic Urothelial Carcinoma [NCT02567409]Phase 287 participants (Actual)Interventional2016-08-19Active, not recruiting
Phase I Dose-Escalation /Phase II Monocentric Open Trial for Evaluation of Safety and Efficacy of Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication or Extrapleural Pneumonectomy for the Treatment of Patients With Malign [NCT01644994]Phase 1/Phase 247 participants (Actual)Interventional2012-11-30Completed
A Phase 2 Study of Neoadjuvant Pembrolizumab-Based Combination Immunotherapy in the Treatment of Early Stage Non-Small Cell Lung Cancer [NCT04061590]Phase 20 participants (Actual)Interventional2020-05-29Withdrawn(stopped due to Low Accrual)
An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma [NCT02265770]Phase 2/Phase 3536 participants (Anticipated)Interventional2015-06-02Recruiting
Randomized Phase II Trial of Two Sequential Schedules of Docetaxel and Cisplatin Followed by Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer. [NCT00424853]Phase 288 participants (Actual)Interventional2005-05-31Completed
Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study [NCT00262769]Phase 3324 participants (Actual)Interventional2005-05-31Completed
A Phase II Study of Weekly Low-Dose Paclitaxel Plus 24-Hour Infusion of Cisplatin as First-Line Chemotherapy for Metastatic Breast Cancer [NCT00270569]Phase 243 participants (Anticipated)Interventional2005-10-31Recruiting
A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer [NCT06139419]Phase 2114 participants (Anticipated)Interventional2023-07-25Recruiting
A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER) [NCT03509012]Phase 1105 participants (Actual)Interventional2018-05-02Active, not recruiting
Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment [NCT00505635]Phase 25 participants (Actual)Interventional2007-03-31Terminated(stopped due to Slow accrual)
[NCT00301301]39 participants ObservationalCompleted
Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Patients With Gastric Cancer and Peritoneal Carcinomatosis: an Open-label, Single-arm, Phase II Clinical Trial [NCT01854255]Phase 235 participants (Actual)Interventional2013-11-30Completed
A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma [NCT00418535]Phase 20 participants Interventional2006-04-30Completed
A Phase II Trial of Durvalumab With Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma [NCT06050252]Phase 227 participants (Anticipated)Interventional2024-02-16Not yet recruiting
A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharynge [NCT06029270]Phase 2156 participants (Anticipated)Interventional2024-02-16Not yet recruiting
A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone) [NCT01501136]Phase 4200 participants (Anticipated)Interventional2011-01-31Recruiting
An Open-label Randomized Phase II Trial of Gemcitabine and Cisplatin With or Without Bevacizumab in EGFR Wild-type Non-squamous Non-small-cell Lung Cancer Patients [NCT01623102]Phase 240 participants (Anticipated)Interventional2013-02-28Recruiting
A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy [NCT01624051]Phase 2144 participants (Anticipated)Interventional2014-07-31Recruiting
Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland [NCT01630226]Phase 2100 participants (Anticipated)Interventional2007-06-30Recruiting
Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer [NCT01631357]Phase 2/Phase 396 participants (Actual)Interventional2014-12-31Completed
Phase 1/2, Open-Label, Safety and Efficacy, Tolerability, Anti-Tumor Effects, Systemic Exposure, and Device Technical Effects of PRV211 in Subjects With T2-T3 Oral Squamous Cell Carcinoma Amenable to Surgery [NCT05893888]Phase 1/Phase 240 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma [NCT01650090]Phase 228 participants (Actual)Interventional2012-08-31Completed
Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma [NCT01655628]Phase 240 participants (Anticipated)Interventional2012-07-31Recruiting
Combination Treatment of S-1 With Paclitaxel Versus Paclitaxel+Cisplatin and 5-Fu+Cisplatin as First-line Treatment in Advanced Esophageal Cancer [NCT01704690]Phase 2/Phase 34 participants (Actual)Interventional2012-08-31Terminated(stopped due to The enrollment of the study is much slower than expected.)
A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Ep [NCT01714908]Phase 2100 participants (Anticipated)Interventional2012-12-14Active, not recruiting
Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer [NCT01733589]Phase 1/Phase 273 participants (Actual)Interventional2012-11-30Completed
Phase I Trial of Dacomitinib Concomitant With Radiotherapy With and Without Cisplatin in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT01737008]Phase 112 participants (Actual)Interventional2013-01-31Completed
Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed Versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell Lung Cancer (NSCLC) [NCT01742767]Phase 20 participants Interventional2012-11-30Recruiting
Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial [NCT02000531]Phase 445 participants (Actual)Interventional2014-01-31Completed
Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC) [NCT05058651]Phase 2/Phase 3189 participants (Anticipated)Interventional2022-06-28Recruiting
A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B [NCT04924101]Phase 2120 participants (Anticipated)Interventional2021-07-15Active, not recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients With EGFRm, Locally Advanced or Metastatic NSCLC Who Have Progr [NCT04765059]Phase 380 participants (Anticipated)Interventional2021-09-12Recruiting
Phase II Randomized Trial of Neo-Adjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC) [NCT03493425]Phase 282 participants (Anticipated)Interventional2019-03-12Recruiting
Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy [NCT01755845]Phase 3300 participants (Anticipated)Interventional2011-01-31Recruiting
Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy [NCT01756170]Phase 3200 participants (Anticipated)Interventional2011-01-31Recruiting
Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer [NCT01801644]60 participants (Actual)Interventional2007-04-30Completed
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials [NCT01810367]Phase 284 participants (Actual)Interventional2011-12-31Completed
A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers [NCT04910386]Phase 2126 participants (Anticipated)Interventional2024-06-01Not yet recruiting
A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma [NCT02256982]3 participants (Actual)Interventional2014-10-31Terminated(stopped due to Slow accrual.)
Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy [NCT01687413]Phase 342 participants (Actual)Interventional2013-01-10Terminated(stopped due to Slow accrual and funding issues)
A Multicenter Phase II Trial of Preoperative Chemotherapy With Gemcitabine/ Cisplatin /S-1 (GCS) for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) [NCT01821248]Phase 225 participants (Anticipated)Interventional2013-07-23Active, not recruiting
IIT2019-20-Zumsteg-HPVOPC: Phase II Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer [NCT04502407]Phase 240 participants (Anticipated)Interventional2021-02-16Active, not recruiting
A Phase 1 / 2 Study of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumours [NCT05116891]Phase 1/Phase 240 participants (Actual)Interventional2021-09-22Completed
Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression [NCT01828736]Phase 261 participants (Actual)Interventional2004-02-09Completed
Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity [NCT01829178]Phase 2/Phase 330 participants (Actual)Interventional2013-08-31Completed
Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation [NCT01843647]Phase 2100 participants (Anticipated)Interventional2013-04-30Recruiting
Neoadjuvant Chemotherapy Plus Tislelizumab Followed by Concurrent Chemoradiotherapy and Maintenance Therapy With Tislelizumab in Patients With Stage IVA Nasopharyngeal Carcinoma: A Single-arm, Phase II Trial [NCT05448885]Phase 250 participants (Anticipated)Interventional2021-09-01Recruiting
RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC [NCT04849377]Phase 20 participants (Actual)Interventional2022-06-14Withdrawn(stopped due to lack of eligible participants due to change in study criterias)
Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx [NCT05551767]Phase 2120 participants (Anticipated)Interventional2022-08-30Recruiting
Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study [NCT03006614]Phase 3320 participants (Anticipated)Interventional2016-04-30Recruiting
Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial [NCT04414566]Phase 3562 participants (Anticipated)Interventional2020-06-01Not yet recruiting
Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. [NCT00357149]Phase 2101 participants (Actual)Interventional2003-01-31Completed
Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients [NCT05746598]178 participants (Anticipated)Observational2020-07-01Recruiting
A Phase I/1b Study of Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer [NCT02300610]Phase 110 participants (Actual)Interventional2015-02-11Completed
Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy [NCT00379665]Phase 225 participants (Actual)Interventional2005-10-31Completed
Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis [NCT00001569]Phase 174 participants Interventional1997-01-31Completed
Phase II Study to Evaluate the Role of Postoperative Radiotherapy for Low Risk of Locoregional Recurrence Patients With Completely Resected Stage IIIA(N2) Non-Small Cell Lung Cancer [NCT02977169]Phase 2300 participants (Anticipated)Interventional2016-11-30Recruiting
Efficacy and Safety of Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-001) [NCT04389177]Phase 250 participants (Anticipated)Interventional2020-07-08Active, not recruiting
Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer [NCT03025477]Phase 284 participants (Anticipated)Interventional2016-10-31Recruiting
HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers [NCT05075980]Phase 2117 participants (Anticipated)Interventional2022-02-16Recruiting
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis [NCT04858009]Phase 240 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Multimodality Risk Adapted Therapy Including Carboplatin/Paclitaxel/Lapatinib as Induction for Squamous Cell Carcinoma of the Head and Neck Amenable to Transoral Surgical Approaches [NCT01612351]Phase 240 participants (Actual)Interventional2012-06-30Active, not recruiting
A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer [NCT01461759]Phase 259 participants (Anticipated)Interventional2011-10-31Recruiting
Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma [NCT01462474]Phase 120 participants (Actual)Interventional2011-10-31Completed
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 Intratumoral Injection Combined With Radiotherapy in Patients With Locally Advanced Cervical Cancer [NCT05570422]Phase 170 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03020329]Phase 237 participants (Anticipated)Interventional2016-11-14Recruiting
A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer [NCT01924819]Phase 2/Phase 3574 participants (Actual)Interventional2009-09-30Active, not recruiting
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903) [NCT04138212]Phase 3456 participants (Anticipated)Interventional2019-10-22Recruiting
Neoadjuvant Therapy of Camrelizumab Combined With Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Single-arm, Phase II Clinical Study [NCT05476380]Phase 239 participants (Anticipated)Interventional2021-02-19Recruiting
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial [NCT02143388]Phase 3180 participants (Actual)Interventional2014-03-31Completed
Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation [NCT01151761]Phase 22 participants (Actual)Interventional2011-01-31Terminated(stopped due to Poor accrual)
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC [NCT00001450]Phase 258 participants Interventional1995-09-30Completed
Concurrent Chemoradiotherapy Based of Cisplatin With or Without Sintilimab as First-line Therapy for Patients With Advanced Oral Cavity Squamous Cell Carcinoma :a Phase 2,Prospective, Open-label,Unicentral,Randomised Controlled Trial [NCT05749042]Phase 270 participants (Anticipated)Interventional2023-01-18Recruiting
Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck [NCT00002932]Phase 260 participants (Anticipated)Interventional1997-05-31Completed
A PHASE 1-2 NEOADJUVANT DOSE FINDING, SAFETY, AND IMMUNOLOGIC EFFICACY TRIAL OF INTENSIVE LOCOREGIONAL CHEMOIMMUNOTHERAPY FOR RECURRENT OVARIAN CANCER AND TUMOR-SPECIFIC INTRANODAL AUTOLOGOUS ALPHA-DC1 VACCINES [NCT02432378]Phase 1/Phase 225 participants (Anticipated)Interventional2015-09-04Suspended
Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours [NCT02582697]Phase 3500 participants (Anticipated)Interventional2014-02-28Recruiting
A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients [NCT00002836]Phase 3184 participants (Actual)Interventional1995-09-26Completed
A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma [NCT00003322]Phase 3384 participants (Anticipated)Interventional1998-03-31Completed
Camrelizumab Plus Cisplatin in Advanced Cutaneous Squamous Cell Carcinoma: a Single-arm, Open, Single-center Phase II Study [NCT05490485]Phase 220 participants (Anticipated)Interventional2022-08-05Recruiting
A Phase II Study of Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Gastric Carcinomatosis or Positive Cytology [NCT02092298]Phase 221 participants (Actual)Interventional2014-05-08Completed
Paclitaxel (Albumin-bound) Combined With Radiotherapy Compared With Cisplatin Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma: a Prospective, Parallel-controlled, Multicenter Phase III Clinical Study [NCT04766359]Phase 3364 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy [NCT04019548]Phase 3110 participants (Anticipated)Interventional2019-12-16Recruiting
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma [NCT00602667]Phase 2293 participants (Actual)Interventional2007-12-17Active, not recruiting
A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study [NCT01194453]Phase 2288 participants (Actual)Interventional2009-11-30Completed
An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer [NCT00085631]Phase 3101 participants (Actual)Interventional2003-03-31Terminated(stopped due to Study was closed because of slow accrual)
A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Carcinoma [NCT03086681]Phase 3120 participants (Anticipated)Interventional2017-03-31Not yet recruiting
University of Arkansas (UARK 2001-12), A Phase III Study of DTPACE Followed by Tandem Transplant With MEL 200 Versus MEL/DTPACE Hybrid and DTPACE Consolidation in Patients With Active Multiple Myeloma [NCT00083915]Phase 397 participants (Actual)Interventional2001-06-30Completed
An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 ( Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metast [NCT05221658]Phase 260 participants (Anticipated)Interventional2022-08-25Recruiting
Electrochemotherapy of Gynecological Cancers [NCT04760327]Phase 230 participants (Anticipated)Interventional2020-07-01Recruiting
A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [NCT02392637]Phase 262 participants (Actual)Interventional2015-04-02Completed
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma [NCT03215719]Phase 2144 participants (Anticipated)Interventional2017-07-10Recruiting
A Single-arm, Single-center, Open, Prospective Phase II Clinical Study of Camrelizumab Combined With Radiotherapy and Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer [NCT04884906]Phase 240 participants (Anticipated)Interventional2020-11-01Recruiting
Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial [NCT04772287]Phase 3341 participants (Anticipated)Interventional2021-03-31Not yet recruiting
A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin, Interferon Alfa-2b, and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma [NCT00068575]Phase 229 participants (Actual)Interventional2002-05-31Completed
UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy [NCT00083551]Phase 3668 participants (Actual)Interventional1998-08-31Completed
Efficacy and Safety of Pembrolizumab Plus Neoadjuvant Chemotherapy With Cisplatin and 5-Fluorouracill Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of Esophagogastric Junction [NCT04813523]Phase 230 participants (Anticipated)Interventional2021-04-01Recruiting
Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer [NCT01590017]Phase 241 participants (Actual)Interventional2014-04-01Completed
Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma [NCT03377400]Phase 240 participants (Anticipated)Interventional2017-12-14Active, not recruiting
A Randomized, Controlled, Double-blind Study to Evaluate Efficacy and Survival of Combining Nimotuzumab Plus Concurrent Chemo-radiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma [NCT02409186]Phase 3200 participants (Anticipated)Interventional2015-03-31Recruiting
Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03366415]Phase 3420 participants (Anticipated)Interventional2018-01-01Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma [NCT04426955]Phase 3396 participants (Actual)Interventional2020-06-30Active, not recruiting
A Single Arm, Multicenter Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma [NCT05490719]Phase 250 participants (Anticipated)Interventional2022-08-31Not yet recruiting
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Cisplatin Micelle Injection (HA132) in Patients With Advanced Malignant Solid Tumors [NCT05478785]Phase 1/Phase 2126 participants (Anticipated)Interventional2022-08-31Not yet recruiting
Efficacy and Safety of First-line Etoposide/Platinum-based Chemotherapy Followed by Toripalimab Combined With Anlotinib for Maintenance in Extensive Small Cell Lung Cancer: A Single-arm, Multicentral Phase II Study [NCT04363255]Phase 220 participants (Anticipated)Interventional2020-05-01Not yet recruiting
A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide [NCT03275857]Early Phase 137 participants (Anticipated)Interventional2018-09-21Recruiting
A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma [NCT05527470]Phase 3440 participants (Anticipated)Interventional2022-11-11Recruiting
Chemo-embolization for Head and Neck Cancer [NCT04595981]Phase 248 participants (Anticipated)Interventional2021-03-10Active, not recruiting
Randomized Phase III Clinical Trial of Weekly Versus Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer [NCT01561586]Phase 3374 participants (Anticipated)Interventional2012-03-31Recruiting
[NCT01593306]Phase 380 participants (Anticipated)Interventional2011-07-31Recruiting
Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer [NCT01594099]Phase 245 participants (Anticipated)Interventional2012-04-30Active, not recruiting
Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy [NCT01362127]Phase 2181 participants (Actual)Interventional2006-10-31Completed
A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China [NCT01596868]Phase 260 participants (Anticipated)Interventional2012-05-31Completed
A Phase I Dose Escalation Trial of Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of the Head and Neck [NCT02158234]Phase 120 participants (Actual)Interventional2014-07-16Completed
Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer [NCT01611727]Phase 220 participants (Actual)Interventional2007-07-31Completed
Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial [NCT03690921]Phase 28 participants (Actual)Interventional2018-11-08Completed
Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma [NCT01614938]Phase 246 participants (Actual)Interventional2010-08-31Active, not recruiting
A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder [NCT01616875]Phase 228 participants (Actual)Interventional2012-05-31Active, not recruiting
Tislelizumab Combined With Chemotherapy in the Treatment of Bone Metastases of Unknown Primary: A Prospective, Open-label, Single-arm Clinical Study [NCT05241132]Phase 227 participants (Anticipated)Interventional2021-11-12Recruiting
A Phase III Clinical Trial of Docetaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma [NCT02465736]Phase 3610 participants (Anticipated)Interventional2015-07-31Recruiting
A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent [NCT02104986]Phase 2117 participants (Actual)Interventional2014-05-12Completed
Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma [NCT00347256]60 participants (Anticipated)InterventionalWithdrawn
Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy [NCT01275664]4 participants (Actual)Interventional2011-06-30Terminated(stopped due to Study terminated due to no patient population available)
Multicenter Comparative of Toxicity and Effectiveness of Lobaplation or Cisplatin Based Adjuvant Chemotherapy in Esophageal Carcinoma [NCT03413436]Phase 4733 participants (Actual)Interventional2018-01-31Completed
Randomized Phase 2 Trial of Tirapazamine and the Role of Tumor Hypoxia in Advanced Squamous Head and Neck Cancer [NCT00002774]Phase 263 participants (Actual)Interventional1996-06-30Completed
Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): a Phase I/II Trial of Radiation Dose Escalation and Fixed Dose Chemotherapy. [NCT00379717]Phase 1/Phase 230 participants (Anticipated)Interventional2006-11-30Recruiting
A Two-Stage Phase II Safety and Efficacy Study of IntraDose (Cisplatin/Epinephrine) Injectable Gel (MPI 5010) Administered to Patients With Unresectable Primary Hepatocellular Carcinoma [NCT00003044]Phase 255 participants (Anticipated)Interventional1996-09-30Active, not recruiting
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATIN/EPINEPHRINE INJECTABLE GEL (PRODUCT MPI 5010) WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA O [NCT00002659]Phase 3120 participants (Anticipated)Interventional1995-05-31Active, not recruiting
Phase III Prospective Randomized Study of Craniospinal RT Followed by One of Two Adjuvant Chemotherapy Regimens (CCNU, CDDP, VCR OR CPM, CDDP, VCR) for Newly-Diagnosed Average Risk MedulloblastomaMEDULLOBLASTOMA [NCT00002875]Phase 3421 participants (Actual)Interventional1996-12-31Completed
Protocol for Patients With Newly-Diagnosed Non-Metastatic Osteosarcoma - A POG/CCG Pilot Intergroup Study [NCT00003937]Phase 3253 participants (Actual)Interventional1999-09-30Completed
A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 (Rebeccamycin Analogue) and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days [NCT00004189]Phase 140 participants (Actual)Interventional1999-10-31Completed
A Phase I/II Study Of Whole Pelvic Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis [NCT00003379]Phase 1/Phase 240 participants (Anticipated)Interventional1999-11-30Completed
A Phase I - II Open Label Study of the Maximum Tolerated Dose, Safety and Efficacy of Docetaxel and Cisplatin Plus STI571 in Advanced Non-Small Cell Lung Cancer [NCT02127372]Phase 1/Phase 243 participants (Actual)Interventional2004-11-30Terminated(stopped due to The study was closed due to poor accrual)
Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma [NCT02082522]Phase 328 participants (Actual)Interventional2014-11-12Terminated(stopped due to Accrual rate remaining too low)
Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer [NCT00001499]Phase 250 participants Interventional1996-03-31Completed
A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER: CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL [NCT00002711]Phase 124 participants (Anticipated)Interventional1995-10-31Completed
A Phase III Randomized Trial of Cisplatin (NSC #119875) With Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma [NCT00002717]Phase 3324 participants (Anticipated)Interventional1996-03-31Completed
Induction Chemotherapy Followed By Chemoradiation For Organ Preservation In Patients With Advanced Resectable Cancer Of The Hypopharynx And Base Of Tongue, Phase II [NCT00002735]Phase 268 participants (Actual)Interventional1996-04-30Terminated(stopped due to Terminated due to poor accrual.)
A Phase II Trial of Induction and Maintenance Pembrolizumab and Olaparib in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) [NCT05366166]Phase 245 participants (Anticipated)Interventional2022-09-02Recruiting
A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2) [NCT05061550]Phase 2350 participants (Anticipated)Interventional2022-04-14Recruiting
Phase II Trial of Preoperative Combined Modality Therapy for Localized Esophageal Carcinoma: Cisplatin-Paclitaxel Followed by Radiation Therapy With Concurrent Cisplatin and Paclitaxel [NCT00003087]Phase 225 participants (Anticipated)Interventional1997-08-31Completed
A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors [NCT00003141]Phase 194 participants (Actual)Interventional1998-03-31Completed
A Phase 1-2 Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer [NCT01938573]Phase 1/Phase 221 participants (Actual)Interventional2013-10-31Completed
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial [NCT00085735]Phase 3549 participants (Actual)Interventional2004-04-30Active, not recruiting
A Phase 1 Study of d Limonene With Concurrent Radiation and Platinum Based Chemotherapy for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) [NCT04392622]Phase 130 participants (Anticipated)Interventional2021-02-15Recruiting
A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas [NCT01726582]Phase 2229 participants (Actual)Interventional2011-11-30Completed
A Randomized Phase II Trial of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Paclitaxel and Carboplatin in HIV-positive Women With Locally Advanced Cervical Cancer (LACC) [NCT03834571]Phase 20 participants (Actual)Interventional2022-05-31Withdrawn(stopped due to Not approved by CTEP)
Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas [NCT04268121]Phase 278 participants (Anticipated)Interventional2021-01-05Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer [NCT04158440]Phase 3501 participants (Actual)Interventional2020-04-07Active, not recruiting
Phase II Randomized Trial of Transoral Surgical Resection Followed by Low-Dose or Standard-Dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer [NCT01898494]Phase 2519 participants (Actual)Interventional2014-01-22Active, not recruiting
Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma [NCT00316888]Phase 263 participants (Actual)Interventional2007-02-28Completed
Phase II Study of C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck [NCT00096174]Phase 269 participants (Actual)Interventional2005-04-08Completed
Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus [NCT00033657]Phase 297 participants (Actual)Interventional2002-08-15Completed
QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients [NCT04359199]42 participants (Anticipated)Observational2020-09-01Recruiting
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835]Phase 3116 participants (Actual)Interventional1995-10-30Completed
A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma [NCT00003573]Phase 253 participants (Actual)Interventional1998-11-30Completed
A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer [NCT00004083]Phase 20 participants Interventional1999-02-28Completed
A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer [NCT04537286]Phase 290 participants (Anticipated)Interventional2020-08-25Recruiting
Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial [NCT01809379]Phase 269 participants (Actual)Interventional2013-02-28Completed
Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin [NCT00966914]Phase 3540 participants (Actual)Interventional2010-04-30Completed
Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer:a Phase II , Single-arm Clinical Study [NCT05825443]Phase 257 participants (Anticipated)Interventional2023-04-10Recruiting
Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases [NCT03965234]Phase 1/Phase 299 participants (Anticipated)Interventional2020-07-16Recruiting
Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer [NCT05406674]Phase 240 participants (Anticipated)Interventional2022-06-15Recruiting
A Single-arm Exploratory Clinical Study of Envafolimab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer [NCT05799469]Phase 236 participants (Anticipated)Interventional2023-05-01Not yet recruiting
A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) [NCT02659059]Phase 2324 participants (Actual)Interventional2016-02-15Completed
Phase III Randomized Trial of Immediate Adjuvant Chemotherapy or Delayed Salvage Chemotherapy in Nasopharyngeal Carcinoma Patients With Post-radiation Detectable Plasma EBV DNA [NCT02363400]Phase 3147 participants (Anticipated)Interventional2014-11-30Enrolling by invitation
A Phase III Randomised Trial Investigating the Benefits of the Addition of Modulated Electro-hyperthermia to Chemo-radiation for Cervical Cancer in HIV Positive and Negative Women in South Africa [NCT03332069]Phase 3236 participants (Anticipated)Interventional2014-01-09Recruiting
Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial [NCT03071289]Phase 3540 participants (Anticipated)Interventional2017-06-01Recruiting
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial [NCT02461043]Phase 3386 participants (Anticipated)Interventional2015-04-30Recruiting
Camrelizumab Combined With Chemotherapy for Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma:A Phase II Clinical Study to Explore the Relationship Between Biomarkers and Efficacy [NCT04937673]Phase 240 participants (Anticipated)Interventional2021-07-01Not yet recruiting
Phase II Randomized Trial Comparing Paclitaxel Combined With DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03047265]Phase 2164 participants (Anticipated)Interventional2017-02-04Active, not recruiting
Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma [NCT03042429]Phase 3360 participants (Actual)Interventional2007-01-01Completed
Fluzoparib Combined With Camrelizumab for Maintenance Treatment of Locally Advanced Non-small Cell Lung Cancer After Concurrent Chemotherapy and Radiotherapy. A Single-arm, Single-center, Phase II Clinical Study [NCT04828395]Phase 265 participants (Anticipated)Interventional2021-03-01Recruiting
An Open Label, Single Arm Phase II Study of Camrelizumab in Combination With Cisplatin and Nab-paclitaxel as a Novel Neoadjuvant Pre-Surgical Therapy for Resectable HNSCC [NCT04826679]Phase 253 participants (Anticipated)Interventional2021-04-01Recruiting
Phase II Trial To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix [NCT04789941]Phase 250 participants (Anticipated)Interventional2021-04-01Not yet recruiting
A Multicenter, Randomized, Non-inferior Phase III Study of Radiotherapy Alone Versus Concurrent Chemo-radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Complete Remission of EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy [NCT05674305]Phase 3366 participants (Anticipated)Interventional2022-01-01Recruiting
A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma [NCT03117257]Phase 2144 participants (Anticipated)Interventional2016-08-19Recruiting
Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEXâ„¢ Plus CT in Comparison to Cetuximab Plus CT in Patients With Stage III/IV Recurrent and/or Metastatic SCCHN [NCT02052960]Phase 2240 participants (Actual)Interventional2014-02-28Completed
Open-label, Uncontrolled, Multicenter Phase I/Ib Trial to Investigate Safety and Efficacy of BIBW 2992 and Standard Gemcitabine/Cisplatin in Chemo-naïve Patients With Advanced Biliary Tract Adenocarcinoma [NCT01679405]Phase 19 participants (Actual)Interventional2012-08-31Terminated(stopped due to No sufficient clinical or molecular signals for efficacy were observed.)
The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma) [NCT03374280]Phase 2178 participants (Anticipated)Interventional2016-12-01Recruiting
Effect of Refnot on Immunity in Cancer Patients [NCT05898451]Phase 255 participants (Actual)Interventional2009-06-04Completed
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer [NCT03100955]Phase 3120 participants (Anticipated)Interventional2017-03-01Recruiting
A Phase Ib/II Trial of GDC-0941 (a PI3K Inhibitor) in Combination With Cisplatin in Patients With Androgen Receptor Negative Triple Negative Metastatic Breast Cancer [NCT01918306]Phase 1/Phase 211 participants (Actual)Interventional2013-09-30Terminated(stopped due to company stopped production of study drug due to excessive toxicities, lack of efficacy)
Phase Ib/II Clinical Study of IAH0968 in Combination With Gemcitabine and Cisplatin for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors and Cholangiocarcinoma [NCT05991518]Phase 1/Phase 2136 participants (Anticipated)Interventional2023-04-25Recruiting
A Pilot Multi-arm Study of sEphB4-HSA in Combination With Different Chemotherapy Regimens in Patients With Specific Advanced or Metastatic Solid Tumors [NCT02495896]Phase 161 participants (Actual)Interventional2015-09-03Terminated(stopped due to Lack of funding)
Prospective, Phase II Study to Evaluate the Efficacy of Addition of Progesterone to Standard Chemotherapy According to Etoposide-Doxorubicin-Cisplatin Scheme Plus Mitotane (EDP-M) in Patients With Advanced Adrenocortical Carcinoma (ACC) [NCT05913427]Phase 280 participants (Anticipated)Interventional2022-06-08Recruiting
Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes [NCT05167487]150 participants (Anticipated)Observational2021-12-13Recruiting
Nivolumab Plus Ipilimumab Plus Two Cycles of Platinum-based Chemotherapy as First Line Treatment for Stage IV/Recurrent Non-small Cell Lung Cancer (NSCLC) Patients With Synchronous Brain Metastases [NCT05012254]Phase 271 participants (Anticipated)Interventional2021-11-18Recruiting
Induction Durvalumab Followed by Chemoradiation and Consolidation Durvalumab (MEDI4736) for Stage III Non-small Cell Lung Cancer [NCT04364048]Phase 210 participants (Actual)Interventional2020-06-18Active, not recruiting
Twice-daily Radiotherapy by Simultaneous Integrated Boosting Technique Versus Twice-daily Standard Radiotherapy for Patients With Limited-stage Small Cell Lung Cancer: a Multicenter, Randomized, Controlled, Phase III Study [NCT03214003]235 participants (Actual)Interventional2017-06-30Completed
A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker [NCT01982448]Phase 2147 participants (Actual)Interventional2014-04-30Completed
Phase II Trial of Post-Operative Adjuvant Paclitaxel + Cisplatin in Patients With Adenocarcinoma of the Esophagus, Gastro-Esophageal Junction or Cardia [NCT00003237]Phase 255 participants (Anticipated)Interventional1998-06-22Completed
Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer [NCT05492123]Phase 2112 participants (Anticipated)Interventional2022-08-30Recruiting
BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001 [NCT00522795]Phase 240 participants (Actual)Interventional2007-08-31Completed
A Phase I, Open-Label Study Evaluating the Pharmacokinetics of Components of S-1 in Patients With Varying Degrees of Renal Function [NCT00398307]Phase 124 participants (Anticipated)Interventional2006-02-28Completed
Phase II Multicenter Randomized Trial Evaluating the Association of PIPAC and Systemic Chemotherapy Versus Systemic Chemotherapy Alone as 1st-line Treatment of Malignant Peritoneal Mesothelioma [NCT03875144]Phase 266 participants (Anticipated)Interventional2020-08-14Recruiting
Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX) [NCT03255252]Phase 229 participants (Actual)Interventional2017-07-15Active, not recruiting
Carboplatin-Paclitaxel Induction Chemotherapy and ABT-888 (Veliparib) - a Phase 1/Randomized Phase 2 Study in Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT01711541]Phase 1/Phase 224 participants (Actual)Interventional2012-10-22Completed
A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy [NCT00134030]Phase 31,334 participants (Actual)Interventional2005-11-14Completed
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC) [NCT01822496]Phase 259 participants (Actual)Interventional2013-11-04Terminated
Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study [NCT01670890]Phase 2120 participants (Anticipated)Interventional2012-08-31Recruiting
A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations [NCT01670500]Phase 2118 participants (Actual)Interventional2012-10-31Active, not recruiting
A Phase II Study of Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children With Central Nervous System Atypical Teratoid/Rhabdoid Tumor (AT/RT) Tumor [NCT00084838]Phase 225 participants (Actual)Interventional2003-02-28Completed
Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma: A Exploratory Clinical Trial [NCT04413734]Phase 2120 participants (Anticipated)Interventional2020-04-22Recruiting
Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas [NCT00083122]Phase 245 participants (Actual)Interventional2004-04-30Completed
A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC) [NCT03790111]Phase 253 participants (Actual)Interventional2019-03-13Terminated(stopped due to Did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis)
Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer [NCT03410030]Phase 1/Phase 227 participants (Actual)Interventional2017-12-15Completed
A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Paricalcitol as Pre-operative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas [NCT03138720]Phase 224 participants (Actual)Interventional2017-05-23Active, not recruiting
A Phase 3 Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy Incorporating a Randomized Assessment of Sodium Thiosulfate as Otoprotection for Children With Localized Disease, and Respons [NCT04478292]Phase 3330 participants (Anticipated)Interventional2021-03-01Recruiting
A Phase I Study of Methoxyamine Combined With Chemo-Radiation for Locally Advanced Non-Squamous Non-Small Cell Lung Cancer [NCT02535325]Phase 117 participants (Actual)Interventional2015-09-30Completed
A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy Followed By Standard Chemoradiation In HPV-Negative or High-risk HPV-Positive Locally Advanced Stage III/IVa/IVb HNSCC [NCT01732640]Phase 1/Phase 29 participants (Actual)Interventional2012-12-31Terminated(stopped due to Slow accrual and high levels of toxicity lead to early termination.)
Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC. [NCT00148798]Phase 31,861 participants (Actual)Interventional2004-10-31Completed
A Prospective, Single Arm, Single Center, Phase II Clinical Trial of Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell [NCT04520035]Phase 260 participants (Anticipated)Interventional2020-08-01Recruiting
LS1781: Phase 2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed / Refractory Lymphoma and Patients With Clonal Cytopenia of Undetermined Significance [NCT03418038]Phase 255 participants (Anticipated)Interventional2018-03-23Recruiting
A Phase I Trial for the Use of Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment of BCG-Refractory Non-muscle Invasive Urothelial Carcinoma of the Bladder Cancer [NCT02202772]Phase 1/Phase 251 participants (Anticipated)Interventional2014-12-01Recruiting
Phase I/II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin in Patients With Advanced Solid Tumors and in Chemotherapy-naïve Patients With Malignant Pleural Mesothelioma [NCT00700336]Phase 1/Phase 269 participants (Actual)Interventional2008-05-31Completed
A Phase 3, Prospective,Multicenter, Randomized Open-Label Trial to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Chemotherapy Followed By Surgery Versus Up-Front Surgery as Treatment for Resectable Head And Ne [NCT05582265]Phase 3588 participants (Anticipated)Interventional2022-10-28Recruiting
Comparative Study of Different Doses of Magnesium as a Protective Agent in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer [NCT05586009]Phase 275 participants (Anticipated)Interventional2022-10-31Enrolling by invitation
A Phase Ib/II Trial of Neoadjuvant Tiragolumab, Atezolizumab, Paclitaxel, Cisplatin and Radiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma [NCT05743504]Phase 1/Phase 232 participants (Anticipated)Interventional2023-03-01Not yet recruiting
A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865) Versus the Non-platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, in Stage IVB, Recurrent or Persistent [NCT00803062]Phase 3452 participants (Actual)Interventional2009-04-30Completed
A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary [NCT01042522]Phase 263 participants (Actual)Interventional2010-02-08Active, not recruiting
Trial of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Primary Peritoneal Cancers and Secondary Peritoneal Cancers From Stomach, Colorectal, Appendiceal, and/or Gynecological Origins [NCT03604653]10 participants (Actual)Observational2018-05-15Completed
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer [NCT05620654]Phase 130 participants (Anticipated)Interventional2022-12-01Recruiting
A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma [NCT01670409]Phase 285 participants (Actual)Interventional2012-08-31Completed
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma Based On The AJCC 8th Edition Staging Manual [NCT04638465]150 participants (Anticipated)Observational2018-08-06Active, not recruiting
A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma FRONTiER Trial [NCT03914443]Phase 136 participants (Anticipated)Interventional2019-05-07Active, not recruiting
Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma [NCT00085098]Phase 324 participants (Actual)Interventional2007-01-31Completed
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451) [NCT01101451]Phase 3341 participants (Actual)Interventional2010-04-12Active, not recruiting
A Randomized Phase II Study of SUBATM-itraconazole With Cisplatin/Gemcitabine in Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer. [NCT01752023]Phase 23 participants (Actual)Interventional2013-03-31Terminated(stopped due to Low Accrual)
A Phase 1B Study to Evaluate the Safety and Induction of Immune Response of CRS-207 in Combination With Pemetrexed and Cisplatin as Front-line Therapy in Adults With Malignant Pleural Mesothelioma [NCT01675765]Phase 160 participants (Actual)Interventional2014-09-03Completed
A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of Intratumoral INT230-6 in Early Stage Breast Cancer: The INVINCIBLE Trial [NCT04781725]Phase 290 participants (Anticipated)Interventional2021-03-25Recruiting
A Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study of SHR-1701 in Combination With Bevacizumab and Chemotherapy in Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer With EGFR Mutation After Failure of TKIs [NCT05132413]Phase 3561 participants (Anticipated)Interventional2021-12-30Not yet recruiting
Neoadjuvant Chemotherapy and Tilelizumab in Stage III(cTNM-IIIA.IIIB)Non-small-cell Lung Cancer ,a Single-arm, Phase Ⅱ Clinical Trial [NCT04865705]Phase 233 participants (Anticipated)Interventional2020-11-10Active, not recruiting
Durvalumab With Chemotherapy Followed by Sequential Radiotherapy for Limited Stage Small Cell Lung Cancer: A Single-arm Phase II Trial. [NCT05034133]Phase 220 participants (Anticipated)Interventional2021-09-01Recruiting
A Multicenter Exploratory Study of Paclitaxel+Cisplatin+TQB2450 Injection Combined With or Without Anlotinib in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma [NCT05013697]Phase 248 participants (Anticipated)Interventional2021-09-30Not yet recruiting
A Phase 1/2 Study of the Bromodomain Inhibitor ZEN003694 in Combination With Etoposide/Platinum in Patients With NUT Carcinoma [NCT05019716]Phase 1/Phase 255 participants (Anticipated)Interventional2022-07-13Recruiting
Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol [NCT00003569]2 participants (Actual)Observational1998-03-31Completed
An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors [NCT00003203]Phase 2168 participants (Actual)Interventional1998-03-31Completed
Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck [NCT00005087]Phase 2105 participants (Actual)Interventional2000-03-31Completed
A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412) [NCT03040999]Phase 3804 participants (Actual)Interventional2017-04-05Active, not recruiting
LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Pl [NCT01907100]Phase 2/Phase 3545 participants (Actual)Interventional2013-09-19Terminated
A Phase 1 Trial of the ATR Inhibitor BAY 1895344 in Combination With Cisplatin and With Cisplatin Plus Gemcitabine in Advanced Solid Tumors With an Emphasis on Urothelial Carcinoma [NCT04491942]Phase 174 participants (Anticipated)Interventional2021-08-25Active, not recruiting
A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer [NCT02662634]Phase 20 participants (Actual)Interventional2016-03-31Withdrawn
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer [NCT05235516]Phase 3636 participants (Anticipated)Interventional2022-06-21Recruiting
Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, and Hypopharynx: Incorporation of Intensity Modulated Radiotherapy and Submandibular Gland Transfer to Minimize Treatment Morbid [NCT00566540]Phase 211 participants (Actual)Interventional2007-12-11Terminated(stopped due to Recruitment problems with study)
A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas [NCT01277744]Phase 222 participants (Actual)Interventional2011-05-09Completed
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations. [NCT03381066]Phase 3225 participants (Anticipated)Interventional2018-04-10Recruiting
Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma [NCT03469531]Phase 2100 participants (Anticipated)Interventional2018-03-20Recruiting
A Phase I Clinical Trial of AZD1775 in Combination With Neoadjuvant Weekly Docetaxel and Cisplatin Prior to Surgery in Squamous Cell Carcinoma of the Head and Neck (HNSCC) [NCT02508246]Phase 112 participants (Actual)Interventional2015-07-22Completed
Radiotherapy Combined With Immune Checkpoint Inhibitors (ICIs) as Treatment for Locally Advanced Non-small-cell Lung Cancer After Failing Induction Immuno-chemotherapy: a Prospective, Real-world Cohort Study. [NCT06031597]Phase 3105 participants (Anticipated)Interventional2023-09-15Not yet recruiting
LCCC 1612: P53 Mutational Status and Circulating Free HPV DNA for the Management of HPV-associated Oropharyngeal Squamous Cell Cancers [NCT03077243]Phase 2215 participants (Actual)Interventional2016-12-31Active, not recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Chemotherapy in the Treatment of EGFR WT and ALK WT Recurrent and Metastatic Non-small Cell Lung Cancer [NCT05020457]Phase 260 participants (Anticipated)Interventional2021-12-07Recruiting
PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer [NCT03774732]Phase 3327 participants (Anticipated)Interventional2019-03-21Recruiting
A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma [NCT02936388]Phase 2108 participants (Anticipated)Interventional2016-01-31Recruiting
"Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma: A Feasibility Phase II Randomized Clinical Trial (URANUS)" [NCT02969083]Phase 2200 participants (Anticipated)Interventional2018-05-28Recruiting
Phase â…¡Trial of S1 Capsule Plus Cisplatin Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage â…¡-â…¢A Non-small Cell Lung Cancer (NSCLC) After Complete Resection [NCT02223611]Phase 2100 participants (Anticipated)Interventional2014-12-31Not yet recruiting
A Randomized Phase 1 Trial Evaluating the Safety of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma [NCT02344095]Phase 112 participants (Anticipated)Interventional2014-12-31Recruiting
A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers [NCT01659554]Phase 24 participants (Actual)Interventional2012-03-31Terminated(stopped due to Principal Investigator left institution)
Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC) [NCT02276560]Phase 21 participants (Actual)Interventional2015-01-31Terminated(stopped due to This study was terminated due to lack of funding.)
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma [NCT05984342]Phase 150 participants (Anticipated)Interventional2023-08-02Recruiting
UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma Ages 65 and Under: A Trial Enrolling Subjects to Standard Total Therapy 3 (S-TT3) [NCT00734877]Phase 3382 participants (Actual)Interventional2008-07-31Active, not recruiting
Phase II Study of De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma [NCT01530997]Phase 245 participants (Actual)Interventional2012-02-07Completed
A Phase I Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy [NCT01998529]Phase 17 participants (Actual)Interventional2014-08-20Completed
Salvage Immunotherapy Combined With Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy (SINCERE Study) [NCT05103501]Phase 254 participants (Anticipated)Interventional2021-12-01Not yet recruiting
A Phase 2 Study of Combined Chemo-immunotherapy With Cisplatin-pembrolizumab and Radiation for Unresectable Vulvar Squamous Cell Carcinoma [NCT04430699]Phase 224 participants (Anticipated)Interventional2020-07-29Recruiting
A Prospective, Multicenter, Open Label Phase â…¡ Clinical Trial of Doxorubicin Hydrochloride Liposome Injection Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma [NCT03387943]Phase 230 participants (Anticipated)Interventional2017-03-06Recruiting
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial [NCT04436965]Phase 3266 participants (Anticipated)Interventional2021-08-16Recruiting
A Phase III Trial Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy With Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer [NCT03366883]Phase 3420 participants (Anticipated)Interventional2018-02-01Not yet recruiting
Phase II Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer [NCT05305131]Phase 250 participants (Anticipated)Interventional2022-03-28Not yet recruiting
An Open-Label, Phase III Study of Platinum-Gemcitabine With or Without Nivolumab in the First-Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT04458909]Phase 315 participants (Actual)Interventional2020-12-09Terminated(stopped due to External information)
A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls [NCT01453660]44 participants (Anticipated)Observational2011-10-11Active, not recruiting
Randomized Phase II Trial Contrasting Weekly Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma [NCT01154920]Phase 2128 participants (Anticipated)Interventional2010-07-09Active, not recruiting
A Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of the Head and Neck [NCT01275183]Early Phase 15 participants (Actual)Interventional2010-12-31Completed
4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation Versus Concurrent Chemoradiation Alone In Patients With Stage N2-3 Nasopharyngeal Carcinoma: A Phase 3 Multicenter Randomised Controlled Trial [NCT02512315]Phase 3192 participants (Anticipated)Interventional2015-08-31Recruiting
A Randomized Trial Comparing Induction Gemcitabine and Cisplatin Plus Intensity-modulated Radiotherapy With Concurrent Cisplatin Plus Intensity-modulated Radiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT02460887]Phase 3236 participants (Anticipated)Interventional2015-06-30Active, not recruiting
An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 and Cisplatin Compared With 5-FU and Cisplatin in Patients With Metastatic Diffuse Gastric Cancer Previously Untreated With Chemotherapy [NCT01285557]Phase 3361 participants (Actual)Interventional2011-04-14Terminated(stopped due to Due to significant changes in investigational and clinical practice landscape of frontline advanced gastric cancer, which challenged viability of trial and increased use of modified chemotherapeutic triplets led to slow participant accrual in study.)
A Prospective Phase II Study of Radiation Therapy and Concurrent Cisplatin Chemotherapy in the Treatment of Locally Advanced or Metastatic Malignant Melanoma [NCT00707161]Phase 26 participants (Actual)Interventional2005-09-30Terminated(stopped due to discontinued due to low enrollment)
PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer [NCT02299999]Phase 21,460 participants (Actual)Interventional2014-04-07Active, not recruiting
Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer: An Open-lable, Single-arm, Exploratory Clinical Study [NCT03946969]Phase 230 participants (Actual)Interventional2019-05-09Active, not recruiting
A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-over Study to Evaluate the Effect of AF-219 on Methacholine Hyper-Reactivity in Subjects With Asthma [NCT01993329]Phase 220 participants (Actual)Interventional2013-12-16Completed
A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma [NCT02358863]13 participants (Actual)Interventional2015-02-28Terminated(stopped due to Issues with recruitment.)
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2) [NCT01459484]Phase 2225 participants (Anticipated)Interventional2011-06-23Active, not recruiting
The Effectiveness and Safety of Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma [NCT03964753]Phase 2202 participants (Anticipated)Interventional2019-04-24Recruiting
A Randomized Phase III Non-inferiority Study of Induction Chemotherapy Followed by IMRT Alone Versus Induction Chemotherapy Followed by IMRT Plus Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma [NCT02434614]Phase 3440 participants (Actual)Interventional2015-03-31Active, not recruiting
Phase III Study to Evaluate the Optimal Timing of Postoperative Radiotherapy for High Risk of Locoregional Recurrence Patients With Completely Resected Stage IIIA(N2) Non-Small Cell Lung Cancer [NCT02974426]Phase 31,094 participants (Anticipated)Interventional2016-11-30Recruiting
A Randomized, Controlled Phase II Study to Compare Irinotecan Combined With Cisplatin (IP) Versus Etoposide Combined With Cisplatin (EP) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Carcinoma [NCT03168594]Phase 266 participants (Actual)Interventional2017-04-29Terminated(stopped due to The enrollment was terminated early because the premature analysis found similar response in the two arms.)
A Phase I Dose-finding Study of Metformin in Combination With Concurrent Cisplatin and Radiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma [NCT02325401]Phase 120 participants (Actual)Interventional2015-05-11Completed
Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma [NCT05357846]Phase 3422 participants (Anticipated)Interventional2022-11-01Recruiting
Expanded Access Protocol With ABT-888 (Veliparib) in Patients With Metastatic BRCA-Mutation Associated or Triple Negative Breast Cancer [NCT02985658]0 participants Expanded AccessNo longer available
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00003298 (4) [back to overview]Best Confirmed Response to Neoadjuvant Therapy
NCT00003298 (4) [back to overview]Progression Free Survival
NCT00003298 (4) [back to overview]Grade 3 or Higher Toxicity Incidence on Step 1
NCT00003298 (4) [back to overview]Overall Survival
NCT00003377 (3) [back to overview]Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment
NCT00003377 (3) [back to overview]Overall Survival at 2 Years
NCT00003377 (3) [back to overview]Disease-free Survival at 2 Years
NCT00003907 (3) [back to overview]Time to Progression
NCT00003907 (3) [back to overview]Overall Survival
NCT00003907 (3) [back to overview]Tumor Response
NCT00004547 (2) [back to overview]Number of Participants With Adverse Events
NCT00004547 (2) [back to overview]Number of Participants With a Response
NCT00025259 (4) [back to overview]Disease Response Assessed by Modified RECIST Criteria
NCT00025259 (4) [back to overview]Grade 3 or 4 Non-hematologic Toxicity
NCT00025259 (4) [back to overview]Event-free Survival
NCT00025259 (4) [back to overview]Overall Survival
NCT00033657 (3) [back to overview]Overall Survival Time
NCT00033657 (3) [back to overview]Pathologic Complete Response Rate
NCT00033657 (3) [back to overview]Recurrence-free Survival Time
NCT00047008 (10) [back to overview]Disease-free Survival (Percentage of Participants Alive Without Disease)
NCT00047008 (10) [back to overview]Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year
NCT00047008 (10) [back to overview]Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]
NCT00047008 (10) [back to overview]Local-regional Failure (Percentage of Participants With Local-regional Failure)
NCT00047008 (10) [back to overview]Overall Survival (Percentage of Participants Alive)
NCT00047008 (10) [back to overview]Percentage of Participants With Toxicity Grade 3 or Higher
NCT00047008 (10) [back to overview]PSS-HN Understandability of Speech Score - AUC at One Year
NCT00047008 (10) [back to overview]PSS-HN Public Eating Score - AUC at One Year
NCT00047008 (10) [back to overview]Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]
NCT00047008 (10) [back to overview]Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year
NCT00057837 (3) [back to overview]Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)
NCT00057837 (3) [back to overview]Duration of Response
NCT00057837 (3) [back to overview]Overall Survival
NCT00062374 (2) [back to overview]Disease Free Survival (DFS)
NCT00062374 (2) [back to overview]Histological Response Determined by FDG Uptake Correlates
NCT00063999 (3) [back to overview]Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection
NCT00063999 (3) [back to overview]Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
NCT00063999 (3) [back to overview]Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
NCT00064077 (5) [back to overview]Pain, Assessed by Brief Pain Inventory
NCT00064077 (5) [back to overview]Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
NCT00064077 (5) [back to overview]Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
NCT00064077 (5) [back to overview]Duration of Overall Survival (OS)
NCT00064077 (5) [back to overview]Duration of Progression-free Survival (PFS)
NCT00068406 (2) [back to overview]Complete Clinical and Pathologic Response
NCT00068406 (2) [back to overview]Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
NCT00068575 (1) [back to overview]Median Overall Survival (OS)
NCT00083122 (3) [back to overview]Overall Survival
NCT00083122 (3) [back to overview]Time to Progression
NCT00083122 (3) [back to overview]Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)
NCT00083551 (1) [back to overview]Overall Survival
NCT00084838 (19) [back to overview]Pre-Radiation Therapy Chemotherapeutic Response
NCT00084838 (19) [back to overview]Grade 3-4 Hepatic Events
NCT00084838 (19) [back to overview]Grade 3-4 Hemorrhage Events
NCT00084838 (19) [back to overview]Grade 3-4 Dermatology Events
NCT00084838 (19) [back to overview]Grade 3-4 Gastrointestinal Events
NCT00084838 (19) [back to overview]Grade 3-4 Constitutional Events
NCT00084838 (19) [back to overview]Grade 3-4 Cardiovascular Events
NCT00084838 (19) [back to overview]Grade 3-4 Blood/Bone Marrow Events
NCT00084838 (19) [back to overview]Grade 3-4 Auditory/Hearing Events
NCT00084838 (19) [back to overview]Grade 3-4 Allergy/Immunology
NCT00084838 (19) [back to overview]2-yr Overall Survival
NCT00084838 (19) [back to overview]Grade 3/4 Events
NCT00084838 (19) [back to overview]Grade 3-4 Renal/Genitourinary Events
NCT00084838 (19) [back to overview]Grade 3-4 Pulmonary Events
NCT00084838 (19) [back to overview]Grade 3-4 Pain Events
NCT00084838 (19) [back to overview]Grade 3-4 Neurology Events
NCT00084838 (19) [back to overview]Grade 3-4 Muscloskeletal Events
NCT00084838 (19) [back to overview]Grade 3-4 Metabolic/Laboratory Events
NCT00084838 (19) [back to overview]Grade 3-4 Infection/Febrile Neutropenia Events
NCT00085098 (4) [back to overview]Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
NCT00085098 (4) [back to overview]Quality of Life (QOL) and Neurocognitive Assessment (NP)
NCT00085098 (4) [back to overview]Event-free Survival
NCT00085098 (4) [back to overview]Number of Participants With a Response to Regimen B
NCT00085735 (22) [back to overview]Event-free Survival (EFS)
NCT00085735 (22) [back to overview]Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
NCT00085735 (22) [back to overview]Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)
NCT00085735 (22) [back to overview]Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).
NCT00085735 (22) [back to overview]Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
NCT00085735 (22) [back to overview]Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)
NCT00085735 (22) [back to overview]Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)
NCT00085735 (22) [back to overview]Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
NCT00085735 (22) [back to overview]Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays
NCT00085735 (22) [back to overview]Overall Survival (OS)
NCT00085735 (22) [back to overview]Overall Survival (OS)
NCT00085735 (22) [back to overview]Event-free Survival (EFS)
NCT00085735 (22) [back to overview]Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)
NCT00085735 (22) [back to overview]Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)
NCT00085735 (22) [back to overview]Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group
NCT00085735 (22) [back to overview]Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
NCT00085735 (22) [back to overview]Local Posterior Fossa (LPF) Failure Rate
NCT00085735 (22) [back to overview]Non-local Posterior Fossa (NLPF) Failure Rate
NCT00085735 (22) [back to overview]Non-posterior Fossa (NPF) Failure Rate
NCT00085735 (22) [back to overview]Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays
NCT00085735 (22) [back to overview]Post-treatment Endocrine Function by CSI Group
NCT00085735 (22) [back to overview]Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)
NCT00096174 (3) [back to overview]2-year Progression-free Survival Rate
NCT00096174 (3) [back to overview]2-year Overall Survival Rate
NCT00096174 (3) [back to overview]Overall Response Rate
NCT00101582 (8) [back to overview]Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment
NCT00101582 (8) [back to overview]Number of Participants With Unplanned Breaks in Radiotherapy
NCT00101582 (8) [back to overview]Patient-Reported Mouth and Throat Soreness Score
NCT00101582 (8) [back to overview]Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis
NCT00101582 (8) [back to overview]Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks
NCT00101582 (8) [back to overview]Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
NCT00101582 (8) [back to overview]Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)
NCT00101582 (8) [back to overview]Duration of Severe (WHO Grade 3 or 4) Oral Mucositis
NCT00102531 (1) [back to overview]The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
NCT00122460 (9) [back to overview]Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
NCT00122460 (9) [back to overview]Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
NCT00122460 (9) [back to overview]Best Overall Response
NCT00122460 (9) [back to overview]Disease Control
NCT00122460 (9) [back to overview]Duration of Response
NCT00122460 (9) [back to overview]Overall Survival Time (OS)
NCT00122460 (9) [back to overview]Progression-free Survival Time (PFS)
NCT00122460 (9) [back to overview]Safety - Number of Patients Experiencing Any Adverse Event
NCT00122460 (9) [back to overview]Time to Treatment Failure
NCT00134030 (3) [back to overview]Percentage of Patients With Overall Survival
NCT00134030 (3) [back to overview]Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0
NCT00134030 (3) [back to overview]Event-free Survival (EFS)
NCT00143455 (5) [back to overview]Duration of Response (DR)
NCT00143455 (5) [back to overview]Number of Subjects With Overall Confirmed Response
NCT00143455 (5) [back to overview]Overall Survival (OS) for the Full Analysis Population (FAP)
NCT00143455 (5) [back to overview]Overall Survival for the Per Protocol (PP) Population
NCT00143455 (5) [back to overview]Time to Tumor Progression (TTP)
NCT00148798 (8) [back to overview]Disease Control Rate
NCT00148798 (8) [back to overview]Best Overall Response Rate
NCT00148798 (8) [back to overview]A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations
NCT00148798 (8) [back to overview]Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
NCT00148798 (8) [back to overview]Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
NCT00148798 (8) [back to overview]Safety - Number of Patients Experiencing Any Adverse Event
NCT00148798 (8) [back to overview]Progression-free Survival Time
NCT00148798 (8) [back to overview]Overall Survival Time (OS)
NCT00191139 (5) [back to overview]2-Year Survival
NCT00191139 (5) [back to overview]Number of Patients With Overall Tumor Response
NCT00191139 (5) [back to overview]Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization
NCT00191139 (5) [back to overview]Progression-Free Survival
NCT00191139 (5) [back to overview]Overall Survival
NCT00253370 (3) [back to overview]Progression-free Survival (PFS)
NCT00253370 (3) [back to overview]The Proportion of Patients With Objective Response (Complete Response or Partial Response)
NCT00253370 (3) [back to overview]Overall Survival (OS)
NCT00262951 (2) [back to overview]Number of Patients in Whom Tumor Was Resectable
NCT00262951 (2) [back to overview]Overall Survival
NCT00274937 (3) [back to overview]Two Year Event-free Survival (EFS)
NCT00274937 (3) [back to overview]Protective Effects of Amifostine Assessed Primarily by Sialometry
NCT00274937 (3) [back to overview]Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.
NCT00304070 (7) [back to overview]Complications Associated With Radical Adrenalectomy and RLND
NCT00304070 (7) [back to overview]Five Year Event-free Survival (EFS)
NCT00304070 (7) [back to overview]Frequency of Lymph Node Involvement by Imaging.
NCT00304070 (7) [back to overview]Frequency of Tumor Spillage at the Time of Tumor Resection
NCT00304070 (7) [back to overview]Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.
NCT00304070 (7) [back to overview]Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.
NCT00304070 (7) [back to overview]Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT00304278 (1) [back to overview]Survival Post Treatment
NCT00316888 (5) [back to overview]3-year Colostomy-free Survival Rate
NCT00316888 (5) [back to overview]3-year Overall Survival Rate
NCT00316888 (5) [back to overview]Local Failure Rate at 3 Years
NCT00316888 (5) [back to overview]Objective Response Rate
NCT00316888 (5) [back to overview]3-year Progression-free Survival Rate
NCT00324805 (2) [back to overview]Disease-free Survival
NCT00324805 (2) [back to overview]Overall Survival
NCT00331760 (9) [back to overview]Rate of Overall Survival at Five Years
NCT00331760 (9) [back to overview]Rate of Local-regional Failure at Five Years
NCT00331760 (9) [back to overview]Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
NCT00331760 (9) [back to overview]Percentage of Patients With Grade 2+ Bowel Adverse Events
NCT00331760 (9) [back to overview]Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
NCT00331760 (9) [back to overview]Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
NCT00331760 (9) [back to overview]Rate of Distant Metastases at Five Years
NCT00331760 (9) [back to overview]Rate of Disease-free Survival at Five Years
NCT00331760 (9) [back to overview]Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
NCT00334815 (4) [back to overview]Overall Survival
NCT00334815 (4) [back to overview]Progression-free Survival
NCT00334815 (4) [back to overview]Adverse Events
NCT00334815 (4) [back to overview]Response Rate (Confirmed or Unconfirmed Partial Response)
NCT00336024 (10) [back to overview]Number of Participants With Chronic Central Hypothyroidism
NCT00336024 (10) [back to overview]Number of Participants With Chronic Diabetes Insipidus
NCT00336024 (10) [back to overview]Number of Participants With Chronic Low Somatomedin C
NCT00336024 (10) [back to overview]Rates of Nutritional Toxicities
NCT00336024 (10) [back to overview]Rates of Gastrointestinal Toxicities
NCT00336024 (10) [back to overview]Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).
NCT00336024 (10) [back to overview]Percentage of Participants With Event Free Survival (EFS)
NCT00336024 (10) [back to overview]Percentage of Participants With Any Acute Adverse Events
NCT00336024 (10) [back to overview]Number of Participants With Secondary Malignancies
NCT00336024 (10) [back to overview]Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism
NCT00360971 (6) [back to overview]Duration of Oral Mucositis as Measured in Terms of Days
NCT00360971 (6) [back to overview]Time to Second Primary Tumor
NCT00360971 (6) [back to overview]Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale
NCT00360971 (6) [back to overview]Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale
NCT00360971 (6) [back to overview]Progression-free Survival
NCT00360971 (6) [back to overview]Overall Survival
NCT00369122 (4) [back to overview]Overall Survival (Three-year Rate Reported)
NCT00369122 (4) [back to overview]Disease-free Survival (Three-year Rate Reported)
NCT00369122 (4) [back to overview]Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.
NCT00369122 (4) [back to overview]Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.
NCT00381706 (5) [back to overview]Overall Survival in Patients With Adenocarcinoma
NCT00381706 (5) [back to overview]Progression-free Survival in Patients With Adenocarcinoma
NCT00381706 (5) [back to overview]Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma
NCT00381706 (5) [back to overview]Time to Treatment Failure in Patients With Adenocarcinoma
NCT00381706 (5) [back to overview]Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma
NCT00388154 (2) [back to overview]Overall Objective Response Rate (CR + PR)
NCT00388154 (2) [back to overview]Participant Responses
NCT00392327 (14) [back to overview]The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for SPNET Patients
NCT00392327 (14) [back to overview]The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for SPNET Patients
NCT00392327 (14) [back to overview]Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma
NCT00392327 (14) [back to overview]Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
NCT00392327 (14) [back to overview]Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma
NCT00392327 (14) [back to overview]Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
NCT00392327 (14) [back to overview]Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
NCT00392327 (14) [back to overview]The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients
NCT00392327 (14) [back to overview]Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
NCT00392327 (14) [back to overview]Tumor Response to Radiation Therapy for Patients With Medulloblastoma
NCT00392327 (14) [back to overview]Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients
NCT00392327 (14) [back to overview]Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for SPNET Patients
NCT00392327 (14) [back to overview]The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
NCT00392327 (14) [back to overview]Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for SPNET Patients
NCT00394433 (4) [back to overview]10-month Progression-Free Survival Rate
NCT00394433 (4) [back to overview]Overall Survival
NCT00394433 (4) [back to overview]Best Response
NCT00394433 (4) [back to overview]Progression-Free Survival
NCT00400179 (5) [back to overview]Time to Treatment Failure (TTF)
NCT00400179 (5) [back to overview]Progression-free Survival (PFS)
NCT00400179 (5) [back to overview]Overall Response Rate (ORR)
NCT00400179 (5) [back to overview]Median Survival
NCT00400179 (5) [back to overview]Duration of Response (DR)
NCT00408694 (9) [back to overview]Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment
NCT00408694 (9) [back to overview]One- and Two-year Distant Metastases-free Rates
NCT00408694 (9) [back to overview]One- and Two-year Loco-regional Progression-free Rates
NCT00408694 (9) [back to overview]Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen
NCT00408694 (9) [back to overview]Death During or Within 30 Days of Discontinuation of Protocol Treatment.
NCT00408694 (9) [back to overview]One- and Two-year Progression-free Survival Rates
NCT00408694 (9) [back to overview]Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.
NCT00408694 (9) [back to overview]Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.
NCT00408694 (9) [back to overview]One- and Two-year Overall Survival Rates
NCT00453154 (4) [back to overview]Number of Participants With Overall Tumor Response
NCT00453154 (4) [back to overview]Progression-free Survival (Phase II)
NCT00453154 (4) [back to overview]Overall Survival
NCT00453154 (4) [back to overview]Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)
NCT00454636 (6) [back to overview]Time to Response
NCT00454636 (6) [back to overview]Progression-Free Survival (PFS)
NCT00454636 (6) [back to overview]Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
NCT00454636 (6) [back to overview]Overall Survival (OS)
NCT00454636 (6) [back to overview]Duration of Response
NCT00454636 (6) [back to overview]Overall Response Rate (ORR)
NCT00454649 (34) [back to overview]Apparent Oral Clearance (CL/F) for Capecitabine
NCT00454649 (34) [back to overview]Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Carboplatin
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Pemetrexed
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Paclitaxel
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Gemcitabine
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Docetaxel
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Cisplatin
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Carboplatin
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Capecitabine
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Pemetrexed
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Paclitaxel
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Gemcitabine
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Docetaxel
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Cisplatin
NCT00454649 (34) [back to overview]Percentage of Participants With Objective Response
NCT00454649 (34) [back to overview]Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Pemetrexed
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Paclitaxel
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Gemcitabine
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Docetaxel
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Cisplatin
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Carboplatin
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Capecitabine
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin
NCT00454779 (12) [back to overview]Duration of Response (DOR) During the Second-line Treatment Phase
NCT00454779 (12) [back to overview]Overall Survival (OS) for the Second-line Treatment
NCT00454779 (12) [back to overview]Progression Free Survival (PFS) During the First-line Treatment Phase
NCT00454779 (12) [back to overview]Progression Free Survival (PFS) During the Second-line Treatment Phase
NCT00454779 (12) [back to overview]Overall Response Rate (ORR) During the Second-line Treatment Phase
NCT00454779 (12) [back to overview]Rate of Disease Control (RDC) During the First-line Treatment Phase
NCT00454779 (12) [back to overview]Rate of Disease Control (RDC) During the Second-line Treatment Phase
NCT00454779 (12) [back to overview]Time to Response (TTR) During the First-line Treatment Phase
NCT00454779 (12) [back to overview]Duration of Response (DOR) During the First-line Treatment Phase
NCT00454779 (12) [back to overview]Time to Response (TTR) During the Second-line Treatment Phase
NCT00454779 (12) [back to overview]Overall Survival (OS) for the First-line Treatment
NCT00454779 (12) [back to overview]Overall Response Rate (ORR) During the First-line Treatment Phase
NCT00463788 (5) [back to overview]Best Overall Response (BOR)
NCT00463788 (5) [back to overview]Overall Survival (OS) Time
NCT00463788 (5) [back to overview]Progression-Free Survival (PFS) Time
NCT00463788 (5) [back to overview]Safety- Number of Participants Experiencing Any Adverse Event (AE)
NCT00463788 (5) [back to overview]Time to Response (TTR)
NCT00492778 (4) [back to overview]Number of Participants That Experienced Adverse Effects Grade 3 or Higher
NCT00492778 (4) [back to overview]Number of Participants That Experienced Death on Study
NCT00492778 (4) [back to overview]Number of Participants With Disease Progression or Death.
NCT00492778 (4) [back to overview]Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.
NCT00505635 (1) [back to overview]Time to Progression (TTP)
NCT00506155 (2) [back to overview]Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen
NCT00506155 (2) [back to overview]5-year Overall Survival (OS)
NCT00509366 (3) [back to overview]Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
NCT00509366 (3) [back to overview]1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients
NCT00509366 (3) [back to overview]Median Time to Progressive Disease
NCT00511992 (2) [back to overview]Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
NCT00511992 (2) [back to overview]Number of Patients Able to Complete 6 Cycles of Treatment.
NCT00512096 (1) [back to overview]Number of Participants With Pathologic Complete Remission (pCR)
NCT00515411 (2) [back to overview]6 Month Progression Free Survival (PFS)
NCT00515411 (2) [back to overview]Overall Survival
NCT00522795 (1) [back to overview]Complete Pathologic Response
NCT00529100 (9) [back to overview]Phase 2: Time to Progressive Disease (PD)
NCT00529100 (9) [back to overview]Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year
NCT00529100 (9) [back to overview]Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
NCT00529100 (9) [back to overview]Phase 2: Site of Progressive Disease (PD)
NCT00529100 (9) [back to overview]Phase 2: Percentage of Participants With Progression Free Survival (PFS)
NCT00529100 (9) [back to overview]Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years
NCT00529100 (9) [back to overview]Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)
NCT00529100 (9) [back to overview]Phase 1: Number of Participants With Adverse Events (AE; Toxicity)
NCT00529100 (9) [back to overview]Progression Free Survival (PFS)
NCT00545948 (3) [back to overview]Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy
NCT00545948 (3) [back to overview]2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC
NCT00545948 (3) [back to overview]2-Year Overall Survival in Patients Treated for NSCLC
NCT00547157 (6) [back to overview]ORR by 6 Months - Central
NCT00547157 (6) [back to overview]Overall Survival
NCT00547157 (6) [back to overview]Local Regional Control Rate at 2 Years
NCT00547157 (6) [back to overview]Progression-free Survival
NCT00547157 (6) [back to overview]Duration of Local Regional Control
NCT00547157 (6) [back to overview]CRR by 6 Months - Central
NCT00554788 (3) [back to overview]Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT00554788 (3) [back to overview]Response Rate to the Induction Phase of the Regimen
NCT00554788 (3) [back to overview]Event-free Survival (EFS)
NCT00566540 (2) [back to overview]Percentage of Participants With Serious Adverse Events
NCT00566540 (2) [back to overview]Treatment Completion
NCT00567567 (14) [back to overview]Incidence Rate of Local Recurrence
NCT00567567 (14) [back to overview]Intraspinal Extension
NCT00567567 (14) [back to overview]OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology
NCT00567567 (14) [back to overview]Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
NCT00567567 (14) [back to overview]Event-free Survival Rate
NCT00567567 (14) [back to overview]Proportion of Patients With a Polymorphism
NCT00567567 (14) [back to overview]Response After Induction Therapy
NCT00567567 (14) [back to overview]Surgical Response
NCT00567567 (14) [back to overview]Topotecan Systemic Clearance
NCT00567567 (14) [back to overview]Duration of Greater Than or Equal to Grade 3 Neutropenia
NCT00567567 (14) [back to overview]Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells
NCT00567567 (14) [back to overview]EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).
NCT00567567 (14) [back to overview]Type of Surgical or Radiotherapy Complication
NCT00567567 (14) [back to overview]Duration of Greater Than or Equal to Grade 3 Thrombocytopenia
NCT00573131 (1) [back to overview]Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT
NCT00577096 (10) [back to overview]Total Number of Days of Stem Cell Collection (Short Term)
NCT00577096 (10) [back to overview]Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
NCT00577096 (10) [back to overview]Total Number of Days of Stem Cell Collection (Long Term)
NCT00577096 (10) [back to overview]Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
NCT00577096 (10) [back to overview]Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
NCT00577096 (10) [back to overview]Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
NCT00577096 (10) [back to overview]Number of Stem Cell Collection Attempts (Long Term)
NCT00577096 (10) [back to overview]Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
NCT00577096 (10) [back to overview]Number of Stem Cell Collection Attempts (Short Term)
NCT00577096 (10) [back to overview]Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
NCT00582205 (2) [back to overview]Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
NCT00582205 (2) [back to overview]Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
NCT00588770 (3) [back to overview]Progression-free Survival (PFS)
NCT00588770 (3) [back to overview]Overall Survival (OS)
NCT00588770 (3) [back to overview]Overall Response Rate
NCT00590967 (3) [back to overview]Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
NCT00590967 (3) [back to overview]Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
NCT00590967 (3) [back to overview]Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 4
NCT00602667 (62) [back to overview]Pharmacogenetic Variation on Central Nervous System Transmitters
NCT00602667 (62) [back to overview]Numbers of Patients With Molecular Abnormalities by Tumor Type
NCT00602667 (62) [back to overview]Numbers of Patients With Gene Alterations
NCT00602667 (62) [back to overview]Number of Successful Collections for Frozen and Fixed Tumor Samples
NCT00602667 (62) [back to overview]Number of Participants With Chromosomal Abnormalities
NCT00602667 (62) [back to overview]Number and Type of Genetic Polymorphisms
NCT00602667 (62) [back to overview]Concentration of Cerebrospinal Fluid Neurotransmitters
NCT00602667 (62) [back to overview]Topotecan Clearance in Consolidation Chemotherapy
NCT00602667 (62) [back to overview]Topotecan AUC0-24h in Maintenance Chemotherapy
NCT00602667 (62) [back to overview]Topotecan AUC0-24h in Consolidation Chemotherapy
NCT00602667 (62) [back to overview]Topotecan Apparent Oral Clearance in Maintenance Chemotherapy
NCT00602667 (62) [back to overview]Rate of Local Disease Progression
NCT00602667 (62) [back to overview]Rate of Distant Disease Progression
NCT00602667 (62) [back to overview]Percentage of Patients With Objective Responses Rate to Induction Chemotherapy
NCT00602667 (62) [back to overview]Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup
NCT00602667 (62) [back to overview]Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients
NCT00602667 (62) [back to overview]Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients
NCT00602667 (62) [back to overview]Percent of PET Scans With Loss of Signal Intensity
NCT00602667 (62) [back to overview]Percent of Patients With Sustained Objective Responses Rate After Consolidation
NCT00602667 (62) [back to overview]Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan
NCT00602667 (62) [back to overview]Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan
NCT00602667 (62) [back to overview]Overall Survival (OS) Compared to Historical Controls
NCT00602667 (62) [back to overview]OSI-420 AUC0-24h
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 2
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 1
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 4
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 2
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 1
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 4
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 2
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 1
NCT00602667 (62) [back to overview]Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
NCT00602667 (62) [back to overview]Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
NCT00602667 (62) [back to overview]Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
NCT00602667 (62) [back to overview]Event-free Survival (EFS) Compared to Historical Controls
NCT00602667 (62) [back to overview]Erlotinib AUC0-24h
NCT00602667 (62) [back to overview]Erlotinib Apparent Volume of Central Compartment
NCT00602667 (62) [back to overview]Erlotinib Apparent Oral Clearance
NCT00602667 (62) [back to overview]Cyclophosphamide Clearance in Induction Chemotherapy
NCT00602667 (62) [back to overview]Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00603408 (4) [back to overview]Overall Response
NCT00603408 (4) [back to overview]Number of Participants With Medical Toxicities
NCT00603408 (4) [back to overview]Number of Participants With Surgical Complications
NCT00603408 (4) [back to overview]Overall Survival Rate (OS)
NCT00626639 (3) [back to overview]Number of Participants With Disease Progression by Week 12
NCT00626639 (3) [back to overview]Number of Participants With Adverse Events (AEs)
NCT00626639 (3) [back to overview]Overall Survival
NCT00639769 (2) [back to overview]Number of Patients With Each Worst-grade Toxicity
NCT00639769 (2) [back to overview]Patient Response
NCT00653068 (4) [back to overview]Event-free Survival
NCT00653068 (4) [back to overview]Overall Survival (OS)
NCT00653068 (4) [back to overview]Toxic Death
NCT00653068 (4) [back to overview]Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 2
NCT00659269 (4) [back to overview]Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 4
NCT00700336 (1) [back to overview]4M PFS Rate of Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma (MPM) Treated With CBP501, Pemetrexed and Cisplatin
NCT00702299 (6) [back to overview]Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)
NCT00702299 (6) [back to overview]Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose
NCT00702299 (6) [back to overview]Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed
NCT00702299 (6) [back to overview]Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125
NCT00702299 (6) [back to overview]Overall Survival
NCT00702299 (6) [back to overview]Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)
NCT00736944 (21) [back to overview]Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan
NCT00736944 (21) [back to overview]Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT
NCT00736944 (21) [back to overview]Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT
NCT00736944 (21) [back to overview]Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy
NCT00736944 (21) [back to overview]Disease Free Survival
NCT00736944 (21) [back to overview]Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT
NCT00736944 (21) [back to overview]Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria
NCT00736944 (21) [back to overview]Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy
NCT00736944 (21) [back to overview]Clinical Partial Response Rate at the Primary Tumor
NCT00736944 (21) [back to overview]Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria
NCT00736944 (21) [back to overview]Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy
NCT00736944 (21) [back to overview]Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria
NCT00736944 (21) [back to overview]Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy
NCT00736944 (21) [back to overview]Clinical Complete Response Rate at the Primary Tumor
NCT00736944 (21) [back to overview]Overall Complete and Partial Response Rates by FDG Uptake on PET Scan
NCT00736944 (21) [back to overview]Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan
NCT00736944 (21) [back to overview]Clinical Overall Complete and Partial Response Rates
NCT00736944 (21) [back to overview]Clinical Complete and Partial Response Rates to the Involved Regional Nodes
NCT00736944 (21) [back to overview]Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
NCT00736944 (21) [back to overview]Time to Progression
NCT00736944 (21) [back to overview]Overall Survival
NCT00742924 (1) [back to overview]Limiting Toxicity
NCT00770874 (2) [back to overview]Overall Survival
NCT00770874 (2) [back to overview]Progression Free Survival, Safety
NCT00777491 (6) [back to overview]Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events
NCT00777491 (6) [back to overview]Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy
NCT00777491 (6) [back to overview]Number of Participants With Progression or Removal of Bladder Five Years After Therapy
NCT00777491 (6) [back to overview]Percentage of Patients Without Distant Metastases by Three Years
NCT00777491 (6) [back to overview]Change in American Urological Association Symptom Index (AUASI) Score at 3 Years
NCT00777491 (6) [back to overview]Percentage of Patients Who Completed Treatment Per Protocol
NCT00798655 (2) [back to overview]Probability of 2-year Overall Survival
NCT00798655 (2) [back to overview]Probability of Progression-free Survival (PFS) at 2 Years
NCT00803062 (4) [back to overview]To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
NCT00803062 (4) [back to overview]Progression-free Survival
NCT00803062 (4) [back to overview]Overall Survival
NCT00803062 (4) [back to overview]Tumor Response
NCT00832117 (5) [back to overview]Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00832117 (5) [back to overview]Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
NCT00832117 (5) [back to overview]Participants Experiencing Dose Limiting Toxicity (DLT)
NCT00832117 (5) [back to overview]Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2
NCT00832117 (5) [back to overview]Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
NCT00842712 (6) [back to overview]Randomized Part: Progression Free Survival (PFS) Time - Independent Read
NCT00842712 (6) [back to overview]Randomized Part: Overall Survival (OS) Time
NCT00842712 (6) [back to overview]Randomized Part: Best Overall Response (BOR) Rate
NCT00842712 (6) [back to overview]Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)
NCT00842712 (6) [back to overview]Randomized Part: Time to Treatment Failure
NCT00842712 (6) [back to overview]Randomized Part: Progression Free Survival (PFS) Time - Investigator Read
NCT00882583 (1) [back to overview]MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B
NCT00887159 (4) [back to overview]Progression-free Survival (PFS)
NCT00887159 (4) [back to overview]PFS
NCT00887159 (4) [back to overview]Response Rate
NCT00887159 (4) [back to overview]Overall Survival (OS)
NCT00911820 (5) [back to overview]Overall Response (OR) Rate
NCT00911820 (5) [back to overview]Progression-Free Survival
NCT00911820 (5) [back to overview]Best Response
NCT00911820 (5) [back to overview]Overall Survival
NCT00911820 (5) [back to overview]7-month Progression-Free Survival
NCT00942331 (4) [back to overview]Overall Survival (OS)
NCT00942331 (4) [back to overview]Number of Patients Experiencing Grade 3+ Toxicity
NCT00942331 (4) [back to overview]Objective Response
NCT00942331 (4) [back to overview]Progression-free Survival (PFS)
NCT00942357 (5) [back to overview]Patient-reported Peripheral Neuropathy Symptoms
NCT00942357 (5) [back to overview]Patient-reported Quality of Life (QOL)
NCT00942357 (5) [back to overview]Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
NCT00942357 (5) [back to overview]Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
NCT00942357 (5) [back to overview]Number of Participants With Recurrence, Progression or Death
NCT00942825 (1) [back to overview]The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.
NCT00951496 (7) [back to overview]Patient Reported Neurotoxicity (Ntx)
NCT00951496 (7) [back to overview]Median Progression-free Survival
NCT00951496 (7) [back to overview]Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
NCT00951496 (7) [back to overview]Patient Reported Quality of Life (QOL)
NCT00951496 (7) [back to overview]Overall Survival
NCT00951496 (7) [back to overview]Patient Reported Fatigue
NCT00951496 (7) [back to overview]Patient Reported Nausea
NCT00963807 (5) [back to overview]Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00963807 (5) [back to overview]Change in FLT Uptake in Responders and Non-responders
NCT00963807 (5) [back to overview]Change in FLT Uptake
NCT00963807 (5) [back to overview]Change in 18F-Fluorothymidine (FLT) Uptake
NCT00963807 (5) [back to overview]Change in 18F-Fluorodeoxyglucose (FDG) Uptake
NCT00968799 (4) [back to overview]Overall Survival
NCT00968799 (4) [back to overview]Fitness for Systemic Chemotherapy
NCT00968799 (4) [back to overview]Nephrotoxicity
NCT00968799 (4) [back to overview]Surgical Complications
NCT00977561 (1) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00980460 (5) [back to overview]Event-free Survival
NCT00980460 (5) [back to overview]Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed
NCT00980460 (5) [back to overview]Disease Status at the End of 2 Courses of Therapy
NCT00980460 (5) [back to overview]Number of Deaths
NCT00980460 (5) [back to overview]Feasibility of Referral for Liver Transplantation
NCT00995761 (1) [back to overview]Response Rates Confirmed With CT or MRI
NCT01004978 (4) [back to overview]Overall Survival (OS)
NCT01004978 (4) [back to overview]Progression-free Survival (PFS)
NCT01004978 (4) [back to overview]Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression
NCT01004978 (4) [back to overview]Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression
NCT01005329 (6) [back to overview]Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start
NCT01005329 (6) [back to overview]Pelvic Failure Rate (Two-year Rate Reported)
NCT01005329 (6) [back to overview]Overall Survival (Two-year Rate Reported)
NCT01005329 (6) [back to overview]Distant Failure (Two-year Rate Reported)
NCT01005329 (6) [back to overview]Disease-free Survival (Two-year Rate Reported)
NCT01005329 (6) [back to overview]Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start
NCT01009346 (2) [back to overview]Maximum Tolerated Dose (MTD) of RAD001 in Combination With Cetuximab and Cisplatin.
NCT01009346 (2) [back to overview]Progression Free Survival (PFS) of RAD001 in Combination With Weekly Cetuximab and Cisplatin.
NCT01042522 (3) [back to overview]Overall Survival (OS)
NCT01042522 (3) [back to overview]Progression-free Survival (PFS)
NCT01042522 (3) [back to overview]Tumor Response Rate
NCT01047007 (1) [back to overview]Number of Participants With Dose Limiting Toxicities (DLTs)
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts
NCT01055496 (17) [back to overview]Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2
NCT01055496 (17) [back to overview]Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1
NCT01055496 (17) [back to overview]Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts
NCT01055496 (17) [back to overview]Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy
NCT01055496 (17) [back to overview]Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy
NCT01055496 (17) [back to overview]Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts
NCT01055496 (17) [back to overview]Percentage of Participants With a Treatment Emergent AE
NCT01055496 (17) [back to overview]Mean Inotuzumab Ozogamicin Serum Concentrations
NCT01055496 (17) [back to overview]Mean Inotuzumab Ozogamicin Serum Concentrations
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts
NCT01064479 (5) [back to overview]Disease Control (CR + PR + Stable Disease [SD])
NCT01064479 (5) [back to overview]Overall Survival (OS)
NCT01064479 (5) [back to overview]Progression Free Survival (PFS)
NCT01064479 (5) [back to overview]Rash Rates
NCT01064479 (5) [back to overview]Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
NCT01064648 (9) [back to overview]Disease Control Rate by Modified RECIST (Phase II)
NCT01064648 (9) [back to overview]Disease Control Rate by RECIST 1.1 (Phase II)
NCT01064648 (9) [back to overview]Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)
NCT01064648 (9) [back to overview]Progression-free Survival (Phase II)
NCT01064648 (9) [back to overview]Response Rate by Modified RECIST (Phase II)
NCT01064648 (9) [back to overview]Response Rate by RECIST1.1 (Phase II)
NCT01064648 (9) [back to overview](Phase I) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT01064648 (9) [back to overview](Phase II) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT01064648 (9) [back to overview]Overall Survival (Phase II)
NCT01091454 (6) [back to overview]6-month Progression-free Survival (6-mo PFS) Rate
NCT01091454 (6) [back to overview]3-month Progression-free Survival (3-mo PFS) Rate
NCT01091454 (6) [back to overview]Confirmed Response Rate
NCT01091454 (6) [back to overview]Duration of Response
NCT01091454 (6) [back to overview]Time to Disease Progression
NCT01091454 (6) [back to overview]Survival Time
NCT01096368 (10) [back to overview]OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation
NCT01096368 (10) [back to overview]OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only.
NCT01096368 (10) [back to overview]EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation
NCT01096368 (10) [back to overview]EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy
NCT01096368 (10) [back to overview]EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy
NCT01133678 (1) [back to overview]Tumor Responses
NCT01151761 (8) [back to overview]Freedom From Local Progression at 12 Months
NCT01151761 (8) [back to overview]Liver Transplant Conversion Rate
NCT01151761 (8) [back to overview]Liver Transplant Rate
NCT01151761 (8) [back to overview]Median Time to Overall Survival
NCT01151761 (8) [back to overview]Overall Survival at 12 Months
NCT01151761 (8) [back to overview]Pathologic Complete Response Rate
NCT01151761 (8) [back to overview]Progression-free Survival at 12 Months
NCT01151761 (8) [back to overview]Serum CA 19-9 Levels
NCT01175356 (3) [back to overview]Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy
NCT01175356 (3) [back to overview]Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG
NCT01175356 (3) [back to overview]Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131
NCT01194453 (2) [back to overview]Progression Free Survival (PFS)
NCT01194453 (2) [back to overview]Response Rate
NCT01194869 (3) [back to overview]Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment
NCT01194869 (3) [back to overview]Clinical Response Rate (Complete Pathologic Response Rate After Surgery)
NCT01194869 (3) [back to overview]Clinical Response Rate During Follow-up (Disease Recurrence)
NCT01196416 (9) [back to overview]Progression-free Survival (Phase II)
NCT01196416 (9) [back to overview]Participants Evaluated for Toxicity
NCT01196416 (9) [back to overview]Maximum Tolerated Dose for RO4929097
NCT01196416 (9) [back to overview]Cycle 1 Mean Day 2 Trough/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)
NCT01196416 (9) [back to overview]Cycle 1 C Max/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)
NCT01196416 (9) [back to overview]Cycle 1 AUC/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)
NCT01196416 (9) [back to overview]Overall Survival (Phase II)
NCT01196416 (9) [back to overview]Number of Participants With Presence or Absence of Markers of Notch Signalling Pathway Inhibition in Patient Tumors (Phase Ib)
NCT01196416 (9) [back to overview]Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ
NCT01240590 (3) [back to overview]Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)
NCT01240590 (3) [back to overview]Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)
NCT01240590 (3) [back to overview]Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)
NCT01275664 (2) [back to overview]Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
NCT01275664 (2) [back to overview]Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)
NCT01277744 (2) [back to overview]Recurrence Free Survival
NCT01277744 (2) [back to overview]Overall Survival
NCT01285557 (8) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
NCT01285557 (8) [back to overview]Duration of Response (DR)
NCT01285557 (8) [back to overview]Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3
NCT01285557 (8) [back to overview]Overall Response Rate (ORR): Percentage of Participants With Overall Response
NCT01285557 (8) [back to overview]Overall Survival (OS)
NCT01285557 (8) [back to overview]Progression-free Survival (PFS)
NCT01285557 (8) [back to overview]Time to Treatment Failure (TTF)
NCT01285557 (8) [back to overview]Time to Tumor Response (TTR)
NCT01362127 (3) [back to overview]HRQOL and Swallowing Function
NCT01362127 (3) [back to overview]Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
NCT01362127 (3) [back to overview]Safety of Respective Neoadjuvant Therapies.
NCT01414608 (6) [back to overview]Progression-free Survival Rate at 5 Years
NCT01414608 (6) [back to overview]Overall Survival Rate at 5 Years
NCT01414608 (6) [back to overview]Quality of Life for Global Health Status
NCT01414608 (6) [back to overview]Number of Participants With Adverse Events (Grade 3 or Higher) in First Year
NCT01414608 (6) [back to overview]Patterns of Disease Recurrence
NCT01414608 (6) [back to overview]Radiation Protocol Compliance
NCT01530997 (10) [back to overview]Overall Survival Rate
NCT01530997 (10) [back to overview]Cause-Specific Survival
NCT01530997 (10) [back to overview]Distant Metastases Free Survival
NCT01530997 (10) [back to overview]Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).
NCT01530997 (10) [back to overview]European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
NCT01530997 (10) [back to overview]Regional Control
NCT01530997 (10) [back to overview]The Eating Assessment Tool (EAT-10) Composite Score
NCT01530997 (10) [back to overview]Two-Year Local Control
NCT01530997 (10) [back to overview]European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
NCT01530997 (10) [back to overview]The Rosenbek Penetration Aspiration Scale
NCT01590017 (2) [back to overview]Patients With Adverse Events
NCT01590017 (2) [back to overview]Treatment Completion Rate
NCT01595061 (4) [back to overview]Progression-free Survival (PFS)
NCT01595061 (4) [back to overview]Adverse Events (Grade 3 or Higher) During Treatment Period
NCT01595061 (4) [back to overview]Complete Pathologic Response
NCT01595061 (4) [back to overview]Complete Clinical Response
NCT01612351 (9) [back to overview]Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.
NCT01612351 (9) [back to overview]Overall Response Rate
NCT01612351 (9) [back to overview]Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL)
NCT01612351 (9) [back to overview]Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy
NCT01612351 (9) [back to overview]Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI)
NCT01612351 (9) [back to overview]Feasibility of 3 Part Therapy
NCT01612351 (9) [back to overview]Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
NCT01612351 (9) [back to overview]Response Rates at the Neck.
NCT01612351 (9) [back to overview]Response Rates at the Primary Site
NCT01642251 (5) [back to overview]Overall Survival (OS)
NCT01642251 (5) [back to overview]Neurotoxicity Total Score Change Between Baseline and 3 Months After Treatment Start
NCT01642251 (5) [back to overview]Overall Response Rate (ORR)
NCT01642251 (5) [back to overview]Progression Free Survival (Phase II)
NCT01642251 (5) [back to overview]Recommended Phase II Dose (Phase I)
NCT01670500 (5) [back to overview]Clinical Response Rate
NCT01670500 (5) [back to overview]Rate of Pathologic Complete Response (pCR)
NCT01670500 (5) [back to overview]Rate of Residual Cancer Burden (RCB) 0/1
NCT01670500 (5) [back to overview]Number of Grade 3 and Grade 4 Adverse Events
NCT01670500 (5) [back to overview]Rate of Miller Payne 4 and 5
NCT01675765 (2) [back to overview]Objective Tumor Response
NCT01675765 (2) [back to overview]Number of Subjects Reporting Adverse Events
NCT01679405 (5) [back to overview]Number of Adverse Events
NCT01679405 (5) [back to overview]Objective Response Rate
NCT01679405 (5) [back to overview]Overall Survival (OS)
NCT01679405 (5) [back to overview]Time to Progress (TTP)
NCT01679405 (5) [back to overview]Tumor Control Rate
NCT01687413 (13) [back to overview]Rate of Distant Metastasis
NCT01687413 (13) [back to overview]Locoregional Control
NCT01687413 (13) [back to overview]Disease Specific Survival
NCT01687413 (13) [back to overview]Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity
NCT01687413 (13) [back to overview]Change in Cognitive Function as Measured by Cognitive Failures Questionnaire
NCT01687413 (13) [back to overview]Change in Hearing as Measured by Hearing Handicap Inventory - Adult
NCT01687413 (13) [back to overview]Change in Quality of Life as Measured by EORTC QLQ-C30
NCT01687413 (13) [back to overview]Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)
NCT01687413 (13) [back to overview]Change in Quality of Life as Measured by Speech Handicap Index
NCT01687413 (13) [back to overview]Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory
NCT01687413 (13) [back to overview]Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire
NCT01687413 (13) [back to overview]Number of Complications/Acute Toxicity by Organ Class
NCT01687413 (13) [back to overview]Number of Participants With Disease-free Survival (DFS)
NCT01711541 (2) [back to overview]Toxicity (Phase I and Phase II)
NCT01711541 (2) [back to overview]Dose Limiting Toxicity (Phase I)
NCT01726582 (4) [back to overview]Number of Subjects Completing Therapy Including Surgical Resection.
NCT01726582 (4) [back to overview]Overall Survival in Months
NCT01726582 (4) [back to overview]Use of Biomarkers to Determine Course of Treatment
NCT01726582 (4) [back to overview]Progression-free Survival
NCT01732640 (2) [back to overview]Number of Participants With Dose Limiting Toxicities
NCT01732640 (2) [back to overview]Maximum Tolerated Dose (MTD) of Afatinib
NCT01798004 (1) [back to overview]The Tolerability of BuMel Regimen
NCT01822496 (6) [back to overview]Progression-free Survival
NCT01822496 (6) [back to overview]Percentage of Patients With Complete or Partial Response
NCT01822496 (6) [back to overview]Overall Survival
NCT01822496 (6) [back to overview]Number of Patients With Grade 3-5 Adverse Events
NCT01822496 (6) [back to overview]Local-regional Progression-free Survival
NCT01822496 (6) [back to overview]Distant Progression-free Survival
NCT01893801 (3) [back to overview]Overall Survival
NCT01893801 (3) [back to overview]Progression-Free Survival
NCT01893801 (3) [back to overview]Percentage Change in CA 19-9
NCT01898494 (5) [back to overview]Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
NCT01898494 (5) [back to overview]Progression-free Survival Rate at 2 Years
NCT01898494 (5) [back to overview]Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
NCT01898494 (5) [back to overview]Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score
NCT01898494 (5) [back to overview]Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins
NCT01907100 (4) [back to overview]Progression-Free Survival (PFS)
NCT01907100 (4) [back to overview]Overall Survival (OS)
NCT01907100 (4) [back to overview]Objective Response According to Modified RECIST- Investigator Assessment
NCT01907100 (4) [back to overview]Disease Control According to Modified RECIST- Investigator Assessment
NCT01918306 (5) [back to overview]Maximum Tolerated Dose(MTD) of GDC-0941 and Recommended Phase II Dose of GDC-0941 Given in Combination With Cisplatin. - (Phase Ib)
NCT01918306 (5) [back to overview]Number of Patients With Dose-limiting Toxicities Per NCI Common Terminology for Adverse Events (CTCAE) - (Phase Ib)
NCT01918306 (5) [back to overview]Percentage of Patients Achieving Overall Response - (Phase II)
NCT01918306 (5) [back to overview]Time to Progression - (Phase II)
NCT01918306 (5) [back to overview]Clinical Benefit Rate - (Phase II)
NCT01938573 (3) [back to overview]Percent of Patients With Pathologic Complete Response (Phase II)
NCT01938573 (3) [back to overview]Incidence of Adverse Events Including Any Unfavorable and Unintended Sign, Symptom, Diagnosis, or Disease Temporally Associated With the Use of a Medicinal Product, Whether or Not Related to the Medicinal Product (Phase I and II)
NCT01938573 (3) [back to overview]Patients With Dose Limiting Toxicity
NCT01982448 (2) [back to overview]Positive Predictive Value (PPV) of HRD Score
NCT01982448 (2) [back to overview]Number of Participants With Pathologic Response by HR-deficiency (HRD) Status
NCT01993329 (2) [back to overview]Provocative Concentration (PC20) After Methacholine Challenge
NCT01993329 (2) [back to overview]Highest FEV1 After Methacholine Challenge
NCT02000531 (2) [back to overview]Participants With Adverse Events
NCT02000531 (2) [back to overview]Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
NCT02052960 (6) [back to overview]Clinical Benefit Rate
NCT02052960 (6) [back to overview]Objective Response Rate (ORR)
NCT02052960 (6) [back to overview]Overall Survival
NCT02052960 (6) [back to overview]Progression-free Survival (PFS)
NCT02052960 (6) [back to overview]Time of Global Health Status Deterioration
NCT02052960 (6) [back to overview]Time to Treatment Failure
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Overall Survival Time
NCT02082522 (15) [back to overview]Change From Baseline on Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02083679 (2) [back to overview]Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
NCT02083679 (2) [back to overview]Number of Subjects With Dose Limiting Toxicities (DLTs)
NCT02092298 (2) [back to overview]Overall Survival (OS) From the First Laparoscopic HIPEC
NCT02092298 (2) [back to overview]Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy
NCT02127372 (4) [back to overview]Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
NCT02127372 (4) [back to overview]Phase II - Radiographic Response
NCT02127372 (4) [back to overview]Phase 2: 1 Year Survival
NCT02127372 (4) [back to overview]Phase 1 - Maximum Tolerated Dose (MTD) of STI571
NCT02128230 (1) [back to overview]The Remission Rate for Participants With High-risk Myeloma
NCT02196168 (7) [back to overview]Overall Survival
NCT02196168 (7) [back to overview]Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT02196168 (7) [back to overview]Levels of Pharmacodynamic Biomarkers
NCT02196168 (7) [back to overview]Levels of Predictive Biomarkers
NCT02196168 (7) [back to overview]Overall Response Rate (Complete Plus Partial Response) Using RECIST Criteria v1.1
NCT02196168 (7) [back to overview]Progression Free Survival
NCT02196168 (7) [back to overview]Progression Free Survival
NCT02254278 (7) [back to overview]Percentage of Participants With Grade 3+ Adverse Events
NCT02254278 (7) [back to overview]Percentage of Participants With Distant Metastasis
NCT02254278 (7) [back to overview]Percentage of Participants Alive
NCT02254278 (7) [back to overview]Percentage of Participants With Local-regional Failure
NCT02254278 (7) [back to overview]Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years
NCT02254278 (7) [back to overview]Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)
NCT02254278 (7) [back to overview]Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)
NCT02256982 (1) [back to overview]Number of Participants Post Operative/Radiation Therapy Complications
NCT02281955 (6) [back to overview]2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
NCT02281955 (6) [back to overview]2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
NCT02281955 (6) [back to overview]2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
NCT02281955 (6) [back to overview]2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
NCT02281955 (6) [back to overview]2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
NCT02281955 (6) [back to overview]2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
NCT02296684 (6) [back to overview]Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events
NCT02296684 (6) [back to overview]Number of Surgical Complications and/or Delays in Cohorts 1 and 2
NCT02296684 (6) [back to overview]Locoregional Recurrence Rates in Cohorts 1 and 2
NCT02296684 (6) [back to overview]Distant Failure Rate in Cohorts 1 and 2
NCT02296684 (6) [back to overview]Rate of Major Pathologic Treatment Effect in Cohort 1
NCT02296684 (6) [back to overview]Rate of Major Pathologic Treatment Effect in Cohort 2
NCT02300610 (4) [back to overview]Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)
NCT02300610 (4) [back to overview]Recommended Dose of Enzalutamide
NCT02300610 (4) [back to overview]Progression Free Survival (PFS)
NCT02300610 (4) [back to overview]Overall Survival (OS)
NCT02325401 (5) [back to overview]Overall Survival
NCT02325401 (5) [back to overview]Progression Free Survival
NCT02325401 (5) [back to overview]Number of Participants With Adverse Events
NCT02325401 (5) [back to overview]Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation
NCT02325401 (5) [back to overview]Number of Participants Experiencing No-Reoccurrence at 36 Months
NCT02358863 (1) [back to overview]The Number of Patients With Tumor Size Reduction (Objective Response Rate)
NCT02392637 (3) [back to overview]Number of Participants With Treatment Response Rate
NCT02392637 (3) [back to overview]Median Progression Free Survival (PFS)
NCT02392637 (3) [back to overview]Median Overall Survival (OS)
NCT02412670 (7) [back to overview]Proportion of Patients With Renal Insufficiency at Completion of Surgery
NCT02412670 (7) [back to overview]Proportion of Patients With Renal Insufficiency at Completion of Chemotherapy
NCT02412670 (7) [back to overview]Event-free Survival
NCT02412670 (7) [back to overview]Cumulative Incidence of Cancer-specific Death at 24 Months
NCT02412670 (7) [back to overview]Complete Pathologic Response Rate
NCT02412670 (7) [back to overview]Recurrence-free Survival
NCT02412670 (7) [back to overview]Bladder Cancer-free Survival
NCT02445391 (6) [back to overview]Health-related Quality of Life (HRQL) at 6-month Assessment
NCT02445391 (6) [back to overview]Proportion of Basal Subtype
NCT02445391 (6) [back to overview]Health-related Quality of Life (HRQL) at 15-month Assessment
NCT02445391 (6) [back to overview]3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients
NCT02445391 (6) [back to overview]3-year Overall Survival (OS) Rate in Basal-Subtype Patients
NCT02445391 (6) [back to overview]3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
NCT02453282 (29) [back to overview]Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab
NCT02453282 (29) [back to overview]Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]DoR; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]DoR; FAS Population
NCT02453282 (29) [back to overview]Ctrough_ss of Tremelimumab
NCT02453282 (29) [back to overview]Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
NCT02453282 (29) [back to overview]Serum Concentrations of Durvalumab
NCT02453282 (29) [back to overview]Serum Concentrations of Tremelimumab
NCT02453282 (29) [back to overview]Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy
NCT02453282 (29) [back to overview]PFS2; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]Percentage of Participants APF12; FAS Population
NCT02453282 (29) [back to overview]Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]Cmax_ss of Tremelimumab
NCT02453282 (29) [back to overview]Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy
NCT02453282 (29) [back to overview]Number of Participants With ADA Response to Tremelimumab
NCT02453282 (29) [back to overview]Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at 12 Months
NCT02453282 (29) [back to overview]Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab
NCT02453282 (29) [back to overview]Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]PFS2; FAS Population
NCT02453282 (29) [back to overview]OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
NCT02453282 (29) [back to overview]OS; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
NCT02453282 (29) [back to overview]PFS; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]OS; FAS Population
NCT02453282 (29) [back to overview]ORR; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]ORR; FAS Population
NCT02453282 (29) [back to overview]PFS; FAS Population
NCT02542293 (20) [back to overview]DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02542293 (20) [back to overview]APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02542293 (20) [back to overview]Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Serum Concentrations of Durvalumab
NCT02542293 (20) [back to overview]OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets
NCT02542293 (20) [back to overview]OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set
NCT02542293 (20) [back to overview]Serum Concentrations of Tremelimumab
NCT02542293 (20) [back to overview]Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02542293 (20) [back to overview]PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets
NCT02542293 (20) [back to overview]OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02542293 (20) [back to overview]ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets
NCT02542293 (20) [back to overview]Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
NCT02542293 (20) [back to overview]Number of Participants With ADA Response to Tremelimumab
NCT02542293 (20) [back to overview]Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set
NCT02567409 (4) [back to overview]Treatment Limiting Adverse Events
NCT02567409 (4) [back to overview]Progression-free Survival (PFS)
NCT02567409 (4) [back to overview]Overall Survival (OS)
NCT02567409 (4) [back to overview]Confirmed Objective Response Rate
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
NCT02573493 (19) [back to overview]Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1
NCT02573493 (19) [back to overview]Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4
NCT02573493 (19) [back to overview]Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
NCT02573493 (19) [back to overview]Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events
NCT02573493 (19) [back to overview]Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
NCT02573493 (19) [back to overview]Arm 3: Median Percent Weight Loss
NCT02573493 (19) [back to overview]Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
NCT02573493 (19) [back to overview]Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
NCT02586207 (2) [back to overview]Evaluation of the Efficacy of Pembrolizumab Given in Combination With Definitive CRT by Determining the Number of Participants With Complete Response at Treatment End (Day 150)
NCT02586207 (2) [back to overview]Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.
NCT02659059 (17) [back to overview]Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2
NCT02659059 (17) [back to overview]Progression Free Survival (PFS) - Part 1
NCT02659059 (17) [back to overview]Overall Survival (OS) - Part 2
NCT02659059 (17) [back to overview]Overall Survival (OS) - Part 1
NCT02659059 (17) [back to overview]Objective Response Rate (ORR) - Part 1
NCT02659059 (17) [back to overview]Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2
NCT02659059 (17) [back to overview]Objective Response Rate (ORR) - Part 2
NCT02659059 (17) [back to overview]Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1
NCT02659059 (17) [back to overview]Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2
NCT02659059 (17) [back to overview]Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1
NCT02659059 (17) [back to overview]Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1
NCT02659059 (17) [back to overview]Overall Survival (OS) by PD-L1 Expression Levels - Part 1
NCT02659059 (17) [back to overview]Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1
NCT02659059 (17) [back to overview]Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1
NCT02659059 (17) [back to overview]Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1
NCT02659059 (17) [back to overview]Number of Participants With Adverse Events (AEs) - Part 2
NCT02659059 (17) [back to overview]Progression Free Survival (PFS) - Part 2
NCT02709512 (4) [back to overview]Response Rate
NCT02709512 (4) [back to overview]Progression Free Survival
NCT02709512 (4) [back to overview]Overall Survival
NCT02709512 (4) [back to overview]Overall Survival Phase 3 Interim Analysis
NCT02741570 (8) [back to overview]Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 - Extended Collection
NCT02741570 (8) [back to overview]Objective Response Rate (ORR)
NCT02741570 (8) [back to overview]Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1
NCT02741570 (8) [back to overview]Duration of Objective Response (DOR)
NCT02741570 (8) [back to overview]Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20
NCT02741570 (8) [back to overview]Progression Free Survival (PFS)
NCT02741570 (8) [back to overview]Overall Survival (OS) in All Randomized Participants - Extended Collection
NCT02741570 (8) [back to overview]Overall Survival (OS) in All Randomized Participants
NCT02855944 (12) [back to overview]Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)
NCT02855944 (12) [back to overview]Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)
NCT02855944 (12) [back to overview]Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)
NCT02855944 (12) [back to overview]Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)
NCT02855944 (12) [back to overview]Overall Survival (ITT Population)
NCT02855944 (12) [back to overview]Overall Survival (Efficacy Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (Efficacy Population)
NCT02862457 (17) [back to overview]Maximum Concentration (Cmax) of Pembrolizumab in Part A Cycle 1
NCT02862457 (17) [back to overview]Number of Participants Who Discontinued Study Treatment Due to An Adverse Event (AE)
NCT02862457 (17) [back to overview]Trough Concentration (Ctrough) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Time to Maximum Concentration (Tmax) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Time to Maximum Concentration (Tmax) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Terminal Half-Life (t1/2) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Terminal Half-Life (t1/2) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Maximum Concentration (Cmax) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
NCT02862457 (17) [back to overview]Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Maximum Concentration (Cmax) of Pembrolizumab in Part B Cycle 1
NCT02862457 (17) [back to overview]Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Number of Participants Who Experienced At Least One Adverse Event (AE)
NCT02862457 (17) [back to overview]Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
NCT02862457 (17) [back to overview]Trough Concentration (Ctrough) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Maximum Concentration (Cmax) of Epacadostat in Part A
NCT02862457 (17) [back to overview]Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
NCT02937116 (13) [back to overview]Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)
NCT02937116 (13) [back to overview]Number of All Study Participants Who Demonstrate a Tumor Response
NCT02937116 (13) [back to overview]DOR According to RECIST 1.1 as Assessed by Investigator
NCT02937116 (13) [back to overview]Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
NCT02937116 (13) [back to overview]Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator
NCT02937116 (13) [back to overview]OS for Participants
NCT02937116 (13) [back to overview]PFS According to RECIST 1.1 as Assessed by Investigator
NCT02937116 (13) [back to overview]Clearance of IBI308 in Plasma After Single Dose Administration
NCT02937116 (13) [back to overview]The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration
NCT02937116 (13) [back to overview]Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants
NCT02937116 (13) [back to overview]Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants
NCT02937116 (13) [back to overview]TTR According to RECIST 1.1 as Assessed by Investigator
NCT02937116 (13) [back to overview]Volume of Distribution of IBI308 in Plasma After Single Dose Administration
NCT02983045 (3) [back to overview]Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
NCT02983045 (3) [back to overview]Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)
NCT02983045 (3) [back to overview]Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
NCT02990468 (6) [back to overview]Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production
NCT02990468 (6) [back to overview]Incidence of Radiation-induced Xerostomia by Clinician Scoring
NCT02990468 (6) [back to overview]Duration of Radiation-induced Mucositis
NCT02990468 (6) [back to overview]Incidence of Radiation-induced Xerostomia by Stimulated Saliva Production
NCT02990468 (6) [back to overview]Assess the Safety of the Study Drug by Calculating the Proportion of Patients Who Experience Grade 4 or 5 Study Drug Related Adverse Events, as Assessed by CTCAE v 4.03.
NCT02990468 (6) [back to overview]Incidence Radiation-induced Mucositis by Clinician Scoring
NCT03003962 (44) [back to overview]PFS2 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]PFS Based on Investigator Assessment According to RECIST 1.1 in LREM Analysis Set
NCT03003962 (44) [back to overview]Overall Survival (OS)
NCT03003962 (44) [back to overview]OS in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]OS in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]OS in Participants With LREM
NCT03003962 (44) [back to overview]OS at 24 Months in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 24 Months in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]OS at 24 Months in PD-L1 TC > = 25% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 24 Months
NCT03003962 (44) [back to overview]OS at 18 Months in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 18 Months in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]OS at 18 Months in PD-L1 TC > = 25% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 18 Months
NCT03003962 (44) [back to overview]ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment
NCT03003962 (44) [back to overview]Duration of Response (DoR) as Per RECIST 1.1 Using Investigator Assessment
NCT03003962 (44) [back to overview]DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% LREM Analysis Set
NCT03003962 (44) [back to overview]DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% Analysis Set
NCT03003962 (44) [back to overview]DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=25% LREM Analysis Set
NCT03003962 (44) [back to overview]APF12 in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]APF12 in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]APF12 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Alive and Progression-Free at 12 Months (APF12)
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-LC13
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-C30
NCT03003962 (44) [back to overview]Percentage of Participants With Antidrug Antibody (ADA) Response to Durvalumab
NCT03003962 (44) [back to overview]Percentage of Participants With ADA Response to Durvalumab in LREM Analysis Set
NCT03003962 (44) [back to overview]Number of Participants With ECOG Performance Status in PD-L1 TC >=25% LREM Analysis Set
NCT03003962 (44) [back to overview]Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
NCT03003962 (44) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire Version 3 (QLQ-C30)
NCT03003962 (44) [back to overview]Change From Baseline in EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Change From Baseline in EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Change From Baseline in EORTC 13-Item Lung Cancer Quality of Life Questionnaire (QLQ-LC13)
NCT03003962 (44) [back to overview]Time From Randomization to Second Progression (PFS2)
NCT03003962 (44) [back to overview]Progression Free Survival (PFS) Based on Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
NCT03003962 (44) [back to overview]PFS2 in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]PFS2 in PD-L1 TC >= 50% Analysis Set
NCT03040999 (7) [back to overview]Change From Baseline in Global Health Status/Quality of Life (GHS/QoL)
NCT03040999 (7) [back to overview]Change From Baseline in Physical Functioning
NCT03040999 (7) [back to overview]Event-free Survival (EFS)
NCT03040999 (7) [back to overview]Number of Participants Discontinuing Study Drug Due to an AE
NCT03040999 (7) [back to overview]Change From Baseline in Swallowing, Speech, and Pain Symptoms
NCT03040999 (7) [back to overview]Overall Survival (OS)
NCT03040999 (7) [back to overview]Number of Participants With Adverse Events (AEs)
NCT03067610 (7) [back to overview]Number of Patients With Solitary Elective Volume Recurrence
NCT03067610 (7) [back to overview]Overall Survival
NCT03067610 (7) [back to overview]Progression-free Survival
NCT03067610 (7) [back to overview]Total Number of Participants With Gastrostomy Dependence
NCT03067610 (7) [back to overview]Probability of Locoregional or Distant Tumor Failure
NCT03067610 (7) [back to overview]Quality of Life (QOL) Patient Reported Outcomes (PRO)
NCT03067610 (7) [back to overview]Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
NCT03164616 (13) [back to overview]Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
NCT03164616 (13) [back to overview]PK of Tremelimumab; Peak and Trough Serum Concentrations
NCT03164616 (13) [back to overview]Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13)
NCT03164616 (13) [back to overview]Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations
NCT03164616 (13) [back to overview]Duration of Response (DoR)
NCT03164616 (13) [back to overview]Number of Patients With ADA Response to Tremelimumab
NCT03164616 (13) [back to overview]Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
NCT03164616 (13) [back to overview]Time From Randomization to Second Progression (PFS2)
NCT03164616 (13) [back to overview]Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
NCT03164616 (13) [back to overview]PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC
NCT03164616 (13) [back to overview]Overall Survival (OS); D + SoC Compared With SoC Alone
NCT03164616 (13) [back to overview]OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC
NCT03164616 (13) [back to overview]Objective Response Rate (ORR)
NCT03317496 (13) [back to overview]Number of Participants With Treatment Related TEAEs
NCT03317496 (13) [back to overview]Overall Survival (OS)
NCT03317496 (13) [back to overview]Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT)
NCT03317496 (13) [back to overview]Progression Free Survival (PFS) as Per RECIST v 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Time-to-Tumor Response (TTR) as Per RECIST v 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Number of Participants With Grade 3 or Higher Laboratory Abnormalities by CTCAE Grade
NCT03317496 (13) [back to overview]Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression
NCT03317496 (13) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
NCT03317496 (13) [back to overview]Serum Concentration of Avelumab
NCT03317496 (13) [back to overview]Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue
NCT03317496 (13) [back to overview]Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03
NCT03345784 (3) [back to overview]Progression-free Survival
NCT03345784 (3) [back to overview]Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities
NCT03345784 (3) [back to overview]Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin
NCT03382561 (3) [back to overview]Response Rate
NCT03382561 (3) [back to overview]Overall Survival (OS)
NCT03382561 (3) [back to overview]Progression-free Survival (PFS)
NCT03389477 (1) [back to overview]Tumor Response Rate of Newly Diagnosed p16INK4a Negative, HPV-unrelated HNSCC to Neoadjuvant Palbociclib Monotherapy
NCT03502148 (7) [back to overview]Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities
NCT03502148 (7) [back to overview]Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses
NCT03502148 (7) [back to overview]Number of Loco-regional Recurrences
NCT03502148 (7) [back to overview]Systemic Platinum Levels (Cmax)
NCT03502148 (7) [back to overview]Technical Success - Residual Cisplatin Levels Post-application
NCT03502148 (7) [back to overview]Tumor Response (Tumor Volume Change From Baseline and Pre-op Visit, Approximately 21 Days Prior to Surgical Excision of the Tumor)
NCT03502148 (7) [back to overview]Tumor and Lymph Node (if Available) Platinum Levels
NCT03541252 (4) [back to overview]Imaging-based Tumor Response: Complete Tumor Clearance Determined by Physician Performing Imaging
NCT03541252 (4) [back to overview]Tumor Response- Clinical Clearance Determined by Clinical Assessment by Physician
NCT03541252 (4) [back to overview]Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE
NCT03541252 (4) [back to overview]Tumor Response- Histological Tumor Clearance Determined by Pathologist
NCT03617913 (2) [back to overview]Progression-free Survival
NCT03617913 (2) [back to overview]Proportion of Participants With Complete Response (At 6 Months)
NCT03621696 (4) [back to overview]Percentage of Participants Taking Narcotics
NCT03621696 (4) [back to overview]Mean Percent Weight Change
NCT03621696 (4) [back to overview]Disease Recurrence Rate
NCT03621696 (4) [back to overview]Change in Serum Creatinine
NCT03690921 (6) [back to overview]Acute Toxicity
NCT03690921 (6) [back to overview]Complete Response at 12 Weeks
NCT03690921 (6) [back to overview]Overall Survival at 24 Months
NCT03690921 (6) [back to overview]Distant Metastasis-free Survival at 24 Months.
NCT03690921 (6) [back to overview]Complete Response at 24 Weeks
NCT03690921 (6) [back to overview]Local Progression Free Survival at 24 Months
NCT03737994 (12) [back to overview]Overall Survival (OS)
NCT03737994 (12) [back to overview]Overall Survival (OS)
NCT03737994 (12) [back to overview]Overall Survival (OS)
NCT03737994 (12) [back to overview]Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria
NCT03737994 (12) [back to overview]Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria
NCT03737994 (12) [back to overview]Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria
NCT03737994 (12) [back to overview]Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1
NCT03737994 (12) [back to overview]Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria
NCT03737994 (12) [back to overview]Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1
NCT03737994 (12) [back to overview]Number of Participants by Highest Grade Adverse Event Reported
NCT03737994 (12) [back to overview]Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria
NCT03737994 (12) [back to overview]Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria
NCT03738228 (8) [back to overview]Disease-free Survival (DFS) at 2 Years
NCT03738228 (8) [back to overview]Post-treatment 3-month PET/CT Metabolic Response
NCT03738228 (8) [back to overview]Immune Response
NCT03738228 (8) [back to overview]Percentage of Participants With Dose Limiting Toxicities
NCT03738228 (8) [back to overview]Pre-treatment PD-L1 Expression
NCT03738228 (8) [back to overview]T Cell Receptor (TCR) Diversity
NCT03738228 (8) [back to overview]T Cell Receptor (TCR) Simpson Clonality
NCT03738228 (8) [back to overview]Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5
NCT03775486 (11) [back to overview]Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
NCT03775486 (11) [back to overview]Number of Participants With Treatment-Related Adverse Events
NCT03775486 (11) [back to overview]Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
NCT03775486 (11) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
NCT03775486 (11) [back to overview]Concentration of Durvalumab
NCT03775486 (11) [back to overview]Duration of Response
NCT03775486 (11) [back to overview]Overall Survival
NCT03775486 (11) [back to overview]Presence of Anti-drug Antibodies (ADAs) for Durvalumab
NCT03775486 (11) [back to overview]Progression-free Survival
NCT03775486 (11) [back to overview]Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population
NCT03775486 (11) [back to overview]Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
NCT03786783 (5) [back to overview]Response Rate
NCT03786783 (5) [back to overview]Event-free Survival
NCT03786783 (5) [back to overview]"Percentage of Participants Who Are Feasibility Failure"
NCT03786783 (5) [back to overview]Percentage of Participants With Unacceptable Toxicity
NCT03786783 (5) [back to overview]Overall Survival
NCT03790111 (32) [back to overview]Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate (ORR), Local Reader's Assessment
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate, Local Read
NCT03790111 (32) [back to overview]Median Progression Free Survival
NCT03790111 (32) [back to overview]Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate, Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
NCT03790111 (32) [back to overview]Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
NCT03790111 (32) [back to overview]Disease Control Rate End of Study, Local Reviewer
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Local Reviewer
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Local Reviewer
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Change From Baseline in Serum Albumin
NCT03790111 (32) [back to overview]Change From Baseline in Serum Albumin
NCT03790111 (32) [back to overview]Change From Baseline in Serum Albumin
NCT03790111 (32) [back to overview]Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)
NCT03790111 (32) [back to overview]Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
NCT03790111 (32) [back to overview]Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
NCT03790111 (32) [back to overview]Progression Free Survival, Local Radiologist's Assessment
NCT03790111 (32) [back to overview]Project Overall Survival Rate at Month 12
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Project Overall Survival Rate at Month 6
NCT03790111 (32) [back to overview]Summary of Duration of Progression Free Survival, Local Radiologist's Assessment
NCT03790111 (32) [back to overview]Weight Change From Baseline
NCT03790111 (32) [back to overview]Weight Change From Baseline
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate, Local Reader's Assessment
NCT03790111 (32) [back to overview]Overall Survival (OS)
NCT03790111 (32) [back to overview]Progression Free Survival, Local Radiologist's Assessment
NCT03790111 (32) [back to overview]Weight Change From Baseline
NCT04003636 (6) [back to overview]Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)
NCT04003636 (6) [back to overview]Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
NCT04003636 (6) [back to overview]Number of Participants Who Experience One or More Adverse Events (AE)
NCT04003636 (6) [back to overview]Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT04003636 (6) [back to overview]Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
NCT04003636 (6) [back to overview]Overall Survival (OS)
NCT04012619 (1) [back to overview]the Maximum Tolerated Dose (MTD)
NCT04372927 (4) [back to overview]Frequency and Severity of Pneumonitis
NCT04372927 (4) [back to overview]Frequency of Adverse Events
NCT04372927 (4) [back to overview]Overall Survival (OS)
NCT04372927 (4) [back to overview]Response Rate
NCT04924062 (6) [back to overview]Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
NCT04924062 (6) [back to overview]Overall Survival (OS)
NCT04924062 (6) [back to overview]Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT04924062 (6) [back to overview]Number of Participants Who Experience One or More Adverse Events (AE)
NCT04924062 (6) [back to overview]Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
NCT04924062 (6) [back to overview]Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

Best Confirmed Response to Neoadjuvant Therapy

Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable. (NCT00003298)
Timeframe: Assessed at surgery time (surgery performed during week 8-10 after registration to the study)

Interventionpercentage of participants (Number)
Experimental Arm0

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Progression Free Survival

Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation. (NCT00003298)
Timeframe: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10

Interventionyears (Median)
Experimental Arm0.68

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Grade 3 or Higher Toxicity Incidence on Step 1

Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients. (NCT00003298)
Timeframe: assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)

Interventionpercentage of participants (Number)
Experimental Arm65.8

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Overall Survival

Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive. (NCT00003298)
Timeframe: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10

Interventionyears (Median)
Experimental Arm1.55

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Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment

(NCT00003377)
Timeframe: up to 21 weeks

,,,,
Interventionparticipants (Number)
Dose Limiting Toxicity(DLT)/Significant Dose DelayComplications unrelated to treatment
Arm 1, P I00
Arm 2, P I00
Arm 2, PII01
Arm 3, P I20
Arm 4, P I20

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Overall Survival at 2 Years

Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97) (NCT00003377)
Timeframe: 2 years

Interventionprobability (Mean)
Arm 2, P I & II0.80

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Disease-free Survival at 2 Years

"Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86).~Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study." (NCT00003377)
Timeframe: 2 years

Interventionprobability (Mean)
Arm 2, P I & II0.65

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Time to Progression

Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions (NCT00003907)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 year.

InterventionMonths (Median)
Hepatocellular Carcinoma2.3
Neuroendocrine Hepatic Metastases7.2

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Overall Survival

Overall survival was defined as time from registration to death from any causes. (NCT00003907)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 year.

InterventionMonths (Median)
Hepatocellular Carcinoma12.0
Neuroendocrine Hepatic Metastases21.2

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Tumor Response

Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response. (NCT00003907)
Timeframe: Assessed every 6 weeks

InterventionProportion of participants (Number)
Hepatocellular Carcinoma0
Neuroendocrine Hepatic Metastases0.17

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Number of Participants With Adverse Events

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00004547)
Timeframe: only assessed during the perioperative period (i.e. up to 90 days following surgery)

InterventionParticipants (Number)
Mesothelioma, Low Grade, and Adenocarcinoma73

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Number of Participants With a Response

Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity. (NCT00004547)
Timeframe: Patients were assessed every three months for one year and then every 6 months

InterventionParticipants (Number)
Peritoneal Mesothelioma24
Low Grade Mucinous Adenocarcinoma18
Adenocarcinoma of Gastrointestinal Origin6

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Disease Response Assessed by Modified RECIST Criteria

Number of participants with complete response and very good partial response at the end of protocol therapy. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)5
Arm II (RER With CR [ABVE-PC, IFRT])370
Arm III (RER With CR [ABVE-PC])380
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])538
Arm V (RER With PD)29
Arm VI (SER [DECA, ABVE-PC, IFRT])105
Arm VII (SER [ABVE-PC, IFRT])100

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Grade 3 or 4 Non-hematologic Toxicity

Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)10
Arm II (RER With CR [ABVE-PC, IFRT])153
Arm III (RER With CR [ABVE-PC])130
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])216
Arm V (RER With PD)11
Arm VI (SER [DECA, ABVE-PC, IFRT])62
Arm VII (SER [ABVE-PC, IFRT])45

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Event-free Survival

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.89
Arm II (RER With CR [ABVE-PC, IFRT])0.87
Arm III (RER With CR [ABVE-PC])0.84
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.87
Arm V (RER With PD)0.70
Arm VI (SER [DECA, ABVE-PC, IFRT])0.79
Arm VII (SER [ABVE-PC, IFRT])0.74

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Overall Survival

Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.93
Arm II (RER With CR [ABVE-PC, IFRT])0.98
Arm III (RER With CR [ABVE-PC])0.98
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.98
Arm VI (SER [DECA, ABVE-PC, IFRT])0.96
Arm VII (SER [ABVE-PC, IFRT])0.93

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Overall Survival Time

Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients. (NCT00033657)
Timeframe: Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

InterventionMonths (Median)
Cisplatin / Irinotecan / RT (Arm A)35.0
Paclitaxel / Cisplatin / RT (Arm B)21.0

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Pathologic Complete Response Rate

A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue. (NCT00033657)
Timeframe: approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

Interventionpercentage of participants (Number)
Cisplatin / Irinotecan / RT (Arm A)15.4
Paclitaxel / Cisplatin / RT (Arm B)16.7

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Recurrence-free Survival Time

Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients. (NCT00033657)
Timeframe: Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

InterventionMonths (Median)
Cisplatin / Irinotecan / RT (Arm A)39.8
Paclitaxel / Cisplatin / RT (Arm B)12.4

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Disease-free Survival (Percentage of Participants Alive Without Disease)

Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. (NCT00047008)
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.

Interventionpercentage of participants (Number)
Standard Fractionation RT + Cisplatin51.4
Accelerated Fractionation RT + Cisplatin53.4

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Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year

The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC). (NCT00047008)
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.

Interventionscore on a scale * months (Mean)
Standard Fractionation RT + Cisplatin5.27
Accelerated Fractionation RT + Cisplatin5.19

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Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]

Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. (NCT00047008)
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.

Interventionpercentage of participants (Number)
Standard Fractionation RT + Cisplatin25.6
Accelerated Fractionation RT + Cisplatin28.2

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Local-regional Failure (Percentage of Participants With Local-regional Failure)

Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. (NCT00047008)
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.

Interventionpercentage of participants (Number)
Standard Fractionation RT + Cisplatin25.5
Accelerated Fractionation RT + Cisplatin28.7

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Overall Survival (Percentage of Participants Alive)

Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. (NCT00047008)
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.

Interventionpercentage of patients (Number)
Standard Fractionation RT + Cisplatin64.3
Accelerated Fractionation RT + Cisplatin70.3

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Percentage of Participants With Toxicity Grade 3 or Higher

Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data. (NCT00047008)
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.

,
Interventionpercentage of participants (Number)
AcuteLate
Accelerated Fractionation RT + Cisplatin80.025.7
Standard Fractionation RT + Cisplatin83.721.1

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PSS-HN Understandability of Speech Score - AUC at One Year

The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating, and Understandability of Speech (this outcome measure). Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC). (NCT00047008)
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.

Interventionscore on a scale * months (Mean)
Standard Fractionation RT + Cisplatin90.48
Accelerated Fractionation RT + Cisplatin91.77

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PSS-HN Public Eating Score - AUC at One Year

The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating (this outcome measure), and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC). (NCT00047008)
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.

Interventionscore on a scale * months (Mean)
Standard Fractionation RT + Cisplatin65.81
Accelerated Fractionation RT + Cisplatin67.10

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Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]

Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. (NCT00047008)
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.

Interventionpercentage of participants (Number)
Standard Fractionation RT + Cisplatin55.8
Accelerated Fractionation RT + Cisplatin57.0

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Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year

The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC). (NCT00047008)
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.

Interventionscore on a scale * months (Mean)
Standard Fractionation RT + Cisplatin53.36
Accelerated Fractionation RT + Cisplatin53.63

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Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)

"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR" (NCT00057837)
Timeframe: Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

Interventionproportion of participants (Number)
PET (Topotecan/Etoposide/Cisplatin/G-CSF)0.697
PIE (Irinotecan/Cisplatin/Etoposide)0.576

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Duration of Response

Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started. (NCT00057837)
Timeframe: Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

InterventionMonths (Median)
PET (Topotecan/Etoposide/Cisplatin/G-CSF)6.0
PIE (Irinotecan/Cisplatin/Etoposide)6.0

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Overall Survival

Overall survival is defined as the time from randomization to death. (NCT00057837)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 years

InterventionMonths (Median)
PET (Topotecan/Etoposide/Cisplatin/G-CSF)11.9
PIE (Irinotecan/Cisplatin/Etoposide)11.0

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Disease Free Survival (DFS)

Overall Survival (OS) and Disease Free Survival (DFS) are the secondary endpoints. Technical problems with measurement of OS leading to unreliable or uniterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only DFS data is being reported. (NCT00062374)
Timeframe: Every 3 mos for the first 2 yrs, then every 6 mos for 2 years and once a year afterwards, up to 5 years

Interventionmonths (Median)
Arm I23.8

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Histological Response Determined by FDG Uptake Correlates

"The primary objective was to demonstrate that a decrease in FDG-SUV discriminates treatment response. Response was defined pathologically based on microscopic inspection for residual cancer cells and fibrosis.~Using a two sample t-test, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders. Data adjudication was invalid, and needs to be re-adjudicated~Non-Responder= Tumor Regression Grade 3 or higher Responder=Tumor Regression Grade 1 (CR) or Grade 2 (PR)" (NCT00062374)
Timeframe: Day 15

Interventionparticipants (Number)
Progression of DiseaseRespondersNon-Responders
Arm I2338

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Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection

Maximum grade of physician assessed neurotoxicity and infection (NCT00063999)
Timeframe: Assessed throughout the treatment period and for 30 days after discontinuation of treatment.

,
InterventionParticipants (Count of Participants)
Grade < 2 Sensory neuropathyGrade 2 or Higher Sensory NeuropathyGrade <3 infection with NeutropeGrade 3 or Higher Infection with NeutropeniaGrade <3 infection without NeutropeniaGrade 3 or Higher Infection without Neutropenia
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)1674732561522618
Arm II (Paclitaxel, Carboplatin)1305342963513651

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Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G

The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL. (NCT00063999)
Timeframe: Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment

,
Interventionunits on a scale (Least Squares Mean)
Baseline6 weeks15 weeks26 weeks
Arm I (Doxorubicin, Cisplatin, Paclitaxel)39.435.535.339.8
Arm II (Paclitaxel, Carboplatin)37.937.536.538.5

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Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)

The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life). (NCT00063999)
Timeframe: Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start

,
Interventionunits on a scale (Least Squares Mean)
Baseline6 Weeks15 Weeks26 Weeks
Doxorubicin, Cisplatin, Paclitaxel14.913.511.19.5
Paclitaxel, Carboplatin14.911.311.210.9

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Pain, Assessed by Brief Pain Inventory

"Single item from the Brief Pain Inventory (BPI) assessing worst pain in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score." (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)4.03.53.62.3
Arm II (Vinorelbine, Cisplatin)3.93.54.03.2
Arm III (Gemcitabine, Cisplatin)3.33.43.53.7
Arm IV (Topotecan, Cisplatin)3.63.62.52.9

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Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).

The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)14.414.113.111.1
Arm II (Vinorelbine, Cisplatin)13.513.313.111.4
Arm III (Gemcitabine, Cisplatin)14.213.714.112.3
Arm IV (Topotecan, Cisplatin)14.114.214.413.1

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Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)

The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL. (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)66.665.270.571.9
Arm II (Vinorelbine, Cisplatin)69.165.566.669.9
Arm III (Gemcitabine, Cisplatin)67.965.364.568.6
Arm IV (Topotecan, Cisplatin)68.166.268.470.9

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Duration of Overall Survival (OS)

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. (NCT00064077)
Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Interventionmonths (Median)
Arm I (Paclitaxel, Cisplatin)12.87
Arm II (Vinorelbine, Cisplatin)9.99
Arm III (Gemcitabine, Cisplatin)10.28
Arm IV (Topotecan, Cisplatin)10.25

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Duration of Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. (NCT00064077)
Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Interventionmonths (Median)
Arm I (Paclitaxel, Cisplatin)5.82
Arm II (Vinorelbine, Cisplatin)3.98
Arm III (Gemcitabine, Cisplatin)4.70
Arm IV (Topotecan, Cisplatin)4.57

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Complete Clinical and Pathologic Response

Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen. (NCT00068406)
Timeframe: Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.

InterventionPercentage of Participants (Number)
Cisplatin + Radiation, Then Surgery50

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Median Overall Survival (OS)

Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death. (NCT00068575)
Timeframe: Participants followed till disease progression or death (approximately 6 years)

Interventionmonths (Median)
Postoperative Chemoradiation Regimen42

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Overall Survival

Will be estimated using the method of Kaplan-Meier. (NCT00083122)
Timeframe: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years

Interventionmonths (Median)
Group 1 (Platin Resistant)17.5

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Time to Progression

Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00083122)
Timeframe: Time from registration to the date of progression or last follow-up, assessed up to 3 years

Interventionmonths (Median)
Group 1 (Platin Resistant)4.3

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Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)

"A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers.~A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.~A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart." (NCT00083122)
Timeframe: 24 weeks

,
InterventionPercentage of Participants (Number)
Complete Response (CR)Partial Response (PR)
Group 1 (Platin Resistant)2.515
Group 2 (Platin Sensitive)040

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Overall Survival

Overall Survival at six years after initiating protocol therapy (NCT00083551)
Timeframe: 6 Years

Interventionpercentage of participants (Number)
Thalidomide65
No Thalidomide58

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Pre-Radiation Therapy Chemotherapeutic Response

"Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR.~Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): >/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): <50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): >/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples." (NCT00084838)
Timeframe: Assessed at study entry and pre-RT/post-CT at week 7.

Interventionproportion of evaluable patients (Number)
Multi-agent Intrathecal and Systemic CT With RT (Modified IRS0.58

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Grade 3-4 Hepatic Events

All Grade 3-4 Hepatic events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)8

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Grade 3-4 Hemorrhage Events

All Grade 3-4 Hemorrhage events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)1

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Grade 3-4 Dermatology Events

All Grade 3-4 Dermatology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)3

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Grade 3-4 Gastrointestinal Events

All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)139

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Grade 3-4 Constitutional Events

All Grade 3-4 Constitutional events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)22

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Grade 3-4 Cardiovascular Events

All Grade 3-4 Cardiovascular events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)6

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Grade 3-4 Blood/Bone Marrow Events

"All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms.~Arm Name" (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)564

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Grade 3-4 Auditory/Hearing Events

All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)8

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Grade 3-4 Allergy/Immunology

All Grade 3-4 Allergy/Immunology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)1

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2-yr Overall Survival

Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up. (NCT00084838)
Timeframe: Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.

Interventionprobability (Number)
Multi-agent Intrathecal and Systemic CT With RT (Modified IRS0.70

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Grade 3/4 Events

All Grade 3-4 events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)1021

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Grade 3-4 Renal/Genitourinary Events

All Grade 3-4 Renal/Genitourinary events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)4

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Grade 3-4 Pulmonary Events

All Grade 3-4 Pulmonary events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)4

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Grade 3-4 Pain Events

All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)31

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Grade 3-4 Neurology Events

All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)45

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Grade 3-4 Muscloskeletal Events

All Grade 3-4 Muscloskeletal events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)8

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Grade 3-4 Metabolic/Laboratory Events

All Grade 3-4 Metabolic/Laboratory events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)128

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Grade 3-4 Infection/Febrile Neutropenia Events

All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

Interventionadverse events (Number)
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)49

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Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. The list of toxicities of interest include Anemia or Febrile Neutropenia; Nausea or Vomiting; Infections and Infestations; Neutrophil or White blood count decrease; and Hypokalemia or Hyponatremia (NCT00085098)
Timeframe: From the beginning of treatment, assessed up to 5 years

InterventionParticipants (Count of Participants)
Anemia or Febrile NeutropeniaNausea or VomitingInfections and InfestationsNeutorphil or White blood count decreaseHypokalemia or Hyponatremia
Regimen B (Chemotherapy Plus Radiotherapy)22273

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Quality of Life (QOL) and Neurocognitive Assessment (NP)

The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. The scores range from 0 to 100 with higher score reflecting better QoL or neurocognitive assessment. (NCT00085098)
Timeframe: 2 years from beginning of treatment

,
InterventionScores on a scale (Mean)
Overall IQ ScoreSelf Report Score-Internalizing ProblemsSelf Report Score-Emotional ProblemsSelf Report Score-Personal Adjustment StrengthsParent Report QoL Total ScoreSelf Report QoL Total Score
Regimen A (Radiotherapy Only)98.6041.0044.0051.5088.0495.65
Regimen B (Chemotherapy Plus Radiotherapy)92.4342.5042.0060.5079.3590.76

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Event-free Survival

"Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up.~QEs: 1)disease progression, defined as increase >= 40% in tumor volume or >= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause.~Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol's primary objective.~NOTE: Reported data are through May 2009 (see Caveats section)." (NCT00085098)
Timeframe: Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years

,
Interventionparticipants (Number)
Experienced a qualifying eventEvent-free through 3 years of follow-upEvent-free at data cutoff (if < 3 years follow-up)Withdrew from study prior to 3 years of follow-upLost to follow-up prior to 3 years of follow-up
Regimen A (Radiotherapy Only)10900
Regimen B (Chemotherapy Plus Radiotherapy)101100

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Number of Participants With a Response to Regimen B

To assess the complete response rate to pre-radiotherapy chemotherapy (Reg B only). Response was determined after completing 2-4 cycles of chemotherapy on Reg B. Complete Response (CR) is defined as disappearance of all target lesions. (NCT00085098)
Timeframe: 5 years from beginning of treatment

InterventionParticipants (Count of Participants)
Regimen B (Chemotherapy Plus Radiotherapy)8

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Event-free Survival (EFS)

EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's). (NCT00085735)
Timeframe: Assessed at 3 years

,
Interventionprobability of 3 year EFS (Number)
IFRT vs PFRT
Involved Field Radiation (IFRT)85.8
Posterior Fossa Radiation (PFRT)85.8

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Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)

Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. (NCT00085735)
Timeframe: 49 - 72 months post diagnosis

InterventionScores on a scale (Mean)
Low-dose Craniospinal Radiation (LDSCI)90.5
Standard-dose Craniospinal Radiation (SDCSI)86.4

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Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)

Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better. (NCT00085735)
Timeframe: 27 - 48 months post diagnosis

InterventionScores on a scale (Mean)
Low-dose Craniospinal Radiation (LDSCI)92.2
Standard-dose Craniospinal Radiation (SDCSI)90.5

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Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).

Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. (NCT00085735)
Timeframe: 4 -15 months post diagnosis

InterventionScores on a scale (Mean)
Low-dose Craniospinal Radiation (LDSCI)93.8
Standard-dose Craniospinal Radiation (SDCSI)96.2

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Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)

Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. (NCT00085735)
Timeframe: 49 - 72 months post diagnosis

InterventionT-score (Mean)
Low-dose Craniospinal Radiation (LDSCI)54.1
Standard-dose Craniospinal Radiation (SDCSI)58.6

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Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)

Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. (NCT00085735)
Timeframe: 27-48 months post diagnosis

InterventionT-score (Mean)
Low-dose Craniospinal Radiation (LDSCI)51.4
Standard-dose Craniospinal Radiation (SDCSI)55.0

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Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)

Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. (NCT00085735)
Timeframe: 4 - 15 months post diagnosis

InterventionT-score (Mean)
Low-dose Craniospinal Radiation (LDSCI)50.7
Standard-dose Craniospinal Radiation (SDCSI)51.3

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Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4

Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used. (NCT00085735)
Timeframe: Up to 3 years

InterventionPercentage of pts with g3+ hearing loss (Number)
Low-dose Craniospinal Radiation (LDSCI)11
Standard-dose Craniospinal Radiation (SDCSI)11

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Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays

PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. (NCT00085735)
Timeframe: 3 years

InterventionPercentage probability of PFS (Number)
Group 3 Medulloblastoma70.6
Group 4 Medulloblastoma90.6
Sonic Hedgehog (SHH) Medulloblastoma90.4
Wingless (WNT) Medulloblastoma98.4

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Overall Survival (OS)

OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy [IFRT]) are combined and compared to arms II, IV and VI (posterior fossa irradiation [PFRT]). (NCT00085735)
Timeframe: 3 years

,
InterventionProbability of 3 yr OS rate (Number)
LDCSI vs SDCSI
Low-dose Craniospinal Radiation (LDSCI)85.5
Standard-dose Craniospinal Radiation (SDCSI)90.4

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Overall Survival (OS)

OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy [IFRT]) are combined and compared to arms II, IV and VI (posterior fossa irradiation [PFRT]). (NCT00085735)
Timeframe: 3 years

,
InterventionProbability of 3 yr OS rate (Number)
IFRT vs PFRT
Involved Field Radiation (IFRT)90.3
Posterior Fossa Radiation (PFRT)93.3

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Event-free Survival (EFS)

EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's). (NCT00085735)
Timeframe: Assessed at 3 years

,
Interventionprobability of 3 year EFS (Number)
LDCSI vs SDCSI
Low-dose Craniospinal Radiation (LDSCI)76.3
Standard-dose Craniospinal Radiation (SDCSI)84.9

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Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)

Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 27 - 48 months post diagnosis. (NCT00085735)
Timeframe: 27-48 months post diagnosis

InterventionPercentage of Participants (Number)
Eligible and Evaluable Patients32

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Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)

Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 49 - 72 months post diagnosis. (NCT00085735)
Timeframe: 49 - 72 months post diagnosis

InterventionPercentage of Participants (Number)
Eligible and Evaluable Patients69

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Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group

Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests. (NCT00085735)
Timeframe: Post-treatment up to 3 years

InterventionPercentage of patients (Number)
Involved Field Radiation (IFRT)0.0
Posterior Fossa Radiation (PFRT)50.0

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Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4

Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated. (NCT00085735)
Timeframe: Up to 3 years

InterventionPercentage of pts with g3+ hearing loss (Number)
Involved Field Radiation (IFRT)8
Posterior Fossa Radiation (PFRT)8

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Local Posterior Fossa (LPF) Failure Rate

LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events. (NCT00085735)
Timeframe: 3 years

Interventionpercentage 3 yr cumulative incidence (Number)
Involved Field Radiation (IFRT)1.4
Posterior Fossa Radiation (PFRT)2.7

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Non-local Posterior Fossa (NLPF) Failure Rate

NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events. (NCT00085735)
Timeframe: 3 years

InterventionPercentage of 3 yr cumulative incidence (Number)
Involved Field Radiation (IFRT)6.9
Posterior Fossa Radiation (PFRT)2.7

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Non-posterior Fossa (NPF) Failure Rate

NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events. (NCT00085735)
Timeframe: 3 years

InterventionPercentage of 3 yr cumulative incidence (Number)
Involved Field Radiation (IFRT)5.1
Posterior Fossa Radiation (PFRT)6.2

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Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays

OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. (NCT00085735)
Timeframe: 3 years

InterventionPercent probability of overall survival (Number)
Group 3 Medulloblastoma76.3
Group 4 Medulloblastoma97.3
Sonic Hedgehog (SHH) Medulloblastoma92.0
Wingless (WNT) Medulloblastoma98.3

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Post-treatment Endocrine Function by CSI Group

Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported. (NCT00085735)
Timeframe: Up to 3 years

InterventionuU/ml (Mean)
Low-dose Craniospinal Radiation (LDSCI)5.3
Standard-dose Craniospinal Radiation (SDCSI)6.1

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Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)

Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 4 - 15 months post diagnosis. (NCT00085735)
Timeframe: 4-15 months post diagnosis

InterventionPercentage of Participants (Number)
Eligible and Evaluable Patients58

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2-year Progression-free Survival Rate

Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients. (NCT00096174)
Timeframe: assessed every 3 months for 2 years

Interventionproportion of participants (Number)
Cisplatin, C225, Radiation47

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2-year Overall Survival Rate

Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients. (NCT00096174)
Timeframe: assessed very 3 months for 2 years

Interventionproportion of participants (Number)
Cisplatin, C225, Radiation66

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Overall Response Rate

Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients (NCT00096174)
Timeframe: assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry

Interventionproportion of participants (Number)
Cisplatin, C225, Radiation66.7

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Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment

Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason. (NCT00101582)
Timeframe: During the 7 weeks of chemotherapy treatment

Interventionparticipants (Number)
Placebo42
Palifermin49

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Number of Participants With Unplanned Breaks in Radiotherapy

Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy. (NCT00101582)
Timeframe: During the 7 weeks of radiotherapy

Interventionparticipants (Number)
Placebo11
Palifermin13

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Patient-Reported Mouth and Throat Soreness Score

"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).~For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments." (NCT00101582)
Timeframe: Assessed twice a week for up to 15 weeks.

Interventionunits on a scale (Mean)
Placebo1.86
Palifermin1.66

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Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis

"Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure.~Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM." (NCT00101582)
Timeframe: Up to 15 weeks

Interventiondays (Median)
Placebo35.0
Palifermin47.0

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Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks

"The total dose of opioid analgesics (mg of intravenous [IV] morphine equivalents) used by all participants.~Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents." (NCT00101582)
Timeframe: Up to 15 weeks

Interventionmg of IV morphine equivalents (Mean)
Placebo1219.55
Palifermin1243.31

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Number of Participants With Severe (Grade 3 or 4) Oral Mucositis

Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral & lateral tongue; left ventral & lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. (NCT00101582)
Timeframe: Up to Week 15

,
Interventionparticipants (Number)
YesNoUnknown
Palifermin51430
Placebo62293

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Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)

The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale. (NCT00101582)
Timeframe: Month 4

,
Interventionparticipants (Number)
YesNoUnknown
Palifermin373126
Placebo571918

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Duration of Severe (WHO Grade 3 or 4) Oral Mucositis

The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study. (NCT00101582)
Timeframe: Up to 15 weeks

Interventiondays (Median)
Placebo26.0
Palifermin5.0

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The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.

(NCT00102531)
Timeframe: 4 to 48 weeks

,
Interventionparticipants (Number)
CR/PRHistological response
Cisplatin Liposomal 24 mg/m221
Cisplatin Liposomal 36 mg/m221

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Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status

Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. (NCT00122460)
Timeframe: at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt cycle 3Month 6
Cetuximab Plus Chemotherapy50.7452.6855.30
Chemotherapy Alone45.1545.4842.49

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Quality of Life Assessment (EORTC QLQ-C30) Social Functioning

Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning. (NCT00122460)
Timeframe: at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt cycle 3Month 6
Cetuximab Plus Chemotherapy62.1464.6461.27
Chemotherapy Alone62.0560.6765.72

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Best Overall Response

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria). (NCT00122460)
Timeframe: evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Interventionpercentage of participants (Number)
Cetuximab Plus Chemotherapy35.6
Chemotherapy Alone19.5

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Disease Control

The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria). (NCT00122460)
Timeframe: evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Interventionpercentage of participants (Number)
Cetuximab Plus Chemotherapy81.1
Chemotherapy Alone60.0

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Duration of Response

"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria." (NCT00122460)
Timeframe: time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy5.6
Chemotherapy Alone4.7

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Overall Survival Time (OS)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. (NCT00122460)
Timeframe: time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy10.1
Chemotherapy Alone7.4

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Progression-free Survival Time (PFS)

"Duration from randomization until radiological progression according to investigator (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment." (NCT00122460)
Timeframe: time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy5.6
Chemotherapy Alone3.3

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Safety - Number of Patients Experiencing Any Adverse Event

Please refer to Adverse Events section for further details (NCT00122460)
Timeframe: time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007

Interventionparticipants (Number)
Cetuximab Plus Chemotherapy218
Chemotherapy Alone208

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Time to Treatment Failure

"Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment." (NCT00122460)
Timeframe: Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy4.8
Chemotherapy Alone3.0

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Percentage of Patients With Overall Survival

"Overall survival is time from randomization until death from any cause.~Will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Participants will be assessed for up to 10 years. 5 year overall survival is provided as a summary." (NCT00134030)
Timeframe: From date of randomization to date of death.

InterventionPercentage of participants (Number)
MAP-GR84
MAPifn84
MAP-PR68
MAPIE68

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Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Percentages of patients experiencing grade 3 and 4 adverse events. These will be compared using chi-square tests or Fisher's exact tests where appropriate. (NCT00134030)
Timeframe: Adverse events are assessed for up to 10 years per participant.

InterventionParticipants (Count of Participants)
MAP-GR348
MAPifn340
MAP-PR287
MAPIE281

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Event-free Survival (EFS)

"EFS is defined as time from randomisation to the first of: death, detection of local recurrence or metastasis, progression of metastatic disease, or detection of a secondary malignancy.~EFS will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Follow up per participant will be assessed for up to 10 years. The 3 year EFS is provided as a summary." (NCT00134030)
Timeframe: From date of randomization to date of the event.

InterventionPercentage EFS (Number)
MAP-GR74
MAPifn77
MAP-PR55
MAPIE53

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Duration of Response (DR)

DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method. (NCT00143455)
Timeframe: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)

Interventionmonths (Median)
Irinotecan + Cisplatin (Cohort 2)5.5195
Etoposide + Cisplatin (Cohort 2)4.8953

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Number of Subjects With Overall Confirmed Response

Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00143455)
Timeframe: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)

Interventionparticipants (Number)
Irinotecan + Cisplatin (Cohort 2)79
Etoposide + Cisplatin (Cohort 2)94

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Overall Survival (OS) for the Full Analysis Population (FAP)

OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method. (NCT00143455)
Timeframe: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)

Interventionmonths (Median)
Irinotecan + Cisplatin (Cohort 2)10.2177
Etoposide + Cisplatin (Cohort 2)9.6591

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Overall Survival for the Per Protocol (PP) Population

OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method. (NCT00143455)
Timeframe: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)

Interventionmonths (Median)
Irinotecan + Cisplatin (Cohort 2)10.5791
Etoposide + Cisplatin (Cohort 2)9.4292

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Time to Tumor Progression (TTP)

TTP was defined as the time from date of randomization to the date of the first documentation of tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method. (NCT00143455)
Timeframe: Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression)

Interventionmonths (Median)
Irinotecan + Cisplatin (Cohort 2)5.3552
Etoposide + Cisplatin (Cohort 2)6.2423

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Disease Control Rate

The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria). (NCT00148798)
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionpercentage of participants (Number)
Cetuximab Plus Chemotherapy72.5
Chemotherapy Alone71.5

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Best Overall Response Rate

The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). (NCT00148798)
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionpercentage of participants (Number)
Cetuximab Plus Chemotherapy36.4
Chemotherapy Alone29.2

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A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations

Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011. (NCT00148798)
Timeframe: Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.

Interventionug/mL (Mean)
Cetuximab Concentration at End of Infusion Week 1223.1
Cetuximab Concentration Before Infusion Week 751.5

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Quality of Life Assessment (EORTC QLQ-C30) Social Functioning

Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning. (NCT00148798)
Timeframe: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt cycle 3At month 6
Cetuximab Plus Chemotherapy66.1758.0567.36
Chemotherapy Alone64.7367.1366.47

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Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status

Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. (NCT00148798)
Timeframe: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt cycle 3At month 6
Cetuximab Plus Chemotherapy45.7248.3354.71
Chemotherapy Alone46.3651.5552.92

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Safety - Number of Patients Experiencing Any Adverse Event

Please refer to Adverse Events section for further details (NCT00148798)
Timeframe: time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionparticipants (Number)
Cetuximab Plus Chemotherapy545
Chemotherapy Alone549

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Progression-free Survival Time

"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment." (NCT00148798)
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy4.8
Chemotherapy Alone4.8

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Overall Survival Time (OS)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. (NCT00148798)
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy11.3
Chemotherapy Alone10.1

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2-Year Survival

Percentage of participants alive at 2 years. (NCT00191139)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine40.6
Gemcitabine Plus Docetaxel55.7

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Number of Patients With Overall Tumor Response

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR). (NCT00191139)
Timeframe: randomization and every 3 months up to 2 years of post-study followup

Interventionparticipants (Number)
Gemcitabine24
Gemcitabine Plus Docetaxel27

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Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization

LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met. (NCT00191139)
Timeframe: baseline to 3 months after last dose of study treatment (three 21-day cycles)

,
Interventionparticipants (Number)
ImprovementStableWorse
Gemcitabine8102
Gemcitabine Plus Docetaxel598

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Progression-Free Survival

Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed. (NCT00191139)
Timeframe: baseline to measured progressive disease up to 2057 days

Interventiondays (Median)
Gemcitabine162.5
Gemcitabine Plus Docetaxel408.0

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Overall Survival

Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact. (NCT00191139)
Timeframe: baseline to date of death from any cause up to 2057 days

Interventiondays (Median)
Gemcitabine492.5
Gemcitabine Plus Docetaxel899.0

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Progression-free Survival (PFS)

"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions." (NCT00253370)
Timeframe: Assessed every 6 weeks until disease progression or up to 3 years

InterventionMonths (Median)
BAY 43-9006, Docetaxel, Cisplatin5.8

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The Proportion of Patients With Objective Response (Complete Response or Partial Response)

Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR. (NCT00253370)
Timeframe: Assessed every 6 weeks until disease progression or up to 3 years

InterventionProportion of patients (Number)
BAY 43-9006, Docetaxel, Cisplatin0.409

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Overall Survival (OS)

Overall survival was defined as the time from registration to death from any cause. (NCT00253370)
Timeframe: Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry.

InterventionMonths (Median)
BAY 43-9006, Docetaxel, Cisplatin13.6

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Number of Patients in Whom Tumor Was Resectable

Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle. (NCT00262951)
Timeframe: Up to 5 Years or Until Disease Progression

InterventionParticipants (Number)
Pancreatic Adenocarcinoma Patients7

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Overall Survival

In all patients, measured from the date of the patient's registration in this study, until the date of the patient's death or date last known alive (if observation was censored). (NCT00262951)
Timeframe: Up to 5 Years or Date of Death, Whichever Occurred First

InterventionMonths (Median)
Pancreatic Adenocarcinoma Patients11.5

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Two Year Event-free Survival (EFS)

The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate. (NCT00274937)
Timeframe: Up to Two Year After Enrollment

InterventionEstimated probability (Number)
Stratum II0.87

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Protective Effects of Amifostine Assessed Primarily by Sialometry

Weight of stimulated saliva production in grams. (NCT00274937)
Timeframe: At study enrollment

InterventionGrams of saliva (Mean)
At study EnrollmentAt end of consolidation
Stratum II4.973.39

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Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.

Weight of unstimulated saliva production in grams. (NCT00274937)
Timeframe: At study enrollment

InterventionGrams of saliva (Mean)
At study EnrollmentAt end of consolidation
Stratum II3.372.30

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Complications Associated With Radical Adrenalectomy and RLND

Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication. (NCT00304070)
Timeframe: Up to 1 month after surgery

Interventionparticipants (Number)
All Patients1

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Five Year Event-free Survival (EFS)

The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure. (NCT00304070)
Timeframe: Up to five years after enrollment

InterventionEstimated probability five year EFS (Number)
Stratum 10.86
Stratum 20.53
Stratum 30.51

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Frequency of Lymph Node Involvement by Imaging.

The number eligible patients who have lymph node involvement by imaging at study enrollment. (NCT00304070)
Timeframe: At study enrollment

InterventionParticipants (Count of Participants)
All Patients71

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Frequency of Tumor Spillage at the Time of Tumor Resection

The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection. (NCT00304070)
Timeframe: Up to one year or while on protocol therapy, whichever is less

InterventionParticipants (Count of Participants)
All Patients15

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Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.

The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group. (NCT00304070)
Timeframe: At study enrollment

Interventionparticipants (Number)
C229R mutation in p53 in Patients from BrazilC229R mutation in Patients not from BrazilE180K mutation in p53 in Patients from BrazilE180K mutation in Patients not from BrazilG245C mutation in p53 in Patients from BrazilG245C mutation in Patients not from BrazilI254T mutation in p53 in Patients from BrazilI254T mutation in Patients not from BrazilL265Q mutation in p53 in Patients from BrazilL265Q mutation in Patients not from BrazilP47S mutation in p53 in Patients from BrazilP47S mutation in Patients not from BrazilQ52fs mutation in p53 in Patients from BrazilQ52fs mutation in Patients not from BrazilR158L mutation in Patients from BrazilR158L mutation in Patients not from BrazilG245S mutation in Patients from BrazilG245S mutation in Patients not from BrazilR213P mutation in p53 in Patients from BrazilR213P mutation in Patients not from BrazilR248L mutation in Patients from BrazilR248L mutation in Patients not from BrazilR282W mutation in p53 in Patients from BrazilR282W mutation in p53 in Patients not from BrazilR283H mutation in p53 in Patients from BrazilR283H mutation in p53 in Patients not from BrazilR337H mutation in p53 in Patients from BrazilR337H mutation in p53 in Patients not from BrazilR342X mutation in p53 in Patients from BrazilR342X mutation in p53 in Patients not from BrazilT125T c375G>A muation in p53 in Pts from BrazilT125T c375G>A mutation in p53 in pts not from BrazT125T splice in DBD in pts from BrazilT125T splice in DBD in pts not from Brazilwild type p53 in Patients from Brazilwild type p53 in Patients not from Brazil
All Patients020101100101010101010101031200011101116

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Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.

The number of eligible patients who have A43 del33bp mutation of (beta)-catenin. (NCT00304070)
Timeframe: Patients who had surgery at time of enrollment.

InterventionParticipants (Count of Participants)
children with ACT - wild type (beta)-cateninA43 del33bp mutation of (beta)-catenin
All Patients511

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Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy (NCT00304070)
Timeframe: Up to 182 Days After Enrollment

Interventionparticipants (Number)
Incidence of Abdominal InfectionIncidence of Abdominal PainIncidence of AcidosisActivated Partial Thromboplastin Time ProlongedIncidence of Adrenal InsufficiencyIncidence of Alanine Aminotransferase IncreasedIncidence of Allergic ReactionIncidence of AnemiaIncidence of AnorexiaIncidence of Aspartate Aminotransferase IncreasedIncidence of Blood Bilirubin IncreasedIncidence of Cardiac Disorders - Other, SpecifyIncidence of Catheter Related InfectionIncidence of ColitisIncidence of ConfusionIncidence of DehydrationIncidence of Depressed Level of ConsciousnessIncidence of DiarrheaIncidence of DyspneaIncidence of Enterocolitis InfectiousIncidence of EsophagitisIncidence of Febrile NeutropeniaIncidence of FeverIncidence of Gastrointestinal Disorders - Other, SIncidence of Generalized Muscle WeaknessIncidence of GGT IncreasedIncidence of Hearing ImpairedIncidence of Heart FailureIncidence of HyperglycemiaIncidence of HyperkalemiaIncidence of HypertensionIncidence of HypocalcemiaIncidence of HypoglycemiaIncidence of HypokalemiaIncidence of HypomagnesemiaIncidence of HyponatremiaIncidence of HypophosphatemiaIncidence of HypotensionIncidence of HypoxiaIncidence of Infections and Infestations - Other,Incidence of INR IncreasedIncidence of Left Ventricular Systolic DysfunctionIncidence of Lung InfectionIncidence of Lymphocyte Count DecreasedToxicity Associated with MitotaneIncidence of Mucositis OralIncidence of NauseaIncidence of Neutrophil Count DecreasedIncidence of Obstruction GastricIncidence of PainIncidence of Peripheral Motor NeuropathyIncidence of Peripheral Sensory NeuropathyIncidence of PharyngitisIncidence of Platelet Count DecreasedIncidence of PneumonitisIncidence of Premature MenopauseIncidence of Rash Maculo-papularIncidence of SepsisIncidence of Skin InfectionIncidence of Sore ThroatIncidence of Upper Respiratory InfectionIncidence of Urinary Tract InfectionIncidence of Vascular Access ComplicationIncidence of Ventricular ArrhythmiaIncidence of VomitingIncidence of White Blood Cell DecreasedIncidence of Wound Infection
Stratum 3121152122721231131121216121161331319274237121246520111112031121111215161

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Survival Post Treatment

Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates (NCT00304278)
Timeframe: 22 months

Interventionparticipants (Number)
RADPLAT and Tarceva12

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3-year Colostomy-free Survival Rate

Colostomy-free survival was defined as time from registration until time of colostomy or death without colostomy, censoring cases without colostomy at the data of last disease assessment documenting the patient was free of colostomy. Kaplan-Meier method was used to estimate the 3-year colostomy-free survival rate. (NCT00316888)
Timeframe: assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3

Interventionproportion of participants (Number)
Arm I (Closed to Accrual as of 11/3/2008)0.849
Arm II (Open to Accrual on 8/18/2009)0.657

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3-year Overall Survival Rate

Overall survival (OS) is defined as time from registration to death from any cause. Patients alive are censored at the last contact date. Kaplan-Meier method was used to estimate the 3-year OS rate. (NCT00316888)
Timeframe: assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3

Interventionproportion of participants (Number)
Arm I (Closed to Accrual as of 11/3/2008)0.887
Arm II (Open to Accrual on 8/18/2009)0.789

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Local Failure Rate at 3 Years

Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it. (NCT00316888)
Timeframe: assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3

Interventionproportion of participants (Number)
Arm I (Closed to Accrual as of 11/3/2008)0.259
Arm II (Open to Accrual on 8/18/2009)0.353

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Objective Response Rate

Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s). (NCT00316888)
Timeframe: Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST

Interventionproportion of participants (Number)
Arm I (Closed to Accrual as of 11/3/2008)0.630
Arm II (Open to Accrual on 8/18/2009)0.647

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3-year Progression-free Survival Rate

Progression-free survival (PFS) was defined as time from registration to disease progression, relapse or death (whichever occurred first), censoring cases without PFS events at the date of last disease assessment documenting the patient was free of progression/relapse. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the 3-year PFS rate. (NCT00316888)
Timeframe: assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3

Interventionproportion of participants (Number)
Arm I (Closed to Accrual as of 11/3/2008)0.809
Arm II (Open to Accrual on 8/18/2009)0.616

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Disease-free Survival

Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment. (NCT00324805)
Timeframe: From registration to death, up to 10 years

Interventionmonths (Median)
Arm I (Chemotherapy)42.9
Arm II (Chemotherapy, Bevacizumab)40.6

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Overall Survival

Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint. (NCT00324805)
Timeframe: From registration to death, up to 10 years

Interventionmonths (Median)
Arm I (Chemotherapy)NA
Arm II (Chemotherapy, Bevacizumab)85.8

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Rate of Overall Survival at Five Years

Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (NCT00331760)
Timeframe: From randomization to five years

Interventionpercentage of participants (Number)
Endometrial Cancer: IMRT88
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)92

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Rate of Local-regional Failure at Five Years

Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method. (NCT00331760)
Timeframe: From registration to five years.

Interventionpercentage of participants (Number)
Endometrial Cancer: IMRT5
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)8

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Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)

"Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.~For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%." (NCT00331760)
Timeframe: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.

Interventionparticipants (Number)
Endometrial Cancer: IMRT1
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)0

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Percentage of Patients With Grade 2+ Bowel Adverse Events

Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. (NCT00331760)
Timeframe: From the start of treatment to 90 days.

Interventionpercentage of participants (Number)
Endometrial Cancer: IMRT27.9
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)22.5

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Rate of Distant Metastases at Five Years

Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary. (NCT00331760)
Timeframe: From registration to five years

Interventionpercentage of participants (Number)
Endometrial Cancer: IMRT7
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)14

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Rate of Disease-free Survival at Five Years

Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. (NCT00331760)
Timeframe: From registration five years

Interventionpercentage of participants (Number)
Endometrial Cancer: IMRT88
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)84

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Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant

Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites. (NCT00331760)
Timeframe: From start to end of chemotherapy, approximately five weeks from registration.

Interventionpercentage of participants (Number)
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)80

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Overall Survival

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00334815)
Timeframe: Every week, up to 4 years

InterventionMonths (Median)
Low Risk Patient Stratum46
High Risk Patient Stratum17

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Progression-free Survival

From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00334815)
Timeframe: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.

InterventionMonths (Median)
Low Risk Patient Stratum38
High Risk Patient Stratum15

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Adverse Events

Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00334815)
Timeframe: Up to one year

,
InterventionParticipants (Number)
Acidosis (metabolic or respiratory)Arthritis (non-septic)Calcium, serum-low (hypocalcemia)Carbon monoxide diffusion capacity (DL(co))CreatinineDehydrationDyspnea (shortness of breath)EsophagitisFEV(1)Febrile neutropeniaGlucose, serum-high (hyperglycemia)HemoglobinHemorrhage, Respiratory tract NOSHemorrhage, GI - Peritoneal cavityHemorrhage, pulmonary/upper respiratory - LungHypotensionHypoxiaINR (of prothrombin time)Inf (clin/microbio) w/Gr 3-4 neuts - NoseInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gumsInf (clin/microbio) w/Gr 3-4 neuts - UTIInf (clin/microbio) w/Gr 3-4 neuts - Upper airwayInf w/normal ANC or Gr 1-2 neutrophils - BloodInf w/normal ANC or Gr 1-2 neutrophils - LungLeukocytes (total WBC)LymphopeniaMuscle weakness, not d/t neuropathy - body/generalNauseaNeutrophils/granulocytes (ANC/AGC)Pain - Chest wallPain - Chest/thorax NOSPain - Head/headachePain - JointPain - NeckPain - Throat/pharynx/larynxPlateletsPneumonitis/pulmonary infiltratesPotassium, serum-low (hypokalemia)Pulmonary/Upper Respiratory-Other (Specify)Rash/desquamationRash: dermatitis associated w/radiationSodium, serum-low (hyponatremia)Weight loss
Concurrent Chemotherapy and Radiotherapy00011112131200010111101162121011101121301110
Consolidation Therapy With Docetaxel and Bevacizumab.1110001000021110100001000310000010002110001

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Response Rate (Confirmed or Unconfirmed Partial Response)

Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. (NCT00334815)
Timeframe: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration

Interventionpercentage of participants (Number)
Low Risk Patient Stratum64
High Risk Patient Stratum70

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Number of Participants With Chronic Central Hypothyroidism

"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than Institutional Normal with TSH less than or equal to Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)1

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Number of Participants With Chronic Diabetes Insipidus

"The number of patients who had Diabetes Insipidus and on DDAVP will be reported for this analysis due to small numbers.." (NCT00336024)
Timeframe: Beginning of off-treatment to up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)1

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Number of Participants With Chronic Low Somatomedin C

Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run. (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))2
Arm II (Patients Treated With MTX)5

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Rates of Nutritional Toxicities

Rates of nutritional toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with nutritional toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

,
InterventionParticipants (Count of Participants)
Nutritional Disorders Induction Cycle INo Nutritional Disorders Induction Cycle INutritional Disorders Induction Cycle IINo Nutritional Disorders Induction Cycle IINutritional Disorders Induction Cycle IIINo Nutritional Disorders Induction Cycle IIINutritional Disorders Consolidation Cycle INo Nutritional Disorders Consolidation Cycle INutritional Disorders Consolidation Cycle IINo Nutritional Disorders Consolidation Cycle IINutritional Disorders Consolidation Cycle IIINo Nutritional Disorders Consolidation Cycle III
Arm I (Patients Treated Without Methotrexate (MTX))1029132673212279301029
Arm II (Patients Treated With MTX)172113251226830533533

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Rates of Gastrointestinal Toxicities

Rates of gastrointestinal toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

,
InterventionParticipants (Count of Participants)
GI Tox Induction Cycle INo GI Tox Induction Cycle IGI Tox Induction Cycle IINo GI Tox Induction Cycle IIGI Tox Induction Cycle IIINo GI Tox Induction Cycle IIIGI Tox Consolidation Cycle INo GI Tox Consolidation Cycle IGI Tox Consolidation Cycle IINo GI Tox Consolidation Phase IIGI Tox Consolidation Cycle IIINo GI Tox Consolidation Cycle III
Arm I (Patients Treated Without Methotrexate (MTX))8314354351128732534
Arm II (Patients Treated With MTX)1226102883014241028632

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Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).

"Three tools are used to assess intelligence (IQ) depending on age. The range of IQ scores is 40-160 (mean=100, SD=15); range for the Processing Speed Index (PSI)=45-155. Higher scores represent better functioning. (1) Wechsler Preschool and Primary Scale of Intelligence-4th Edition (WPPSI-IV) is used for ages 2.5 to 6 years. Bug Search and Cancellation subtests are summed to calculate PSI. (2) Wechsler Intelligence Scales for Children-5th Edition (WISC-V) is used for ages 6 - 16 years. Symbol Search and Coding subtests are summed to calculate PSI. (3) Wechsler Adult Intelligence Scales-4th Edition (WAIS-IV) is used for ages 16 and older. Symbol Search and Coding subtests are summed to calculate PSI.~The Pediatric Quality of Life Inventory Version 4 (PedsQL) measures health-related quality of life (QOL). Parents complete the measure for children ages 2-17, and patients > 18 complete a self-report version. Total scores range from 0-100, with higher scores representing better QOL." (NCT00336024)
Timeframe: 60 months (+/- 3 months)

,
Interventionscores on a scale (Median)
Total Quality of Life ScoreIntelligence QuotientProcessing Speed Index
Arm I (Patients Treated Without Methotrexate (MTX))60.577.082.0
Arm II (Patients Treated With MTX)56.578.589.0

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Percentage of Participants With Event Free Survival (EFS)

EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 90% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1. (NCT00336024)
Timeframe: Baseline to up to 5 years

Interventionpercentage of participants with EFS (Number)
Arm I (Patients Treated Without Methotrexate (MTX))43.6
Arm II (Patients Treated With MTX)54.9

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Percentage of Participants With Any Acute Adverse Events

Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

Interventionpercentage of participants (Number)
Arm I (Patients Treated Without Methotrexate (MTX))97.4
Arm II (Patients Treated With MTX)97.2

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Number of Participants With Secondary Malignancies

The number of patients who had secondary malignancy will be reported for this analysis due to small numbers. (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)0

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Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism

"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than Institutional Normal or equal to Institutional Normal with TSH level greater than Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))3
Arm II (Patients Treated With MTX)5

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Duration of Oral Mucositis as Measured in Terms of Days

"Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days [15 weeks] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0.~This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05.~Statistical testing was not done due to the small sample size." (NCT00360971)
Timeframe: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

InterventionDays (Mean)
Placebo32
Palifermin13

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Time to Second Primary Tumor

An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported. (NCT00360971)
Timeframe: From randomization to maximum follow-up at time of analysis of 21 months

InterventionParticipants (Count of Participants)
Placebo0
Palifermin0

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Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. (NCT00360971)
Timeframe: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

InterventionParticipants (Count of Participants)
Placebo8
Palifermin4

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Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. (NCT00360971)
Timeframe: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

Interventiondays (Mean)
Placebo48
Palifermin41

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Progression-free Survival

An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported. (NCT00360971)
Timeframe: From randomization to maximum follow-up at time of analysis of 21 months

InterventionParticipants (Count of Participants)
Placebo2
Palifermin0

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Overall Survival

An event is death from any cause. Overall survival was not calculated due to the limited number of events. Number of patients with an event is reported. (NCT00360971)
Timeframe: From randomization to maximum follow-up at time of analysis of 21 months

InterventionParticipants (Count of Participants)
Placebo2
Palifermin0

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Overall Survival (Three-year Rate Reported)

Overall survival time is defined as time from registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (NCT00369122)
Timeframe: From registration to 3 years

Interventionpercentage of participants (Number)
Treatment (Radiation Therapy, Bevacizumab, Cisplatin)81.3

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Disease-free Survival (Three-year Rate Reported)

Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact. (NCT00369122)
Timeframe: From registration to 3 years

Interventionpercentage of participants (Number)
Treatment (Radiation Therapy, Bevacizumab, Cisplatin)68.7

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Overall Survival in Patients With Adenocarcinoma

Overall survival (OS) was defined as the time from study entry to death of any cause. The median OS with 95% CI was estimated using the Kaplan Meier method. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionmonths (Median)
Arm A: Adenocarcinoma (ECF + Cetuximab)11.6
Arm B: Adenocarcinoma (IC + Cetuximab)8.6
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)11.8

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Progression-free Survival in Patients With Adenocarcinoma

Progression free survival (PFS) was defined as the time from study entry to progression or death of any cause. The median PFS with 95% CI was estimated using the Kaplan Meier method. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionmonths (Median)
Arm A: Adenocarcinoma (ECF + Cetuximab)7.1
Arm B: Adenocarcinoma (IC + Cetuximab)4.9
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)6.8

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Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionpercentage of participants (Number)
Arm A: Adenocarcinoma (ECF + Cetuximab)61
Arm B: Adenocarcinoma (IC + Cetuximab)45
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)54

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Time to Treatment Failure in Patients With Adenocarcinoma

Time to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity. The median TTF with 95% CI was estimated using the Kaplan Meier method. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionmonths (Median)
Arm A: Adenocarcinoma (ECF + Cetuximab)5.6
Arm B: Adenocarcinoma (IC + Cetuximab)4.3
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)6.7

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Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionpercentage of participants (Number)
Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)67
Arm B: Squamous Cell Carcinoma (IC + Cetuximab)13
Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)60

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Overall Objective Response Rate (CR + PR)

Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment. (NCT00388154)
Timeframe: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.

Interventionpercentage of participants (Number)
Gemcitabine + Cisplatin50

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Participant Responses

Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD. (NCT00388154)
Timeframe: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.

Interventionparticipants (Number)
CRPRPDSD
Gemcitabine + Cisplatin2846

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The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for SPNET Patients

Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 60+/-12 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 48 - 72 months post diagnosis

Interventionscore on a scale (Mean)
Regimen A (SPNET Patients)94.8
Regimen B (SPNET Patients)48.0
Regimen C (SPNET Patients)87.0
Regimen D (SPNET Patients)79.7

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The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for SPNET Patients

Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 30+/-6 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 24 - 36 months post diagnosis

InterventionScore on a scale (Mean)
Regimen A (SPNET Patients)83.3
Regimen B (SPNET Patients)57.5
Regimen C (SPNET Patients)83.7
Regimen D (SPNET Patients)88.5

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Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma

The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined. (NCT00392327)
Timeframe: Up to 5 years

InterventionPercent Probability (Number)
Regimen A (Medulloblastoma Patients)66.0
Regimen B (Medulloblastoma Patients)75.9
Regimen C (Medulloblastoma Patients)69.9
Regimen D (Medulloblastoma Patients)81.6

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Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)

The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. (NCT00392327)
Timeframe: Up to 5 years

InterventionPercent Probability (Number)
Regimen A (SPNET Patients)52.2
Regimen B (SPNET Patients)52.6
Regimen C (SPNET Patients)19
Regimen D (SPNET Patients)63

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Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma

The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined. (NCT00392327)
Timeframe: Up to 5 years

InterventionPercent Probability (Number)
Regimen A (Medulloblastoma Patients)57.5
Regimen B (Medulloblastoma Patients)65.3
Regimen C (Medulloblastoma Patients)60.3
Regimen D (Medulloblastoma Patients)70.9

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Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)

Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses. SPNET is no longer recognized by WHO (World Health Organization) as a disease entity. Additional trial information can be found under PubMed® # 30332335. (NCT00392327)
Timeframe: 12 weeks after treatment initiation

Interventionpercentage of patients (Number)
Regimen A (SPNET Patients)69.9
Regimen B (SPNET Patients)83.3
Regimen C (SPNET Patients)66.7
Regimen D (SPNET Patients)73.7

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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients

Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis

InterventionT-Score (Mean)
Regimen A (Medulloblastoma Patients)50.9
Regimen B (Medulloblastoma Patients)50.2
Regimen C (Medulloblastoma Patients)50.8
Regimen D (Medulloblastoma Patients)47.5

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The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients

Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis

InterventionScore on a scale (Mean)
Regimen A (SPNET Patients)84.6
Regimen B (SPNET Patients)80.3
Regimen C (SPNET Patients)99.3
Regimen D (SPNET Patients)90.6

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Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)

The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact. (NCT00392327)
Timeframe: Up to 5 years

InterventionPercent Probability (Number)
Regimen A (SPNET Patients)60.9
Regimen B (SPNET Patients)57.9
Regimen C (SPNET Patients)35.3
Regimen D (SPNET Patients)77.0

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Tumor Response to Radiation Therapy for Patients With Medulloblastoma

Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses. (NCT00392327)
Timeframe: 12 weeks after treatment initiation

Interventionpercentage of patients (Number)
Regimen A (Medulloblastoma Patients)75.9
Regimen B (Medulloblastoma Patients)78.8
Regimen C (Medulloblastoma Patients)72.9
Regimen D (Medulloblastoma Patients)81.8

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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients

Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 48 - 72 months post diagnosis

InterventionT-Score (Mean)
Regimen A (SPNET Patients)56.0
Regimen B (SPNET Patients)64.0
Regimen C (SPNET Patients)71.5
Regimen D (SPNET Patients)53.7

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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for SPNET Patients

Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 24 - 36 months post diagnosis

InterventionT-Score (Mean)
Regimen A (SPNET Patients)53.5
Regimen B (SPNET Patients)75.5
Regimen C (SPNET Patients)64.5
Regimen D (SPNET Patients)53.5

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The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients

Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis

InterventionScore on a scale (Mean)
Regimen A (Medulloblastoma Patients)96.6
Regimen B (Medulloblastoma Patients)89.1
Regimen C (Medulloblastoma Patients)83.5
Regimen D (Medulloblastoma Patients)94.8

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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for SPNET Patients

Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis

InterventionT-Score (Mean)
Regimen A (SPNET Patients)53.8
Regimen B (SPNET Patients)66.7
Regimen C (SPNET Patients)46.1
Regimen D (SPNET Patients)64.3

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10-month Progression-Free Survival Rate

10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. (NCT00394433)
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.

Interventionprobability (%) (Number)
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)40.0

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Overall Survival

Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods. (NCT00394433)
Timeframe: Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).

Interventionmonths (Median)
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)14.9

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Best Response

Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria. (NCT00394433)
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).

Interventionparticipants (Number)
Partial ResponseStable DiseaseProgressive Disease
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)2375

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Progression-Free Survival

Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. (NCT00394433)
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).

Interventionmonths (Median)
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)8.9

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Time to Treatment Failure (TTF)

The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first. (NCT00400179)
Timeframe: From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.

InterventionMonths (Median)
S-1/Cisplatin3.8
5-FU/Cisplatin3.8

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Progression-free Survival (PFS)

The time from randomization to date of first documented PD or date of death, whichever occurred first. (NCT00400179)
Timeframe: From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.

InterventionMonths (Median)
S-1/Cisplatin4.8
5-FU/Cisplatin5.5

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Overall Response Rate (ORR)

The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. (NCT00400179)
Timeframe: Data cutoff was 07 March 2008 (12 months after last patient randomized).

InterventionPercentage of patients in each group (Number)
S-1/Cisplatin29.1
5-FU/Cisplatin31.9

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Median Survival

Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient. (NCT00400179)
Timeframe: The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).

InterventionMonths (Median)
S-1/Cisplatin8.6
5-FU/Cisplatin7.9

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Duration of Response (DR)

Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions. (NCT00400179)
Timeframe: Data cutoff was 07 March 2008 (12 months after last patient was randomized).

InterventionMonths (Median)
S-1/Cisplatin6.5
5-FU/Cisplatin5.8

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One- and Two-year Distant Metastases-free Rates

Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk. (NCT00408694)
Timeframe: From registration to two years

Interventionpercentage of participants (Number)
One-yearTwo-year
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)97.790.8

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One- and Two-year Loco-regional Progression-free Rates

Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk. (NCT00408694)
Timeframe: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.

Interventionpercentage of participants (Number)
One-yearTwo-year
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)93.274.7

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Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen

Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals. (NCT00408694)
Timeframe: From start of treatment to end of treatment (approximately day 109).

Interventionpercentage of participants (Number)
Concurrent componentAdjuvant component
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)68.268.2

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Death During or Within 30 Days of Discontinuation of Protocol Treatment.

The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval. (NCT00408694)
Timeframe: From start of treatment to 30 days after end of treatment (treatment ends approximately day 109).

Interventionpercentage of participants (Number)
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)0

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One- and Two-year Progression-free Survival Rates

Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases. (NCT00408694)
Timeframe: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.

Interventionpercentage of participants (Number)
One-yearTwo-year
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)90.974.7

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One- and Two-year Overall Survival Rates

Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause. (NCT00408694)
Timeframe: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.

Interventionpercentage of participants (Number)
One-yearTwo-year
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)93.290.9

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Number of Participants With Overall Tumor Response

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs. (NCT00453154)
Timeframe: Up to 3 years

,
Interventionparticipants (Number)
Complete ResponsePartial Response
Arm I (Combination Chemotherapy + Sunitinib Maintenance)34
Arm II (Combination Chemotherapy + Placebo Maintenance)05

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Progression-free Survival (Phase II)

Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. (NCT00453154)
Timeframe: Up to 3 years

Interventionmonths (Median)
Arm I (Combination Chemotherapy + Sunitinib Maintenance)3.7
Arm II (Combination Chemotherapy + Placebo Maintenance)2.1

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Overall Survival

Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. (NCT00453154)
Timeframe: Up to 3 years

Interventionmonths (Median)
Arm I (Combination Chemotherapy + Sunitinib Maintenance)9.0
Arm II (Combination Chemotherapy + Placebo Maintenance)6.9

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Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)

The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy). (NCT00453154)
Timeframe: 21 days

Interventionmg/day (Number)
Cohort 125

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Time to Response

Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventiondays (Mean)
Cisplatin / Capecitabine132.92
Epirubicin / Cisplatin / Capecitabine126.64
Epirubicin / Oxaliplatin / Capecitabine123.50
Docetaxel / Cisplatin / Capecitabine138.16

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Progression-Free Survival (PFS)

PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventionmonths (Median)
Cisplatin / Capecitabine4.43
Epirubicin / Cisplatin / Capecitabine5.17
Epirubicin / Oxaliplatin / Capecitabine7.07
Docetaxel / Cisplatin / Capecitabine7.87

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Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)

(NCT00454636)
Timeframe: Approximately 3.25 years

Interventionpercentage of participants (Number)
Cisplatin / Capecitabine2.4
Epirubicin / Cisplatin / Capecitabine6.3
Epirubicin / Oxaliplatin / Capecitabine3.7
Docetaxel / Cisplatin / Capecitabine5.2

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Overall Survival (OS)

OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventionmonths (Median)
Cisplatin / Capecitabine10.23
Epirubicin / Cisplatin / Capecitabine8.87
Epirubicin / Oxaliplatin / Capecitabine13.87
Docetaxel / Cisplatin / Capecitabine12.43

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Duration of Response

Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventiondays (Mean)
Cisplatin / Capecitabine308.92
Epirubicin / Cisplatin / Capecitabine154.09
Epirubicin / Oxaliplatin / Capecitabine203.06
Docetaxel / Cisplatin / Capecitabine205.52

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Overall Response Rate (ORR)

ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventionpercentage of participants (Number)
Cisplatin / Capecitabine43.3
Epirubicin / Cisplatin / Capecitabine40.7
Epirubicin / Oxaliplatin / Capecitabine69.6
Docetaxel / Cisplatin / Capecitabine59.6

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Apparent Oral Clearance (CL/F) for Capecitabine

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

InterventionLiter/hr (Mean)
Axitinib + Capecitabine (Cohort 6)209.05
Axitinib + Capecitabine (Cohort 7)314.12

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Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

InterventionLiter/hour (L/hr) (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)49.39
Axitinib + Paclitaxel + Carboplatin (Cohort 2)40.72
Axitinib + Paclitaxel + Carboplatin (Cohort 3)29.73
Axitinib + Paclitaxel (Cohort 4)65.69
Axitinib + Docetaxel (Cohort 5)14.35
Axitinib + Capecitabine (Cohort 6)26.64
Axitinib + Capecitabine (Cohort 7)83.46
Axitinib + Gemcitabine + Cisplatin (Cohort 8)50.05
Axitinib + Pemetrexed + Cisplatin (Cohort 9)25.10

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Plasma Clearance (CL) for Carboplatin

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

InterventionL/hr (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)12.57

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Plasma Decay Half Life (t1/2) for Pemetrexed

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

Interventionhr (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)2.77

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Plasma Decay Half Life (t1/2) for Paclitaxel

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

Interventionhr (Mean)
Axitinib + Paclitaxel (Cohort 4)12.51
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)8.36

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Plasma Decay Half Life (t1/2) for Gemcitabine

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

Interventionhr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)0.29

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Plasma Decay Half Life (t1/2) for Docetaxel

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

Interventionhr (Mean)
Axitinib + Docetaxel (Cohort 5)11.49

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Plasma Decay Half Life (t1/2) for Cisplatin

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

Interventionhr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)2.61
Axitinib + Pemetrexed + Cisplatin (Cohort 9)3.91

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Plasma Decay Half Life (t1/2) for Carboplatin

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

Interventionhr (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)2.62

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Plasma Decay Half Life (t1/2) for Capecitabine

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

Interventionhr (Mean)
Axitinib + Capecitabine (Cohort 6)0.85
Axitinib + Capecitabine (Cohort 7)1.44

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Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

Interventionhr (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)2.75
Axitinib + Paclitaxel + Carboplatin (Cohort 2)2.90
Axitinib + Paclitaxel + Carboplatin (Cohort 3)2.80
Axitinib + Paclitaxel (Cohort 4)1.45
Axitinib + Docetaxel (Cohort 5)4.07
Axitinib + Capecitabine (Cohort 6)3.85
Axitinib + Capecitabine (Cohort 7)3.64
Axitinib + Gemcitabine + Cisplatin (Cohort 8)2.68
Axitinib + Pemetrexed + Cisplatin (Cohort 9)5.02

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Plasma Clearance (CL) for Pemetrexed

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

InterventionL/hr (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)7.26

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Plasma Clearance (CL) for Paclitaxel

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

InterventionL/hr (Mean)
Axitinib + Paclitaxel (Cohort 4)30.48
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)21.61

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Plasma Clearance (CL) for Gemcitabine

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

InterventionL/hr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)224.36

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Plasma Clearance (CL) for Docetaxel

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

InterventionL/hr (Mean)
Axitinib + Docetaxel (Cohort 5)42.96

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Plasma Clearance (CL) for Cisplatin

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

InterventionL/hr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)46.31
Axitinib + Pemetrexed + Cisplatin (Cohort 9)46.80

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Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00454649)
Timeframe: Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks

InterventionPercentage of Participants (Number)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)100.0
Axitinib + Paclitaxel + Carboplatin (Cohort 2)0
Axitinib + Paclitaxel + Carboplatin (Cohort 3)35.0
Axitinib + Paclitaxel (Cohort 4)66.7
Axitinib + Docetaxel (Cohort 5)50.0
Axitinib + Capecitabine (Cohort 6)11.1
Axitinib + Capecitabine (Cohort 7)11.8
Axitinib + Gemcitabine + Cisplatin (Cohort 8)23.8
Axitinib + Pemetrexed + Cisplatin (Cohort 9)0

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Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy

MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity. (NCT00454649)
Timeframe: Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]

Interventionmg BID (Number)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)5
Axitinib + Paclitaxel + Carboplatin (Cohort 2)5
Axitinib + Paclitaxel + Carboplatin (Cohort 3)5
Axitinib + Paclitaxel (Cohort 4)5
Axitinib + Docetaxel (Cohort 5)NA
Axitinib + Capecitabine (Cohort 6)5
Axitinib + Capecitabine (Cohort 7)5
Axitinib + Gemcitabine + Cisplatin (Cohort 8)5
Axitinib + Pemetrexed + Cisplatin (Cohort 9)5

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Maximum Observed Plasma Concentration (Cmax) for Pemetrexed

(NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

Interventionng/mL (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)83925.00

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Maximum Observed Plasma Concentration (Cmax) for Paclitaxel

(NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

Interventionng/mL (Mean)
Axitinib + Paclitaxel (Cohort 4)3698.33
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)6105.00

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Maximum Observed Plasma Concentration (Cmax) for Gemcitabine

(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

Interventionng/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)20635.29

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Maximum Observed Plasma Concentration (Cmax) for Docetaxel

(NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

Interventionng/mL (Mean)
Axitinib + Docetaxel (Cohort 5)3130.00

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Maximum Observed Plasma Concentration (Cmax) for Cisplatin

(NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

Interventionng/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)1680.54
Axitinib + Pemetrexed + Cisplatin (Cohort 9)1176.00

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Maximum Observed Plasma Concentration (Cmax) for Carboplatin

(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

Interventionng/mL (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)23383.33

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Maximum Observed Plasma Concentration (Cmax) for Capecitabine

(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

Interventionng/mL (Mean)
Axitinib + Capecitabine (Cohort 6)10808.00
Axitinib + Capecitabine (Cohort 7)10588.38

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Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)

(NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

Interventionng/mL (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)5.97
Axitinib + Paclitaxel + Carboplatin (Cohort 2)23.36
Axitinib + Paclitaxel + Carboplatin (Cohort 3)42.58
Axitinib + Paclitaxel (Cohort 4)44.58
Axitinib + Docetaxel (Cohort 5)67.96
Axitinib + Capecitabine (Cohort 6)37.51
Axitinib + Capecitabine (Cohort 7)43.97
Axitinib + Gemcitabine + Cisplatin (Cohort 8)40.97
Axitinib + Pemetrexed + Cisplatin (Cohort 9)31.53

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Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin

AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8). (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

Interventionng*hr/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)2932.43
Axitinib + Pemetrexed + Cisplatin (Cohort 9)2703.92

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Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine

AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

Interventionng*hr/mL (Mean)
Axitinib + Capecitabine (Cohort 6)20534.52
Axitinib + Capecitabine (Cohort 7)22163.88

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Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)

AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)61.58
Axitinib + Paclitaxel + Carboplatin (Cohort 2)242.41
Axitinib + Paclitaxel + Carboplatin (Cohort 3)475.18
Axitinib + Paclitaxel (Cohort 4)154.43
Axitinib + Docetaxel (Cohort 5)780.99
Axitinib + Capecitabine (Cohort 6)365.95
Axitinib + Capecitabine (Cohort 7)449.99
Axitinib + Gemcitabine + Cisplatin (Cohort 8)416.30
Axitinib + Pemetrexed + Cisplatin (Cohort 9)420.64

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

Interventionng*hr/mL (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)133032.97

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

Interventionng*hr/mL (Mean)
Axitinib + Paclitaxel (Cohort 4)5683.55
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)19959.91

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

Interventionng*hr/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)10991.16

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

Interventionng*hr/mL (Mean)
Axitinib + Docetaxel (Cohort 5)3478.49

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

Interventionng*hr/mL (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)55580.26

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Duration of Response (DOR) During the Second-line Treatment Phase

Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 57 months

InterventionMonths (Median)
Chemotherapy AloneNA

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Overall Survival (OS) for the Second-line Treatment

Time from the first dose of panitumumab monotherapy to the date of death during the entire study (NCT00454779)
Timeframe: Until death, up to 57 months

InterventionMonths (Median)
Chemotherapy Alone8.5

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Progression Free Survival (PFS) During the First-line Treatment Phase

The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 67 months

InterventionMonths (Median)
Panitumumab Plus Chemotherapy6.9
Chemotherapy Alone5.5

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Progression Free Survival (PFS) During the Second-line Treatment Phase

The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 57 months

InterventionMonths (Median)
Chemotherapy Alone4.2

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Overall Response Rate (ORR) During the Second-line Treatment Phase

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 57 months

InterventionPercentage of Participants (Mean)
Chemotherapy Alone13.33

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Rate of Disease Control (RDC) During the First-line Treatment Phase

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 67 months

InterventionPercentage of Participants (Mean)
Panitumumab Plus Chemotherapy80.77
Chemotherapy Alone72.55

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Rate of Disease Control (RDC) During the Second-line Treatment Phase

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 57 months

InterventionPercentage of Participants (Mean)
Chemotherapy Alone53.33

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Time to Response (TTR) During the First-line Treatment Phase

Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter) (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 67 months

InterventionWeeks (Mean)
Panitumumab Plus Chemotherapy8.8
Chemotherapy Alone10.6

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Duration of Response (DOR) During the First-line Treatment Phase

Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 67 months

InterventionMonths (Median)
Panitumumab Plus Chemotherapy8.0
Chemotherapy Alone5.1

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Time to Response (TTR) During the Second-line Treatment Phase

Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter) (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 57 months

InterventionWeeks (Mean)
Chemotherapy Alone10.6

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Overall Survival (OS) for the First-line Treatment

Time from the date of randomization to the date of death during the entire study (NCT00454779)
Timeframe: Until death, up to 67 months

InterventionMonths (Median)
Panitumumab Plus Chemotherapy12.9
Chemotherapy Alone13.8

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Overall Response Rate (ORR) During the First-line Treatment Phase

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. (NCT00454779)
Timeframe: Every 6 weeks until disease progression or death, up to 67 months

InterventionPercentage of Participants (Mean)
Panitumumab Plus Chemotherapy44.23
Chemotherapy Alone37.25

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Best Overall Response (BOR)

Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). (NCT00463788)
Timeframe: Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009

Interventionpercentage of participants (Number)
Cisplatin and Cetuximab20.0
Cisplatin10.3

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Overall Survival (OS) Time

The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier. (NCT00463788)
Timeframe: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010

Interventionmonths (Median)
Cisplatin and Cetuximab12.9
Cisplatin9.4

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Progression-Free Survival (PFS) Time

The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment. (NCT00463788)
Timeframe: Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009

Interventionmonths (Median)
Cisplatin and Cetuximab3.7
Cisplatin1.5

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Safety- Number of Participants Experiencing Any Adverse Event (AE)

Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. (NCT00463788)
Timeframe: Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010

Interventionparticipants (Number)
Cisplatin and Cetuximab114
Cisplatin57

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Time to Response (TTR)

The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR. (NCT00463788)
Timeframe: Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009

Interventionmonths (Median)
Cisplatin and Cetuximab1.4
Cisplatin1.3

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Number of Participants That Experienced Adverse Effects Grade 3 or Higher

Number of treated participants with adverse events of grade 3 or higher. Graded by Common Terminology Criteria for Adverse Events version 3.0. Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. (NCT00492778)
Timeframe: Maximum follow-up for adverse events was 61 months.

InterventionParticipants (Count of Participants)
Treated Regimen I37
Treated Regimen II49

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Number of Participants That Experienced Death on Study

Overall survival is the period from study entry until death or date of last contact. The treatment regimens were compared with regard to overall survival. (NCT00492778)
Timeframe: Participants were followed from study entry until death or date of last contact. Median follow-up for overall survival was 62 months with a maximum of 128 months.

InterventionParticipants (Count of Participants)
Arm I (Brachytherapy, Radiation Therapy)18
Arm II (Brachytherapy, Radiation Therapy, Cisplatin)21

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Number of Participants With Disease Progression or Death.

The number of participants with disease progression or death from study entry to progression or death. Participants who experienced progression or death were reported by treatment arm. (NCT00492778)
Timeframe: Median follow-up for progression-free survival was 62 months with a maximum of 128 months. Patients were followed from study entry until disease progression, death, or date of last contact

InterventionParticipants (Count of Participants)
Arm I (Brachytherapy, Radiation Therapy)27
Arm II (Brachytherapy, Radiation Therapy, Cisplatin)35

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Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.

Participants were put in prognostic groups including baseline factors of tumor location (vagina only vs. all others) and histology (serious and clear cell vs. all others). They were assessed for prognostic associations with progression-free survival. Participant factors were collected at baseline. Participants were followed from study entry until disease progression, death, or date of last contact for progression-free survival. (NCT00492778)
Timeframe: Median follow-up for progression-free survival was 62 months with a maximum of 128 months.

InterventionParticipants (Count of Participants)
Prognostic Group 145
Prognostic Group 24
Prognostic Group 30
Prognostic Group 413

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Time to Progression (TTP)

TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. (NCT00505635)
Timeframe: Following two 21 day cycles until disease progression

Interventiondays (Geometric Mean)
Biochemotherapy With Temozolomide93.2

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Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen

"Number of participants out of total with a response defined as downstaging to <= pT1N0 in the resected specimen. A binary variable was defined for downstaging (pathologic stage below initial clinical stage and below pT1N1N0M0); staging using American Joint Committee on Cancer (AJCC) TNM system of TNM; T describes size tumor & cancer spread into nearby tissue; N describes spread to nearby lymph nodes; & M describes metastasis (spread to other parts of body). Numbers after T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures, higher the T number, the larger the tumor and/or more it has grown into nearby tissues. Responses of lesser magnitude scored as treatment failure. Response Evaluation Criteria In Solid Tumors (RECIST) criteria do not apply for this cohort of neoadjuvant participants since this study does not require measurable disease by traditional assessment." (NCT00506155)
Timeframe: Following 20 weeks of chemotherapy

InterventionPercentage of Participants (Number)
pT0N0pT1N0
Neoadjuvant Chemotherapy With M-VAC + Avastin3853

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5-year Overall Survival (OS)

The overall survival rate stated as a five-year survival rate, which is the percentage of participants in study who are alive five years after the start of treatment. (NCT00506155)
Timeframe: 5 years

InterventionPercentage of Participants (Number)
Neoadjuvant Chemotherapy With M-VAC + Avastin63

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Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)

The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84. (NCT00509366)
Timeframe: Baseline, Every 21 days for a maximum of 6 cycles

Interventionunits on a scale (Mean)
Change from baseline to Cycle 1Change from baseline to Cycle 2Change from baseline to Cycle 3Change from baseline to Cycle 4Change from baseline to Cycle 5Change from baseline to Cycle 6
Treatment0.15-1.04-1.28-2.62-6.14-0.72

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1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients

One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive. (NCT00509366)
Timeframe: 1 year

Interventionpercentage of treated patients (Number)
Treatment19.15

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Median Time to Progressive Disease

Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented. (NCT00509366)
Timeframe: 1 Year

Interventionmonths (Number)
Treatment4.60

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Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.

CTCAE assessment of toxicity (NCT00511992)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Avastin2

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Number of Patients Able to Complete 6 Cycles of Treatment.

Completion of cycle 6 (NCT00511992)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Avastin17

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Number of Participants With Pathologic Complete Remission (pCR)

Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions. (NCT00512096)
Timeframe: restaging with second and fourth 21-day cycles followed by surgery

Interventionparticipants (Number)
Cisplatin + Ifosfamide + Paclitaxel3

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6 Month Progression Free Survival (PFS)

"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate" (NCT00515411)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Interventionpercentage of paticipants (Mean)
Arm A, - Modified DCF63
ARM B - Parent DCF With G-CSF53
Arm C - Modified DCF+ Trastuzumab73

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Overall Survival

Overall survival measured in months (NCT00515411)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 months

Interventionmonths (Median)
Arm A, - Modified DCF18.8
ARM B - Parent DCF With G-CSF12.6
Arm C - Modified DCF+ Trastuzumab24.9

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Complete Pathologic Response

Per pathology review post surgery (NCT00522795)
Timeframe: At Surgery approximately 4weeks after last treatment

Interventionparticipants (Number)
PPX, Cisplatin, Radiation12

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Phase 2: Time to Progressive Disease (PD)

Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation. (NCT00529100)
Timeframe: Baseline to measured PD (up to 3 years)

Interventionmonths (Median)
Pemetrexed/Cisplatin/Radiation Phase 213.7

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Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year

OS was defined as the time from date of enrollment to death due to any cause. (NCT00529100)
Timeframe: Baseline to date of death from any cause (up to 1 year)

Interventionpercentage of participants (Number)
Pemetrexed/Cisplatin/Radiation Phase 279.0

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Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy

Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration. (NCT00529100)
Timeframe: Baseline to measured progressive disease (PD; up to 1 year)

Interventionmilligrams per square meter (mg/m^2) (Number)
Concurrent Phase MTD: PemetrexedConcurrent Phase MTD: CisplatinConsolidation Phase MTD: PemetrexedConsolidation Phase MTD: Cisplatin
Pemetrexed/Cisplatin/Radiation Phase 15002050075

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Phase 2: Site of Progressive Disease (PD)

Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. (NCT00529100)
Timeframe: Baseline to measured PD (up to 3 years)

Interventionparticipants (Number)
Local/RegionalDistantLocal + DistantUnknown
Pemetrexed/Cisplatin/Radiation Phase 281711

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Phase 2: Percentage of Participants With Progression Free Survival (PFS)

The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD. (NCT00529100)
Timeframe: Baseline and 1 year and 2 years and 3 years

Interventionpercentage of participants (Number)
1 Year2 Years3 Years
Pemetrexed/Cisplatin/Radiation Phase 248.730.820.2

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Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years

OS was defined as the time from date of enrollment to death due to any cause. (NCT00529100)
Timeframe: Baseline and 2 years and 3 years

Interventionpercentage of participants (Number)
2 years3 years
Pemetrexed/Cisplatin/Radiation Phase 256.446.2

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Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)

Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR. (NCT00529100)
Timeframe: Baseline to measured PD (up to 3 years)

Interventionpercentage of participants (Number)
Complete ResponsePartial Response
Pemetrexed/Cisplatin/Radiation Phase 2045.95

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Phase 1: Number of Participants With Adverse Events (AE; Toxicity)

A listing of AEs is located in the Reported Adverse Event module. (NCT00529100)
Timeframe: Baseline to measured PD (up to 1 year)

Interventionparticipants (Number)
Serious Adverse Events (SAEs)Other Non-serious Adverse Events (AEs)
Pemetrexed/Cisplatin/Radiation Phase 1510

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Progression Free Survival (PFS)

PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment). (NCT00529100)
Timeframe: Baseline to measured PD (up to 36 months)

Interventionmonths (Median)
Pemetrexed/Cisplatin/Radiation Phase 211.8

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Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy

The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies. (NCT00545948)
Timeframe: 4 years

InterventionPercentage of participants (Number)
All Registered Patients77.4

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2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC

Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive. (NCT00545948)
Timeframe: 2 years

Interventionpercentage of treated patients (Number)
Treatment63.64

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2-Year Overall Survival in Patients Treated for NSCLC

Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive (NCT00545948)
Timeframe: 2 years

Interventionpercentage of treated patients (Number)
Treatment81.81

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ORR by 6 Months - Central

ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response. (NCT00547157)
Timeframe: From randomization to 6 months

InterventionProporation of Participants (Number)
Panitumumab Plus Radiotherapy0.722
Chemoradiotherapy0.767

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Overall Survival

Time from first dose date to death (NCT00547157)
Timeframe: maximum follow up time 46.2 months

Interventionmonths (Median)
Panitumumab Plus Radiotherapy41.7
ChemoradiotherapyNA

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Local Regional Control Rate at 2 Years

Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator's assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports). (NCT00547157)
Timeframe: from study day 1 to 2 years

InterventionProportion of Participants (Number)
Panitumumab Plus Radiotherapy0.51
Chemoradiotherapy0.61

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Progression-free Survival

Time from first dose date till disease progression or death (NCT00547157)
Timeframe: maximum follow up time 46.2 months

Interventionmonths (Median)
Panitumumab Plus Radiotherapy17.3
ChemoradiotherapyNA

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Duration of Local Regional Control

Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first) (NCT00547157)
Timeframe: maximum follow up time 46.2 months

Interventionmonths (Median)
Panitumumab Plus Radiotherapy25.1
ChemoradiotherapyNA

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CRR by 6 Months - Central

CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions. (NCT00547157)
Timeframe: From randomization till 6 months

InterventionProportion of Participants (Number)
Panitumumab Plus Radiotherapy0.144
Chemoradiotherapy0.117

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Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Grade 3 and higher toxicities will be descriptively summarized. (NCT00554788)
Timeframe: Up to 30 days after completion of study treatment

,,
Interventionpercentage of participants (Number)
Abdominal painAcute kidney injuryAlanine aminotransferase increasedAnemiaAnorexiaApneaAspartate aminotransferase increasedCatheter related infectionDehydrationDepressed level of consciousnessDiarrheaEncephalopathyEnterocolitisEnterocolitis infectiousEsophagitisFebrile neutropeniaFeverGGT increasedGastric hemorrhageHearing impairedHypermagnesemiaHypertensionHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemiaHypotensionHypoxiaInfections and infestations - Other, specifyLower gastrointestinal hemorrhageLung infectionLymphocyte count decreasedMucositis oralNauseaNervous system disorders - Other, specifyNeutrophil count decreasedOral painPainPeripheral motor neuropathyPharyngeal mucositisPlatelet count decreasedPneumonitisRectal painSeizureSepsisSinus tachycardiaSinusitisSkin infectionUpper respiratory infectionVomitingWhite blood cell decreased
Stage 2/3 Patients000011.10011.1005.6005.6055.611.10011.15.6005.6027.85.611.122.20027.8016.705.616.705.6005.605.65.6000011.1011.111.15.6
Stage 4a Patients5.65.616.7033.3011.1011.1016.705.611.15.655.605.65.65.605.605.6016.75.60011.12.633.35.60027.811.1005.65.605.6005.6011.15.605.65.622.20
Stage 4b Patients005.35.315.85.35.3010.55.305.305.3036.85.3005.3005.310.55.321.110.515.810.50021.1005.35.35.310.55.300005.3005.30005.305.35.3

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Response Rate to the Induction Phase of the Regimen

This study used a modified version of the international criteria for neuroblastoma response. The response rate to the induction phase of the regimen and a corresponding 95% confidence interval will be calculated for all strata combined. (NCT00554788)
Timeframe: 12 weeks after participant received the first dose

Interventionpercentage of participants (Number)
All Eligible Patients68

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Event-free Survival (EFS)

The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause. (NCT00554788)
Timeframe: At 1 year

InterventionProbability (Number)
Stage 2/3 Patients88
Stage 4a Patients83
Stage 4b Patients28

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Percentage of Participants With Serious Adverse Events

Determine the frequency and severity of toxicities of the intensification regimen. Patients will be evaluated for local and systemic toxicity/morbidity from treatment regimen. (NCT00566540)
Timeframe: Up to one year

Interventionpercentage of patients (Number)
LeukocytesRashColitisDehydrationDiarrheaVomitingHemorrhage, Upper RespiratoryInfection with normal ANCEdema
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9991899999

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Treatment Completion

Patients are to be seen at Ohio State Medical center for a physical exam every 2 months for the first year. (NCT00566540)
Timeframe: up to one year

Interventionpatients (Number)
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)7

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Incidence Rate of Local Recurrence

Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation. (NCT00567567)
Timeframe: Up to 3 years

InterventionPercentage 3-year cumulative incidence (Number)
Single HST (CEM)15.7

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Intraspinal Extension

Percentage of patients with primary tumors with intraspinal extension. (NCT00567567)
Timeframe: Up to 5 years

InterventionPercentage of patients (Number)
Single HST (CEM)8.25
Tandem HST (CEM), Randomly Assigned9.66
Not Assigned7.78

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OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology

Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated. (NCT00567567)
Timeframe: Up to 3 years

Interventionpercent probability (Number)
Single HST (CEM)81.0

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Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies

Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532 (NCT00567567)
Timeframe: Day 1 of each course

InterventionMicromolar (Median)
Single HST (CEM)1.00
Tandem HST (CEM), Randomly Assigned1.36
Not Assigned1.26

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Event-free Survival Rate

Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM) (NCT00567567)
Timeframe: Three years, from time of randomization

Interventionpercent probability (Number)
Single HST (CEM)48.8
Tandem HST (CEM), Randomly Assigned61.8

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Proportion of Patients With a Polymorphism

A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population. (NCT00567567)
Timeframe: Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days

InterventionProportion of patients (Number)
Single HST (CEM)0.96
Tandem HST (CEM), Randomly Assigned0.96
Not Assigned0.97

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Response After Induction Therapy

Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion (primary or metastases) with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive. (NCT00567567)
Timeframe: Study enrollment to the end of induction therapy

InterventionProportion participants that responded (Number)
Single HST (CEM)0.54
Tandem HST (CEM), Randomly Assigned0.48
Not Assigned0.35

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Surgical Response

Percentage of patients who achieved a surgical complete resection (NCT00567567)
Timeframe: Up to 3 years

InterventionPercentage of patients (Number)
Single HST (CEM)83.98
Tandem HST (CEM), Randomly Assigned84.09
Not Assigned58.89

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Topotecan Systemic Clearance

Median topotecan systemic clearance for courses 1 and 2. (NCT00567567)
Timeframe: Day 1 of courses 1-2

InterventionL/h/m2 (Median)
Single HST (CEM)28.1
Tandem HST (CEM), Randomly Assigned28.1
Not Assigned28.5

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Duration of Greater Than or Equal to Grade 3 Neutropenia

A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism. (NCT00567567)
Timeframe: Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days

InterventionDays (Median)
Single HST (CEM)7
Tandem HST (CEM), Randomly Assigned7
Not Assigned7

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Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells

A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed. (NCT00567567)
Timeframe: Up to 6 months after completion of assigned myeloablation therapy

,
Interventioncells/mm^3 (Median)
CD3CD4CD8
Single HST (CEM)20073104
Tandem HST (CEM), Randomly Assigned255.581151

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EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).

Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated. (NCT00567567)
Timeframe: Up to 3 years

Interventionpercent probability (Number)
Single HST (CEM)73.1

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Type of Surgical or Radiotherapy Complication

The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea. (NCT00567567)
Timeframe: Up to 3 years

InterventionPercentage of patients (Number)
Single HST (CEM)13.11
Tandem HST (CEM), Randomly Assigned12.50
Not Assigned11.85

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Duration of Greater Than or Equal to Grade 3 Thrombocytopenia

A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism. (NCT00567567)
Timeframe: Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days

InterventionDays (Median)
Single HST (CEM)4
Tandem HST (CEM), Randomly Assigned4
Not Assigned4

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Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT

"Per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and by Spiral CT assessment:~Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR" (NCT00573131)
Timeframe: Screening and Week 12

Interventionpercentage of patients (Number)
Group 112.5
Group 220.0

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Total Number of Days of Stem Cell Collection (Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionDays (Mean)
Usual Care5.3
Exercise4.0

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Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 30 weeks

,
Interventiong/dl (Mean)
BaselineBefore TransplantationDuring TransplanationAt Discharge
Exercise11.712.010.811.0
Usual Care11.512.010.810.9

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Total Number of Days of Stem Cell Collection (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionDays (Mean)
Usual Care4.9
Exercise4.5

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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionPlatelet transfusions (Mean)
Usual Care3.1
Exercise2.3

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Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 30 weeks

InterventionRBC Transfusions (Mean)
Usual Care1.8
Exercise1.0

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Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 15 weeks

InterventionRBC Transfusions (Mean)
Usual Care2.3
Exercise1.8

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Number of Stem Cell Collection Attempts (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionStem Cell Collection Attempts (Mean)
Usual Care1.3
Exercise1.1

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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionPlatelet Transfusions (Mean)
Usual Care3.6
Exercise2.0

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Number of Stem Cell Collection Attempts (Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionStem Cell Collection Attempts (Mean)
Usual Care1.4
Exercise1.1

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Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 15 weeks

,
Interventiong/dl (Mean)
BaselineBefore transplantationDuring transplantationAt discharge
Exercise11.611.010.410.6
Usual Care12.110.810.110.6

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Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity

(NCT00582205)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Paclitaxel, Cisplatin IP7

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Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.

(NCT00582205)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Paclitaxel, Cisplatin IP7

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Progression-free Survival (PFS)

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) was defined as the time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who were still alive and progression free were censored at last disease assessment date. Median PFS was estimated using Kaplan-Meier method. (NCT00588770)
Timeframe: on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks

Interventionmonths (Median)
Chemotherapy Arm (Arm A)4.3
Chemotherapy+Bevacizumab (Arm B)6.0

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Overall Survival (OS)

Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method. (NCT00588770)
Timeframe: assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry

Interventionmonths (Median)
Chemotherapy Arm (Arm A)11.0
Chemotherapy+Bevacizumab (Arm B)12.6

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Overall Response Rate

Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s). (NCT00588770)
Timeframe: on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks

Interventionproportion of participants (Number)
Chemotherapy Arm (Arm A)0.245
Chemotherapy+Bevacizumab (Arm B)0.355

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Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. (NCT00590967)
Timeframe: 1 year post start of radiation therapy

,
Interventionparticipants (Number)
NeutropeniaAnorexiaDiarrheaHypomagnesemiaLeukopeniaLymphopeniaDyspneaFatigueHemoglobinHematocritHyperkalemiaHypoglycemiaHyponatremiaInfection without neutropeniaPlateletsRenal failure
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)3111210000000000
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)1110331121111111

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Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)

(NCT00590967)
Timeframe: 30 days after completion of radiation therapy

,
Interventionparticipants (Number)
Absolute neutrophil countAnorexiaAnxietyDiarrheaDyspneaDysuriaFatigueGranulocytes/bandsHemoglobinHematocritVaginal bleedingHyperglycemiaHypermagnesemiaHypertensionHypocalcemiaHypokalemiaHyponatremiaHypomagnesemiaInfection with neutropeniaInfection (Urinalysis)LeukopeniaLymphopeniaNauseaAbdominal painPelvic painPain - not otherwise specified (NOS)packed red blood cell (PRBC) TransfusionPlateletsProteinuriaSkinVomitingWeight lossAlbuminAtrial fibrillationConfusionCreatinineVaginal mucosa erythematousEdemaerythrocyte sedimentation rate (ESR)HyperkalemiaHypoglycemiainternational normalized ratio (INR)Leucocyte esteraseProthrombin time (PT)partial thromboplastin time (PTT)Renal failureaspartate aminotransferase (ALT)Yeast infection
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)61151191211112353111103543245211220000000000000000
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)410510426401000045231025112011202121111111121114111

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Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status

(NCT00590967)
Timeframe: 1st PET scan after completion of treatment (approximately month 6)

,
Interventionparticipants (Number)
Positive PET scanNegative PET scanEquivocal PET scanPET scan not performed
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)62762
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)9740

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Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group1968
Intermediate-Risk Group1504
High-Risk Group868

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Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1

Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose

InterventionL/h/m^2 (Median)
Low-Risk Group2.95
Intermediate-Risk Group2.83
High-Risk Group2.74

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CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group1.59
Intermediate-Risk Group1.65
High-Risk Group1.41

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CEPM AUC0-24h in Induction Chemotherapy

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group140.2
Intermediate-Risk Group137.8
High-Risk Group135.3

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CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group132.7
Intermediate-Risk Group46.8
High-Risk Group44.0

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CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group128.9
Intermediate-Risk Group62.2
High-Risk Group51.8

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4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1

4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group1.98
Intermediate-Risk Group1.96
High-Risk Group1.82

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4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy

4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group116.4
Intermediate-Risk Group111.3
High-Risk Group109.1

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4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2

4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group95.9
Intermediate-Risk Group49.5
High-Risk Group43.5

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4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1

4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group96.8
Intermediate-Risk Group48.7
High-Risk Group39.8

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Methotrexate Volume of Central Compartment in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group12.64
Intermediate-Risk Group13.31
High-Risk Group13.68

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Pharmacogenetic Variation on Central Nervous System Transmitters

Frequencies of genetic polymorphisms were reported. (NCT00602667)
Timeframe: At study enrollment (Day 0)

InterventionParticipants (Count of Participants)
Genetic Polymorphisms for monoamine oxidase A (MAOA) rs632372067969Genetic Polymorphisms for catecholamine-O-methyltransferase (COMT) rs468072067969Genetic Polymorphisms for dopamine receptor D (DRD3) rs628072067969
AGCCTCTTGGAATG
Patients With Neurotransmitter Studies2
Patients With Neurotransmitter Studies13
Patients With Neurotransmitter Studies7
Patients With Neurotransmitter Studies5
Patients With Neurotransmitter Studies0
Patients With Neurotransmitter Studies6
Patients With Neurotransmitter Studies4

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Numbers of Patients With Molecular Abnormalities by Tumor Type

Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,,,,,
InterventionParticipants (Count of Participants)
PTCH1 alterationSUFU alterationKMT2D alterationSMO alterationBCOR alterationPTEN alterationBRCA2 alterationGLI2 alterationSMARCA4 alterationTP53 alterationMYCN amplificationchr2p gain/amplificationchr2p loss/deletionchr2q gain/amplificationchr2q loss/deletionchr6p gain/amplificationchr6p loss/deletionchr6q gain/amplificationchr6q loss/deletionchr8p gain/amplificationchr8p loss/deletionchr8q gain/amplificationchr8q loss/deletionchr9p gain/amplificationchr9p loss/deletionchr9q gain/amplificationchr9q loss/deletionchr10p gain/amplificationchr10p loss/deletionchr10q gain/amplificationchr10q loss/deletionchr20p gain/amplificationchr20p loss/deletionchr20q gain/amplificationchr20q loss/deletion
High-risk Group 3 Patients00000000001101032320706030307080404
High-risk Group 4 Patients00000000000000000000101000000000000
High-risk SHH Patients31310000000404000000000301200010101
Intermediate-risk Group 3 Patients00000000100010120201221100005050303
Intermediate-risk Group 4 Patients00000000000010110100404101000000000
Intermediate-risk SHH Patients41100000001000000000000400500020100
Low-risk SHH Patients76521100200505010101010442600030201

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Numbers of Patients With Gene Alterations

Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,
InterventionParticipants (Count of Participants)
PTCH1 alterationSUFU alterationKMT2D alterationSMO alterationBCOR alterationPTEN alterationBRCA2 alterationGLI2 alterationSMARCA4 alterationTP53 alterationMYCN alteration
High-Risk Group31310000001
Intermediate-Risk Group41100000101
Low-Risk Group76521100200

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Number of Successful Collections for Frozen and Fixed Tumor Samples

Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,
InterventionParticipants (Count of Participants)
Number with frozen tumor tissueNumber with fixed tumor tissue
High-Risk Group3271
Intermediate-Risk Group73153
Low-Risk Group2754

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Number of Participants With Chromosomal Abnormalities

Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,
InterventionParticipants (Count of Participants)
chr2p gain/amplificationchr2p loss/deletionchr2q gain/amplificationchr2q loss/deletionchr6p gain/amplificationchr6p loss/deletionchr6q gain/amplificationchr6q loss/deletionchr8p gain/amplificationchr8p loss/deletionchr8q gain/amplificationchr8q loss/deletionchr9p gain/amplificationchr9p loss/deletionchr9q gain/amplificationchr9q loss/deletionchr10p gain/amplificationchr10p loss/deletionchr10q gain/amplificationchr10q loss/deletionchr20p gain/amplificationchr20p loss/deletionchr20q gain/amplificationchr20q loss/deletion
High-Risk Group606032320807331507090505
Intermediate-Risk Group121230302635601505070403
Low-Risk Group505010101010442600030201

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Number and Type of Genetic Polymorphisms

Types of genetic polymorphisms of neurotransmitters were examined. We studied 3 genetic polymorphisms; these were types of genetic polymorphisms involved in dopamine metabolism. They were as follows: rs6323, rs4680, and rs6280. (NCT00602667)
Timeframe: At study enrollment (Day 0)

InterventionParticipants (Count of Participants)
rs6323rs4680rs6280
Number of Patients With Neurotransmitter Studies171717

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Concentration of Cerebrospinal Fluid Neurotransmitters

Concentrations of various neurotransmitters in cerebrospinal fluid were measured at 5 timepoints. The median concentration of each neurotransmitter at each time point was calculated and provided with a full range. (NCT00602667)
Timeframe: Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date

Interventionng/ml (Median)
Dopamine concentration at baselineDopamine concentration at completion of treatmentDopamine concentration at 12 months off treatmentDopamine concentration at 24 months off treatmentDopamine concentration at 36 months off treatment3,4-dihydroxyphenylacetic acid concentration at baseline3,4-dihydroxyphenylacetic acid concentration at completion of treatment3,4-dihydroxyphenylacetic acid concentration at 12 months off treatment3,4-dihydroxyphenylacetic acid concentration at 24 months off treatment3,4-dihydroxyphenylacetic acid concentration at 36 months off treatmentHydroxytryptamine concentration at baselineHydroxytryptamine concentration at completion of treatmentHydroxytryptamine concentration at 12 months off treatmentHydroxytryptamine concentration at 24 months off treatmentHydroxytryptamine concentration at 36 months off treatmentHydroxyindoleacetic acid concentration at baselineHydroxyindoleacetic acid concentration at completion of treatmentHydroxyindoleacetic acid concentration at 12 months off treatmentHydroxyindoleacetic acid concentration at 24 months off treatmentHydroxyindoleacetic acid concentration at 36 months off treatmentHomovanillic acid concentration at baselineHomovanillic acid concentration at completion of treatmentHomovanillic acid concentration at 12 months off treatmentHomovanillic acid concentration at 24 months off treatmentHomovanillic acid concentration at 36 months off treatment
Patients With Neurotransmitter Studies3.163.706.434.464.052.561.621.041.521.002.382.012.002.441.6252.0352.7235.7233.9831.5682.44114.1368.2888.2779.78

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Topotecan Clearance in Consolidation Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion

InterventionL/h/m^2 (Median)
Intermediate-Risk Group30.3
High-Risk Group26.40

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Topotecan AUC0-24h in Maintenance Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose

Interventionµg·h/L (Median)
Low-Risk Group10.90
Intermediate-Risk Group11.60
High-Risk Group10.33

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Topotecan AUC0-24h in Consolidation Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion

Interventionµg·h/L (Median)
Intermediate-Risk Group117
High-Risk Group116

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Topotecan Apparent Oral Clearance in Maintenance Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.25, 1.5 and 6 hours post-dose

InterventionL/h (Median)
Low-Risk Group41.4
Intermediate-Risk Group41.0
High-Risk Group44.6

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Rate of Local Disease Progression

Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval. (NCT00602667)
Timeframe: 1 year after completion of radiation therapy for last patient

InterventionPercentage of participants (Number)
Intermediate-risk Patients Who Received Focal Radiation13.2

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Rate of Distant Disease Progression

Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval. (NCT00602667)
Timeframe: 1 year after completion of radiation therapy for last patient

Interventionpercentage of participants (Number)
Intermediate-risk Patients Who Received Focal Radiation25.6

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Percentage of Patients With Objective Responses Rate to Induction Chemotherapy

For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response [ PR]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks. (NCT00602667)
Timeframe: From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)

InterventionPercentage of patients (Number)
Intermediate-Risk Group58.3
High-Risk Group21.1

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Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup

Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile. (NCT00602667)
Timeframe: From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment

InterventionPercent Probability (Number)
Low-risk SHH Patients73.9
Intermediate-risk SHH Patients50.0
High-risk SHH Patients54.5
Intermediate-risk Group 3 Patients30.8
High-risk Group 3 Patients9.1
Intermediate-risk Group 4 Patients62.5
High-risk Group 4 Patients50.0

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Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients

Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. (NCT00602667)
Timeframe: From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment

InterventionPercent Probability (Number)
Low-Risk Group73.9
Intermediate-Risk Group46.9
High-Risk Group30.8

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Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients

Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. (NCT00602667)
Timeframe: From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after

InterventionPercent Probability (Number)
Low-Risk Group73.9
Intermediate-Risk Group46.9
High-Risk Group30.8

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Percent of PET Scans With Loss of Signal Intensity

Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay. (NCT00602667)
Timeframe: Up to 3 times during RT consolidation

Interventionmean activation value (MAV) (Mean)
Intermediate Risk Group60

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Percent of Patients With Sustained Objective Responses Rate After Consolidation

For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response. (NCT00602667)
Timeframe: 8 weeks after completion of consolidation therapy (up to 8 months after on-study date)

Interventionpercentage of participants (Number)
High-Risk Group13.2

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Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan

Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion

Interventionparticipants (Number)
Intermediate-Risk Group1
High-Risk Group20

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Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan

Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion

Interventionparticipants (Number)
Intermediate-Risk Group0
High-Risk Group8

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Overall Survival (OS) Compared to Historical Controls

OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. (NCT00602667)
Timeframe: 1 year after treatment initiation of last patient

InterventionPercent probability (Number)
SJYC07 Low-risk Medulloblastoma Patients100
SJYC07 Intermediate-risk Medulloblastoma Patients84.4
SJYC07 High-risk Medulloblastoma Patients61.5

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OSI-420 AUC0-24h

Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group2.17
Intermediate-Risk Group1.81
High-Risk Group1.62

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Methotrexate Volume of Central Compartment in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group12.70
Intermediate-Risk Group13.55
High-Risk Group13.87

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Methotrexate Volume of Central Compartment in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group13.77
Intermediate-Risk Group13.73
High-Risk Group13.62

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Methotrexate Volume of Central Compartment in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group11.63
Intermediate-Risk Group13.70
High-Risk Group13.25

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.64
Intermediate-Risk Group0.64
High-Risk Group0.55

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.65
Intermediate-Risk Group0.70
High-Risk Group0.58

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.75
Intermediate-Risk Group0.72
High-Risk Group0.69

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.49
Intermediate-Risk Group0.57
High-Risk Group0.61

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Methotrexate Clearance in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/h/m^2 (Median)
Low-Risk Group5.75
Intermediate-Risk Group5.89
High-Risk Group5.79

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Methotrexate Clearance in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/h/m^2 (Median)
Low-Risk Group5.68
Intermediate-Risk Group5.78
High-Risk Group5.81

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Methotrexate Clearance in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/h/m^2 (Median)
Low-Risk Group5.47
Intermediate-Risk Group5.70
High-Risk Group5.70

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Methotrexate Clearance in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)

InterventionL/h/m^2 (Median)
Low-Risk Group5.69
Intermediate-Risk Group6.06
High-Risk Group5.65

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Methotrexate AUC0-66h in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1804
Intermediate-Risk Group1841
High-Risk Group1886

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Methotrexate AUC0-66h in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1872
Intermediate-Risk Group1879
High-Risk Group1831

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Methotrexate AUC0-66h in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1900
Intermediate-Risk Group1902
High-Risk Group1879

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Methotrexate AUC0-66h in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1797
Intermediate-Risk Group1813
High-Risk Group1821

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Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity

For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy. (NCT00602667)
Timeframe: From on-study date up to 4 months after on-study date

InterventionPercentage of courses delayed (Number)
High-Risk Group3.8

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Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received

These data are based on patient diaries. For children <3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question. (NCT00602667)
Timeframe: From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)

InterventionPercentage of scheduled doses received (Mean)
Low-Risk Group96
Intermediate-Risk Group91
High-Risk Group98

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Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity

For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy. (NCT00602667)
Timeframe: At completion of consolidation therapy (up to 6 months after on-study date)

InterventionPercentage of courses delayed (Number)
High-Risk Group2.6

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Event-free Survival (EFS) Compared to Historical Controls

EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. (NCT00602667)
Timeframe: From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years

InterventionPercent probability (Number)
SJYC07 Low-risk Medulloblastoma Patients73.9
SJYC07 Intermediate-risk Medulloblastoma Patients46.9
SJYC07 High-risk Medulloblastoma Patients30.8

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Erlotinib AUC0-24h

Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group31.0
Intermediate-Risk Group23.5
High-Risk Group22.0

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Erlotinib Apparent Volume of Central Compartment

Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

InterventionL/m^2 (Median)
Low-Risk Group72.9
Intermediate-Risk Group61.7
High-Risk Group104.8

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Erlotinib Apparent Oral Clearance

Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

InterventionL/h/m^2 (Median)
Low-Risk Group6.53
Intermediate-Risk Group7.79
High-Risk Group8.40

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Cyclophosphamide Clearance in Induction Chemotherapy

Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

InterventionL/h/m^2 (Median)
Low-Risk Group2.40
Intermediate-Risk Group2.23
High-Risk Group2.25

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Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

InterventionL/h/m^2 (Median)
Low-Risk Group2.48
Intermediate-Risk Group2.55
High-Risk Group2.37

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Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

InterventionL/h/m^2 (Median)
Low-Risk Group2.39
Intermediate-Risk Group2.08
High-Risk Group2.43

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Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1

Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group39.9
Intermediate-Risk Group38.7
High-Risk Group42.2

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Cyclophosphamide AUC0-24h in Induction Chemotherapy

Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group2070
Intermediate-Risk Group2150
High-Risk Group2105

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Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group1966
Intermediate-Risk Group799
High-Risk Group899

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Overall Response

"Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level~Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started,~Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions." (NCT00603408)
Timeframe: At the time of surgery (week 13)

Interventionparticipants (Number)
Complete responsePartial responseStable diseaseProgressive disease
Cisplatin + Radiation + Recommended Surgery2300

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Number of Participants With Medical Toxicities

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results. (NCT00603408)
Timeframe: 30 days post surgery (week 17-18)

Interventionparticipants (Number)
Cisplatin + Radiation + Recommended Surgery5

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Number of Participants With Surgical Complications

(NCT00603408)
Timeframe: 30 days post surgery (week 17-18)

Interventionparticipants (Number)
Cisplatin + Radiation + Recommended Surgery0

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Overall Survival Rate (OS)

OS = Time from registration until death from any cause (NCT00603408)
Timeframe: Until study was terminated (23.5 months)

Interventionpercentage of participants (Number)
Cisplatin + Radiation + Recommended Surgery100

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Number of Participants With Disease Progression by Week 12

Disease progression was determined by clinical examination and histopathologic examination by the Investigator. (NCT00626639)
Timeframe: Up to Week 12

Interventionparticipants (Number)
Placebo1
Palifermin0

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Number of Participants With Adverse Events (AEs)

An adverse event is an undesirable medical occurrence (sign, symptom, or diagnosis) or worsening of a pre-existing medical condition occurring after start of study drug up to the end of acute oral mucositis (OM) evaluation phase, whether or not considered to be study drug related. If severe OM was not resolved by Week 12, AEs were documented until resolution of severe OM or Week 15, whichever occurred first. A serious AE is any event that is fatal, life threatening, requires or prolongs hospitalization, is a persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3 based on the following: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death related to AE. A Protocol-specific Limiting Toxicity (PSLT) is any non-hematologic Grade 3 or 4 AE considered related to study drug. (NCT00626639)
Timeframe: Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)

,
Interventionparticipants (Number)
Any adverse eventSerious adverse eventSevere AE (Grade 3, 4 or 5)Treatment related adverse eventTreatment related serious AETreatment related severe AE (Grade 3, 4 or 5)Study Discontinuation Due to AEProtocol Specific Limiting Toxicity (PSLT)Deaths
Palifermin322111001
Placebo200000000

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Overall Survival

Deaths during long-term follow up of subject participating in the acute phase of the study receiving placebo or Palifermin. (NCT00626639)
Timeframe: During long-term follow-up phase, until December 2015

InterventionParticipants (Count of Participants)
Placebo2
Palifermin2

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Number of Patients With Each Worst-grade Toxicity

Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death (NCT00639769)
Timeframe: 6 weeks after last chemotherapy

Interventionparticipants (Number)
No. of patients with worst-grade toxicity of 1No. of patients with worst-grade toxicity of 2No. of patients with worst-grade toxicity of 3No. of patients with worst-grade toxicity of 4No. of patients with worst-grade toxicity of 5
Therapeutic Intervention21221101

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Patient Response

Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. (NCT00639769)
Timeframe: 6 weeks after last chemotherapy treatment

Interventionparticipants (Number)
Partial ResponseProgressive DiseaseStable DiseaseComplete response
Therapeutic Intervention111560

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Event-free Survival

Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT00653068)
Timeframe: Up to 4 years after study enrollment

InterventionEstimated probability (Number)
Stratum I0.3401
Stratum III0.4500

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Overall Survival (OS)

Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored. (NCT00653068)
Timeframe: Up to 4 years after study enrollment

InterventionEstimated Probability (Number)
Stratum I0.3888
Stratum III0.5486

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Toxic Death

The number of patients who experience death that is considered to be primarily attributable to complications of treatment. (NCT00653068)
Timeframe: During and after completion of study treatment up to 1 year after enrollment.

InterventionParticipants (Count of Participants)
Stratum I3
Stratum III1

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Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy

Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy. (NCT00653068)
Timeframe: During protocol therapy up to 1 year after enrollment.

InterventionParticipants (Count of Participants)
AcidosisAcute kidney injuryApneaAdult respiratory distress syndromeAspirationAtelectasisCatheter related infectionCentral nervous system necrosisDehydrationDiarrheaDissmeminated intravascular coagulation (DIC)EnterocolitisFebrile neutropeniaHearing impairmentHematuriaHydrocephalusHypernatremiaHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHyponatremiaHypophosphatemiaHypotensionHypoxiaIncreased Alanine aminotransferaseIncreased Aspartate aminotransferaseIncreased LipaseIntracranial hemorrhagentraoperative venous injuryLaryngospasmLeft ventricular systolic dysfunctionLung infectionMulti-organ failureMucositis oralPoisoning and procedural complicationsOther gastrointestinal disordersOther infectionPneumonitisProductive coughPulmonary edemaRecurrent laryngeal nerve palsyRenal calculiRespiratory failureSeizureSepsisSinus tachycardiaStridorUpper respiratory infectionVascular access complicationVoice alterationVomitingWeight loss
All Patients11213121111161111132922465412111313117211113262211111

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Neurotoxicity Assessment at Cycle 2

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm13.0
Taxane Group: MV + Vitamin B12 + Vitamin B612.0
Heavy Metals Group: Multivitamin (MV) Arm9.7
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm8.4
Vinca Alkaloids Group: Multivitamin (MV) Arm14.56
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm5.6

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Change in Neurotoxicity Assessment Between Cycle 4 and Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm7.0
Taxane Group: MV + Vitamin B12 + Vitamin B67.2
Heavy Metals Group: Multivitamin (MV) Arm3.9
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.7
Vinca Alkaloids Group: Multivitamin (MV) Arm11.8
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm7

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Neurotoxicity Assessment at Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported. (NCT00659269)
Timeframe: At study start; prior to treatment (week 0)

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm8.5
Taxane Group: MV + Vitamin B12 + Vitamin B67.3
Heavy Metals Group: Multivitamin (MV) Arm5.23
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.58
Vinca Alkaloids Group: Multivitamin (MV) Arm6.80
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm2.08

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Neurotoxicity Assessment at Cycle 4

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm14.5
Multivitamin + Vitamin B12 + Vitamin B614.5
Heavy Metals Group: Multivitamin (MV) Arm8.71
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm7.05
Vinca Alkaloids Group: Multivitamin (MV) Arm17.5
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm9.22

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4M PFS Rate of Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma (MPM) Treated With CBP501, Pemetrexed and Cisplatin

Planned: Forty-two patients were to be treated in Arm A. If ≥ 23 patients (>54%) were free of progression and death at 4 months, then the study regimen would be considered for further evaluation in this indication. (NCT00700336)
Timeframe: End of study

,
Interventionparticipants (Number)
4M PFS by Independent Image Review4M PFS by Site assess
Pemetrexed and Cisplatin913
Pemetrexed, Cisplatin, and CBP5012527

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Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)

If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level. (NCT00702299)
Timeframe: 18 months

Interventionmg/m2 (Number)
Receiving Treatment500

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Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose

If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the Maximum Tolerance Dose (MTD) would be determined to be the next lower dose level. (NCT00702299)
Timeframe: 18 months

Intervention% of participants (Number)
Receiving Treatment80.0

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Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed

Cmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration (NCT00702299)
Timeframe: 18 months

Interventionug/mL (Mean)
Pemetrexed Dose 500mg/m225.1
Pemetrexed Dose 750 mg/m239.3
Pemetrexed Dose 1,000mg/m238.7

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Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125

Progression was evaluated with posttreatment CT scans and measured changes in cancer antigen 125 levels 6 months after the initiation of the treatment regimen, or within one month after discontinuation of treatment if stopped early. Cancer antigen 125 response in evaluable patients (N=13) was analyzed using the modified Gynecologic Cancer Intergroup (GCIG) criteria. There was one evaluable patient by Response Evaluation Criteria in Solid Tumors(RECIST) criteria (NCT00702299)
Timeframe: 18 months

Intervention% of participants (Number)
Receiving Treatment78.6

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Overall Survival

(NCT00702299)
Timeframe: Average Length of follow-up 788 days

InterventionDays (Median)
Receiving Treatment680

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Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)

Toxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0 (NCT00702299)
Timeframe: 18 months

Interventionparticipants (Number)
Receiving Treatment2

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Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan

"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Complete responsePartial response
Induction Chemo + RT + Cisplatin or Cetuximab917

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Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT

In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

,,
Interventionpercentage of participants (Number)
Complete ResponsePartial ResponseStable Disease/Progressive Disease
Clinical Examination61390
CT Scan304822
FDG-PET/CT36568

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Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT

In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

,,
Interventionpercentage of participants (Number)
Complete ResponsePartial ResponseStable Disease/Progressive Disease
Clinical Examination43570
CT Scan145036
FDG-PET/CT246610

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Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy

SPARC expression = intensity of SPARC staining in tumor (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Negative staining1+ staining (weak)2+ staining (moderate)3+ staining (strong)
Induction Chemo + RT + Cisplatin or Cetuximab6241

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Disease Free Survival

Time from complete response to death from any cause, to disease progression or to last follow-up alive. (NCT00736944)
Timeframe: 10 years from completion of treatment

Interventionmonths (Mean)
Induction Chemo + RT + Cisplatin or Cetuximab93.529

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Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT

"In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests.~We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

,,
Interventionpercentage of participants (Number)
Complete ResponsePartial ResponseStable Disease/Progressive Disease
Clinical Examination53470
CT Scan334126
FDG-PET/CT32617

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Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria

"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Complete responsePartial response
Induction Chemo + RT + Cisplatin or Cetuximab1011

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Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy

SPARC expression = intensity of SPARC staining in tumor (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Negative staining1+ staining (weak)2+ staining (moderate)3+ staining (strong)
Induction Chemo + RT + Cisplatin or Cetuximab14010

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Clinical Partial Response Rate at the Primary Tumor

"Clinical exam included laryngoscopy in office or operating room.~Partial response rate (PR) defined as 50% to 94% decrease in tumor size." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Induction Chemo + RT + Cisplatin or Cetuximab14

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Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria

"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Overall complete responseOverall partial response
Induction Chemo + RT + Cisplatin or Cetuximab414

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Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy

SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Negative staining1+ staining (0%-24%)2+ staining (25%-49%)3+ staining (50%-74%)4+ staining (75%-100%)
Induction Chemo + RT + Cisplatin or Cetuximab140100

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Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria

"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Complete responsePartial response
Induction Chemo + RT + Cisplatin or Cetuximab712

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Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy

SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Negative staining1+ staining (0%-24%)2+ staining (25%-49%)3+ staining (50%-74%)4+ staining (75%-100%)
Induction Chemo + RT + Cisplatin or Cetuximab64120

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Clinical Complete Response Rate at the Primary Tumor

"Clinical exam included laryngoscopy in office or operating room.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size." (NCT00736944)
Timeframe: post-2 cycles of induction (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Induction Chemo + RT + Cisplatin or Cetuximab16

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Overall Complete and Partial Response Rates by FDG Uptake on PET Scan

"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Overall complete responseOverall partial response
Induction Chemo + RT + Cisplatin or Cetuximab719

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Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan

"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Complete responsePartial response
Induction Chemo + RT + Cisplatin or Cetuximab914

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Clinical Overall Complete and Partial Response Rates

"Clinical exam included laryngoscopy in office or operating room.~Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days)

Interventionparticipants (Number)
Overall complete responseOverall partial response
Induction Chemo + RT + Cisplatin or Cetuximab1317

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Clinical Complete and Partial Response Rates to the Involved Regional Nodes

"Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size." (NCT00736944)
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)

Interventionparticipants (Number)
Complete responsePartial response
Induction Chemo + RT + Cisplatin or Cetuximab117

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Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis

(NCT00736944)
Timeframe: completion of the first 10 patients induction chemotherapy

Interventionparticipants (Number)
Allergic reaction/hypersensitivityOther allergic reaction:ciproOther allergic reaction:hivesHypotensionINRFatigueAlopeciaChelitisDry skinRashRash:acneiformRash:penile (unconfirmed HSV)AnorexiaColitisConstipationDehydrationDental:teethDiarrheaHemorrhoidsNauseaTaste alterationVomitingOther:soft stoolsHemoglobinLeukocytes (WBC)LymphopeniaNeutrophils (ANC)PlateletsHemmorrhage:noseAlkaline phosphataseSGPT (ALT)Infection other:sinus infectionEdema:limbAlbumin, lowCalcium, lowMagnesium, lowPotassium, lowPotassium, highSodium, lowPhosphorusDizzinessMood alteration:angerNeuropathy:sensory (peripheral)Vision-photophobiaPain:thighPain:tumor painHiccoughs (hiccups)Obstruction/stenosis of airway:tracheaCreatinineGFRRenal failureThrombosis/thrombus/embolism
Induction Chemo + RT + Cisplatin or Cetuximab11111105111711211111911188882132121543231111111124211

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Time to Progression

Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive. (NCT00736944)
Timeframe: 10 years from completion of treatment

Interventionmonths (Mean)
Induction Chemo + RT + Cisplatin or Cetuximab38.675

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Overall Survival

Time from diagnosis to death or to last follow-up alive. (NCT00736944)
Timeframe: 10 years from completion of treatment

Interventionmonths (Mean)
Induction Chemo + RT + Cisplatin or Cetuximab83.960

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Limiting Toxicity

"The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor." (NCT00742924)
Timeframe: Enrollment through the first 12 weeks of therapy.

Interventionparticipants (Number)
Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid1
Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid1
Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid3
Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD2

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Overall Survival

(NCT00770874)
Timeframe: From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months

Interventionmonths (Median)
S-1 + Cisplatin (Arm A)21.9
Cisplatin (Arm B)19.5

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Progression Free Survival, Safety

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00770874)
Timeframe: About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment

Interventionmonths (Median)
S-1 + Cisplatin (Arm A)7.3
Cisplatin (Arm B)4.9

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Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events

Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. All adverse events are counted, regardless of reported relationship to protocol treatment. (NCT00777491)
Timeframe: From start of treatment to 180 days after the end of treatment. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.

,
InterventionParticipants (Count of Participants)
During TreatmentBetween End of Treatment and 180 days after
5-FU and Cisplatin + BID Irradiation198
Gemcitabine + QD Irradiation185

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Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy

Patients will be considered as having a clinical complete response when all biopsies are negative at the site(s) of the pretreatment tumor(s). (NCT00777491)
Timeframe: 3-4 weeks following induction therapy (approximately maximum 8 weeks from start of treatment depending on treatment arm and allowed time windows)

InterventionParticipants (Count of Participants)
5-FU and Cisplatin + BID Irradiation29
Gemcitabine + QD Irradiation25

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Number of Participants With Progression or Removal of Bladder Five Years After Therapy

Progression is defined as an increase of 50% or more in the largest diameter of the endoscopically appreciable tumor in the tumor-site biopsy specimen, the development of new bladder tumors, or the development of metastatic disease. (NCT00777491)
Timeframe: From start of treatment to five years after the end of therapy. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.

InterventionParticipants (Count of Participants)
5-FU and Cisplatin + BID Irradiation4
Gemcitabine + QD Irradiation5

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Percentage of Patients Without Distant Metastases by Three Years

Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone. (NCT00777491)
Timeframe: From randomization to three years

Interventionpercentage of participants (Number)
5-FU and Cisplatin + BID Irradiation77.8
Gemcitabine + QD Irradiation84.0

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Change in American Urological Association Symptom Index (AUASI) Score at 3 Years

The AUASI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as 3-year score - baseline score such that a negative change indicates improvement. (NCT00777491)
Timeframe: Baseline and 3 years

,
Interventionunits on a scale (Median)
Sensation of Not Emptying BladderUrinate Again < 2 Hours After UrinatingStopped and Started When UrinatingDifficult to Postpone UrinationWeak Urinary StreamPush or Strain to Begin UrinationHow Often Get Up at Night to UrinateAUA Total Symptom Score
5-FU and Cisplatin + BID Irradiation-0.50-2.50-1.00-3.00-0.50-0.50-3.50-9.50
Gemcitabine + QD Irradiation0.0-1.00.00-0.500.000.00-1.50-3.50

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Percentage of Patients Who Completed Treatment Per Protocol

Treatment administration data was centrally reviewed to determine if patients completed each treatment component per protocol. (NCT00777491)
Timeframe: After each treatment component (induction, consolidation, adjuvant). Timing varies bases on arm, tumor response at multiple time points, and allowed time ranges.

,
InterventionParticipants (Count of Participants)
Induction TherapyConsolidation TherapyAdjuvant Therapy
5-FU and Cisplatin + BID Irradiation322718
Gemcitabine + QD Irradiation312317

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Probability of 2-year Overall Survival

(NCT00798655)
Timeframe: Up to 90 months for cohort; individual patients up to 24 months

Interventionpercentage of participants (Number)
Radiation Therapy+Cisplatin+Panitumumab72

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Probability of Progression-free Survival (PFS) at 2 Years

(NCT00798655)
Timeframe: Up to 90 months for cohort; individual patients up to 24 months after study treatment

Interventionpercentage of participants (Number)
Radiation Therapy+Cisplatin+Panitumumab70

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To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.

The number of patients on each arm who have Grade 3 AE or higher toxicity. (NCT00803062)
Timeframe: From date of enrollment until 30 days after treatment completion

,,,
InterventionParticipants (Count of Participants)
LeukopeniaThrombocytopeniaNeutropeniaAnemiaOther hematologicAllergy/ImmunologyAuditory/EarCardiacCoagulationConstitutionalDermatologicEndocrineGastrointestinalGenitourinary/RenalHemorrhageHepatobiliaryInfectionLymphaticsMetabolicMusculoskeletalNeuropathyOther NeurologicalPainPulmonaryVascularDeath, Not CTC coded
Arm I (Paclitaxel and Cisplatin)34648333412412022210401731809821381
Arm II (Paclitaxel, Cisplatin, Bevacizumab)4856129841164160029870181232125309172
Arm III (Topotecan Hydrochloride and Paclitaxel)4856123610411301117501911122722562
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)669793062014016412214913011723927472

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Progression-free Survival

"Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate." (NCT00803062)
Timeframe: From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)

Interventionmonths (Median)
Arm I (Paclitaxel and Cisplatin)6.67
Arm II (Paclitaxel, Cisplatin, Bevacizumab)9.63
Arm III (Topotecan Hydrochloride and Paclitaxel)5.29
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)7.36

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Overall Survival

The observed length of life from randomization into the study to death or the date of last contact. (NCT00803062)
Timeframe: From entry into the study to death or the date of last contact, assessed up to 5 years

Interventionmonths (Median)
Arm I (Paclitaxel and Cisplatin)14.26
Arm II (Paclitaxel, Cisplatin, Bevacizumab)17.51
Arm III (Topotecan Hydrochloride and Paclitaxel)12.68
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)16.20

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Tumor Response

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR. (NCT00803062)
Timeframe: Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.

Interventionpercentage of participants (Number)
Arm I (Paclitaxel and Cisplatin)44.74
Arm II (Paclitaxel, Cisplatin, Bevacizumab)49.57
Arm III (Topotecan Hydrochloride and Paclitaxel)27.03
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)47.32

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Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)

Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) & all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of >=1 NTL (NonCR/NonPD) + no NWL; OR >=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):>=20% increase in sum of LD of TL regardless of NTL & NWL status; or unequivocal progression of NTL regardless of TL & NWL status; or NWL regardless of TL & NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL. (NCT00832117)
Timeframe: At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.

,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseDisease ProgressionNot Assessed
32mg/m^2+Cis 80mg/m^200221
Ixa 32 mg/m^2+Cis 60 mg/m^2081051

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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria

AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. (NCT00832117)
Timeframe: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.

,
Interventionparticipants (Number)
DeathSAEsDrug-Related SAEsAEs Leading to DiscontinuationDrug-Related AEs Leading to DiscontinuationOverall AEsGrade 3/4 AEsDrug-Related AEsGrade 3/4 Drug-Related AEs
32mg/m^2+Cis 80mg/m^2121005353
Ixa 32 mg/m^2+Cis 60 mg/m^24742124142411

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Participants Experiencing Dose Limiting Toxicity (DLT)

DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for >3 weeks;Gr4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever >38.5°C;thrombocytopenia <25,000 cells/mm^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7. (NCT00832117)
Timeframe: Within the first 21 days of first cycle

Interventionparticipants (Number)
Ixa 32 mg/m^2+Cis 60 mg/m^20
32mg/m^2+Cis 80mg/m^22

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Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria

Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 NCT00832117)
Timeframe: Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.

,
Interventionparticipants (Number)
WBC, Grade 1-4WBC, Grade 3-4ANC, Grade 1-4ANC, Grade 3-4Platelet Count, Grade 1-4Platelet Count, Grade 3-4Hemoglobin, Grade 1-4Hemoglobin, Grade 3-4
32mg/m^2+Cis 80mg/m^253543150
Ixa 32 mg/m^2+Cis 60 mg/m^2196181290221

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Randomized Part: Progression Free Survival (PFS) Time - Independent Read

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy6.2
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cetuximab + Chemotherapy5.0

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Randomized Part: Overall Survival (OS) Time

The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. (NCT00842712)
Timeframe: Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy13.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy13.6
Randomized Part: Cetuximab + Chemotherapy9.7

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Randomized Part: Best Overall Response (BOR) Rate

The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions. (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionpercentage of participants (Number)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy37.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy27.5
Randomized Part: Cetuximab + Chemotherapy29.8

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Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)

(NCT00842712)
Timeframe: Up to Week 3

Interventionparticipants (Number)
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem0
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin0
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem0
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin0

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Randomized Part: Time to Treatment Failure

Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC). (NCT00842712)
Timeframe: Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy4.4
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy2.8
Randomized Part: Cetuximab + Chemotherapy4.2

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Randomized Part: Progression Free Survival (PFS) Time - Investigator Read

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cetuximab + Chemotherapy5.3

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MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B

The Maximum Tolerated Dose (MTD) for Dasatinib was defined as a) the dose producing DLT ( Dose limiting toxicity) in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 150mg PO QD with less than 33% rate of DLT. (NCT00882583)
Timeframe: Last day of Radiation

,
InterventionParticipants (Count of Participants)
Dose 70 mgDose 100mgDose 150mg
Cohort A430
Cohort B732

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Progression-free Survival (PFS)

Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. (NCT00887159)
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

Interventionmonths (Median)
Arm A (CE)4.4
Arm B (CE+GDC-0449)4.4
Arm C (CE+IMC-A12)4.6

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PFS

Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs). (NCT00887159)
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

Interventionmonths (Median)
High CTC Count4.1
Low CTC Count4.5

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Response Rate

Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s). (NCT00887159)
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

InterventionProportion of patients (Number)
Arm A (CE)0.48
Arm B (CE+GDC-0449)0.56
Arm C (CE+IMC-A12)0.50

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Overall Survival (OS)

Overall survival is defined as the time from randomization to death or date of last known alive. (NCT00887159)
Timeframe: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

Interventionmonths (Median)
Arm A (CE)8.8
Arm B (CE+GDC-0449)9.8
Arm C (CE+IMC-A12)10.1

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Overall Response (OR) Rate

Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT00911820)
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.

Interventionproportion of patients (Number)
Arm A: PCA.568
Arm B: TPCA.512

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Progression-Free Survival

Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. (NCT00911820)
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis.

Interventionmonths (Median)
Arm A: PCA7.9
Arm B: TPCA8.4

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Best Response

Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria. (NCT00911820)
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis..

,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseRemoved Before Restaging
Arm A: PCA3221513
Arm B: TPCA0211406

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Overall Survival

Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods. (NCT00911820)
Timeframe: Patients in the study cohort were followed up to approximately 2.5 years as of this analysis.

Interventionmonths (Median)
Arm A: PCA11.7
Arm B: TPCA13.4

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7-month Progression-Free Survival

7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. (NCT00911820)
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.

Interventionprobability (Number)
Arm A: PCA0.581
Arm B: TPCA0.582

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Overall Survival (OS)

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS. (NCT00942331)
Timeframe: From date of randomization to date of death due to any cause, assessed up to 7 years

Interventionmonths (Median)
Arm II (GCB)14.5
Arm I (GCP)14.3

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Number of Patients Experiencing Grade 3+ Toxicity

The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below. (NCT00942331)
Timeframe: Up to 7 years

InterventionParticipants (Count of Participants)
Arm II (GCB)183
Arm I (GCP)163

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Objective Response

"Objective response is defined as confirmed complete and partial responses using Response Evaluation Criteria in Solid Tumors criteria. A complete response (CR) is defined as a disappearance of all target lesions. A partial response (PR) is defined as having at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum.~In each arm, the number of patients reporting a CR or PR was divided by the number of patients evaluable in each arm to obtain the proportion." (NCT00942331)
Timeframe: Up to 7 years

Interventionproportion of participants (Number)
Arm II (GCB)0.4
Arm I (GCP)0.36

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Progression-free Survival (PFS)

The primary analysis of PFS will be a two-sided stratified log-rank test comparing arm A and arm B. The stratification factors will consist of the two stratification factors used for patient randomization: prior nephrectomy (yes vs. no) and Motzer score (0 vs. 1-2 vs. 3+). Results from unstratified log-rank tests will also be provided. Kaplan-Meier methodology will be used to estimate median PFS for each treatment arm. (NCT00942331)
Timeframe: From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years

Interventionmonths (Median)
Arm II (GCB)8.0
Arm I (GCP)6.7

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Patient-reported Peripheral Neuropathy Symptoms

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms. (NCT00942357)
Timeframe: Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment

,
Interventionunit on a scale (Least Squares Mean)
Baseline6 weeks18 weeks70 weeks
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)14.914.410.411.8
Arm II (Paclitaxel and Carboplatin)15.012.49.911.6

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Patient-reported Quality of Life (QOL)

Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL. (NCT00942357)
Timeframe: Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment

,
Interventionunits on a scale (Least Squares Mean)
Baseline6 weeks18 weeks70 weeks
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)98.489.587.896.0
Arm II (Paclitaxel and Carboplatin)97.690.993.099.4

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Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0

The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death. (NCT00942357)
Timeframe: Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4Grade 5
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)5139154480
Arm II (Paclitaxel and Carboplatin)151181191053

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Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0

The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death. (NCT00942357)
Timeframe: Assessed every 6 months for 3 years

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4Grade 5
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)857145141
Arm II (Paclitaxel and Carboplatin)96793374

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Number of Participants With Recurrence, Progression or Death

Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions. (NCT00942357)
Timeframe: Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.

Interventionparticipants (Number)
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)132
Arm II (Paclitaxel and Carboplatin)139

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The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.

(NCT00942825)
Timeframe: 15 June 2009 to 30 September 2012

Interventiondays (Median)
A CBP501 +Cisplatin + Pemetrexed140
B Cisplatin + Pemetrexed165

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Patient Reported Neurotoxicity (Ntx)

The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL. (NCT00951496)
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment

,,
InterventionUnits on a scale (Least Squares Mean)
BaselinePrior to cycle 4Prior to cycle 7Prior to cycle 13Prior to cycle 2184 weeks
Arm I (Paclitaxel, Carboplatin, Bevacizumab)15.412.910.411.111.411.9
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)15.413.010.310.511.111.4
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)15.413.610.99.211.011.5

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Median Progression-free Survival

Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00951496)
Timeframe: Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.

Interventionmonths (Median)
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)24.9
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)27.3
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)26.0

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Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0

Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event. (NCT00951496)
Timeframe: During treatment and up to 30 days after end of treatment

,,
InterventionParticipants (Count of Participants)
Adverse Event Grade 0Adverse Event Grade 1Adverse Event Grade 2Adverse Event Grade 3Adverse Event Grade 4Adverse Event Grade 5
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)01482691858
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)00463001586
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)105224619910

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Patient Reported Quality of Life (QOL)

QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL). (NCT00951496)
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment

,,
InterventionUnits on a scale (Least Squares Mean)
BaselinePrior to cycle 4Prior to cycle 7Prior to cycle 13Prior to cycle 2184 weeks
Arm I (Paclitaxel, Carboplatin, Bevacizumab)68.567.869.177.377.778.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)67.465.668.277.176.977.7
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)67.761.965.778.478.279.4

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Overall Survival

Estimate the median duration of overall survival in months. (NCT00951496)
Timeframe: Up to 10 years

InterventionMonths (Median)
Arm I (Paclitaxel, Carboplatin, Bevacizumab)75.4
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)74.2
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)67.6

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Patient Reported Fatigue

Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue. (NCT00951496)
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment

,,
Interventionunits on a scale (Least Squares Mean)
BaselinePrior to cycle 4Prior to cycle 7Prior to cycle 13Prior to cycle 2184 weeks
Arm I (Paclitaxel, Carboplatin, Bevacizumab)35.332.532.735.735.535.7
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)35.132.032.735.535.136.0
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)35.331.332.435.936.336.5

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Patient Reported Nausea

Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much) (NCT00951496)
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment

,,
Interventionunits on a scale (Least Squares Mean)
BaselinePrior to cycle 4Prior to cycle 7Prior to cycle 13Prior to cycle 2184 Weeks
Arm I (Paclitaxel, Carboplatin, Bevacizumab)0.40.60.50.20.30.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)0.40.70.50.30.40.4
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)0.41.10.70.20.30.3

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Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)

RECIST version 1.1 was utilized for this outcome measure. A detailed description of RECIST 1.1 can be found here: Nishino M, Jackman DM, Hatabu H, Yeap BY, Cioffredi LA, Yap JT, et al. New Response Evaluation Criteria in Solid Tumors (RECIST) guidelines for advanced non-small cell lung cancer: comparison with original RECIST and impact on assessment of tumor response to targeted therapy. AJR Am J Roentgenol 2010;195:W221-8. (NCT00963807)
Timeframe: Up to 6 weeks

Interventionpercentage of participants (Number)
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)33

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Change in FLT Uptake in Responders and Non-responders

Unadjusted analysis will be performed utilizing students t-tests. If the data appears non-normal, the Wilcox on rank-sum test will be used rather than the t-test. Adjusted analysis will be performed utilizing logistic regression. (NCT00963807)
Timeframe: Baseline and 6 weeks

InterventionSULmax (Mean)
Responders-1.8
Non-Responders1.2

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Change in FLT Uptake

Will be calculated by subtracting the uptake of the scan after the second cycle of chemotherapy from the uptake of the pre-treatment scan. (NCT00963807)
Timeframe: Baseline and 6 weeks

InterventionSULmax (Mean)
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)0.2

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Change in 18F-Fluorothymidine (FLT) Uptake

Will be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.. Change in FLT uptake will be measured using the maximum standard uptake value adjusted for lean body mass (SULmax), which is a measure of how much radiotracer (in this case FLT) is being consumed by cells. (NCT00963807)
Timeframe: Baseline and 3 weeks

InterventionSULmax (Mean)
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)-0.4

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Change in 18F-Fluorodeoxyglucose (FDG) Uptake

Will be calculated by subtracting the baseline FDG uptake from the post-cycle 2 uptake (as measured by SULmax). (NCT00963807)
Timeframe: Baseline and 6 weeks

InterventionSULmax (Mean)
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)-3.8

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Overall Survival

(NCT00968799)
Timeframe: 5 years

Interventionmonths (Median)
HIPEC26

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Fitness for Systemic Chemotherapy

"Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial.~If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit.~If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit." (NCT00968799)
Timeframe: 3 months post operation

Interventionparticipants (Number)
HIPEC4

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Nephrotoxicity

glomerular filtration rate (GFR) (NCT00968799)
Timeframe: 6 weeks post operation

Interventionparticipants (Number)
no nephrotoxicity (normal GFR)CTCAE grade 1 nephrotoxicity (by GFR)
HIPEC22

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Surgical Complications

any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3) (NCT00968799)
Timeframe: 6 weeks post operation

Interventionparticipants (Number)
HIPEC0

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. (NCT00977561)
Timeframe: Baseline up to follow-up (90 days post dose)

,
Interventionparticipants (Number)
Adverse EventsSerious Adverse Events
Cisplatin or Carboplatin + Etoposide42
Figitumumab + Cisplatin or Carboplatin + Etoposide54

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Event-free Survival

Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT00980460)
Timeframe: Time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 5 years

InterventionPercent Probability (Number)
Very Low-risk Group100
Low-risk Group (Regimen T)87.21
Intermediate-risk Group (Regimen F)87.03
High-risk Group (Regimen W)43.61
High-risk Group (Regimen H)46.38

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Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed

All grade 3 or 4 or greater non-hematological toxicities. The frequency of each toxicity type will be quantified as the number of reporting periods on which the toxicity of the relevant grade is reported. This measure does not apply to patients enrolled in the VERY LOW RISK group. (NCT00980460)
Timeframe: During protocol therapy up to 1 year after enrollment

,,,
InterventionCycles (Number)
Hearing impairedDiarrheaEnterocolitisNauseaSmall intestinal obstructionVomitingAbdominal distensionAbdominal painColitisAnal mucositisAscitesMalabsorptionMucositis oralConstipationDental cariesTyphlitisDuodenal obstructionEsophageal hemorrhageGastritisIlleusOral painSmall intestinal mucositisColonic hemorrhageDysphagiaEsophagitisGastroparesisGastric fistulaGastrointestinal disorders - Other, specifyObstruction gastricRectal mucositisFeverGeneral disorders and administration site conditions - Other, specifyPainMulti-organ failureIrritabilityInfusion related reactionHypothermiaCatheter related infectionInfections and infestations - Other, specifyMucosal infectionOtitis mediaUrinary tract infectionBiliary tract infectionAbdominal infectionBladder infectionEnterocolitis infectiousDuodenal infectionUpper respiratory infectionEye infectionWound infectionSepsisLung infectionPeritoneal infectionSkin infectionSmall intestine infectionPeriorbital infectionAlanine aminotransferase increasedAspartate aminotransferase increasedActivated partial thromboplastin time prolongedAlkaline phosphatase increasedBlood bilirubin increasedCreatinine increasedGGT increasedWeight lossFibronogen decreasedEjection fraction decreasedInvestigations - Other, specifyWhite blood cell decreasedINR increasedCPK increasedCholesterol highElectrocardiogram QT corrected interval prolongedLipase increasedSerum amylase increasedAnorexiaDehydrationHyperglycemiaHyperkalemiaHypermagnesemiaHypernatremiaHypokalemiaHyponatremiaAcidosisAlkalosisHypocalcemiaHypoalbuminemiaHypomagnesemiaHypophosphatemiaTumor lysis syndromeHypercalcemiaHypoglycemiaHypertriglyceridemiaMetabolism and nutrition disorders - Other, specifyPeripheral sensory neuropathyOculomotor nerve disorderAbducens nerve disorderPeripheral motor neuropathySyncopeDysphasiaDepressed level of consciousnessSeizureApneaAtelectasisDyspneaBronchospasmHypoxiaPleural effusionPulmonary edemaStridorRespiratory failureEpistaxisWheezingHypertensionHematomaHypotensionVascular disorders - Other, specifyThromboembolic eventLeft ventricular systolic dysfunctionCardiac arrestRight ventricular dysfunctionVentricular tachycardiaCardiac disorders - Other, specifySinus tachycardiaHeart failureMyocardial infarctionBiliary fistulaHepatobiliary disorders - Other, specifyHepatic hemorrhagePortal vein thrombosisPortal hypertensionBiliary anastomotic leakPostoperative hemorrhageGastrointestinal anastomotic leakIntraoperative hemorrhageArthralgiaGeneralized muscle weaknessBack painBone painMuscle weakness lower limbAgitationHallucinationsInsomniaAcute kidney injuryRenal and urinary disorders - Other, specifyRenal calculiProteinuriaErythema multiformeSkin and subcutaneous tissue disorders - Other, specifyRash maculo-papularEye disorders - Other, specifySurgical and medical procedures - Other, specifyTumor painAllergic reactionAnaphylaxisImmune system disorders - Other, specify
High-risk Group (Regimen H)4151305061000600100000000001111904211109003000502003107016191151661100011111171210503291013212190014110020011003061001114050100000410011000001000000010001012000221
High-risk Group (Regimen W)415010013391000810200141011110000101000012711000040200000100910302014000110000020353001260043370110020230100001022000202131113001111001011120000001000100001001000
Intermediate-risk Group (Regimen F)20150101241103111442121113410000000091610008380031128141152111028372173762110000000301315124148224173112120000531710000221102112006132011210000112101100121114109310123110000
Low-risk Group (Regimen T)14111200000000000000000000000010000001411100000000000000110000000000000000132222410000000000020000000100000000003000000000000000000000000000000000000000000

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Disease Status at the End of 2 Courses of Therapy

RECIST v 1.1 and serum alphafetoprotein responses are evaluated separately. RECIST v 1.1 complete response (CR) is defined as disappearance of all target lesions and partial response (PR) is defined as reduction of at last 30% in the sum of the longest dimension of all target lesions (CR and PR measured by CT or MRI) between enrollment. Serum alphafetoprotein response is a decrease of at least 90% from the last serum alphafetoprotein measurement from the baseline prior to the start of chemotherapy to the end of cycle 2. This is calculated for HIGH RISK regimen W and HIGH RISK regimen H only. (NCT00980460)
Timeframe: First two cycles of therapy- up to 42 days after enrollment

,
Interventionparticipants (Number)
RECIST PR, no AFP responseAFP response, no RECIST responseRECIST response, AFP responseno AFP response, no RECIST response
High-risk Group (Regimen H)310418
High-risk Group (Regimen W)35616

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Number of Deaths

Number of patients who experience on-protocol-therapy death possibly, probably or likely related to systemic chemotherapy. This outcome measure applies to INTERMEDIATE RISK patients only. (NCT00980460)
Timeframe: During protocol therapy or within 30 days of the termination of protocol therapy up to 1 year after enrollment

InterventionParticipants (Count of Participants)
Intermediate-risk Group (Regimen F)1

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Feasibility of Referral for Liver Transplantation

A patient for whom referral is considered appropriate who receives a consultation after enrollment will be considered a success with respect to feasibility. (NCT00980460)
Timeframe: 3 cycles of therapy - up to 3 months after enrollment

InterventionParticipants (Count of Participants)
Intermediate-risk Group (Regimen F)37
High-risk Group (Regimen H)16

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Response Rates Confirmed With CT or MRI

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0." (NCT00995761)
Timeframe: after every 2 cycles of docetaxel and cisplatin

Interventionpercentage of participants (Number)
Biweekly Schedule of Docetaxel and Cisplatin64.6

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Overall Survival (OS)

Overall survival (OS) is defined as time from randomization to death from any cause, censoring cases who had not died at the date last known alive. (NCT01004978)
Timeframe: Assessed every 3 months for 2 years and then every 6 months for 2 years

Interventionmonths (Median)
Arm A (Sorafenib and TACE)19.8
Arm B (Placebo and TACE)19.9

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Progression-free Survival (PFS)

"PFS is defined to be the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up will be censored at the date of last disease assessment without progression, unless death occurs within 4 months following the date last known progression-free, in which case the death will be counted as an event.~Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions." (NCT01004978)
Timeframe: Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years

Interventionmonths (Median)
Arm A (Sorafenib and TACE)9.3
Arm B (Placebo and TACE)8.4

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Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression

"PFS is defined to be the time from randomization to progression or death without evidence of progression.~Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.~For patients with progressive disease, the progression was classified as either intra- or extra-hepatic or both intra- and extra-hepatic. Patients with both intra- and extra-hepatic progression were considered as having extra-hepatic progression. This analysis was performed among patients with extra-hepatic progression." (NCT01004978)
Timeframe: Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years

Interventionmonths (Median)
Arm A (Sorafenib and TACE)6.83
Arm B (Placebo and TACE)5.6

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Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression

"PFS is defined to be the time from randomization to progression or death without evidence of progression.~Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.~For patients with progressive disease, the progression was classified as either intra- or extra-hepatic or both intra- and extra-hepatic. This analysis was performed among patients with intra-hepatic progression." (NCT01004978)
Timeframe: Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years

Interventionmonths (Median)
Arm A (Sorafenib and TACE)8.5
Arm B (Placebo and TACE)7.8

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Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start

Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events reported as definitely, probably, or possibly related to study treatment. (NCT01005329)
Timeframe: From start of treatment to one year

Interventionpercentage of participants (Number)
Chemoradiation (IMRT), Chemotherapy43.3

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Pelvic Failure Rate (Two-year Rate Reported)

Pelvic failure (PF) was defined as disease recurrence in the pelvis, including the pelvic or sacral lymph nodes, and required confirmation by histologic or cytologic biopsy of the recurrent lesion. Death was considered a competing risk. PF rates were estimated using the cumulative incidence method. (NCT01005329)
Timeframe: From registration to two years

Interventionpercentage of participants (Number)
Chemoradiation (IMRT), Chemotherapy0

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Overall Survival (Two-year Rate Reported)

Failure was defined as death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Survival rate at two years was estimated using the Kaplan-Meier method. (NCT01005329)
Timeframe: From registration to two years

Interventionpercentage of participants (Number)
Chemoradiation (IMRT), Chemotherapy96.7

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Distant Failure (Two-year Rate Reported)

Distant Failure (DF) was defined as the appearance of distant metastasis. Death was considered a competing risk. DF rates were estimated using the cumulative incidence method. (NCT01005329)
Timeframe: From registration to two years

Interventionpercentage of participants (Median)
Chemoradiation (IMRT), Chemotherapy17.0

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Disease-free Survival (Two-year Rate Reported)

Failure was defined as pelvic failure (recurrence in the pelvis, which must be confirmed by histologic or cytologic biopsy of the recurrent lesion), distant failure (confirmed by histologic or cytologic biopsy of the recurrent lesion), or death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Disease-free survival rate at two years was estimated using the Kaplan-Meier method. (NCT01005329)
Timeframe: From registration to two years

Interventionpercentage of participants (Number)
Chemoradiation (IMRT), Chemotherapy79.1

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Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start

Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. (NCT01005329)
Timeframe: From start of treatment to 90 days

Interventionpercentage of participants (Number)
Chemoradiation (IMRT), Chemotherapy23.3

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Maximum Tolerated Dose (MTD) of RAD001 in Combination With Cetuximab and Cisplatin.

MTD will be defined as a) the dose of RAD001 producing DLT in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 10mg po qd with less than 33% rate of DLT (NCT01009346)
Timeframe: 6 months

Interventionmg (Number)
Study Arm (RAD001, Cetuximab, Cisplatin or Carboplatin)10

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Progression Free Survival (PFS) of RAD001 in Combination With Weekly Cetuximab and Cisplatin.

Median number of months for which participants are free of progression after initiating treatment with RAD001 in combination with weekly cetuximab and cisplatin. (NCT01009346)
Timeframe: 2 years

Interventionmonths (Median)
Study Arm (RAD001)2.8

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Overall Survival (OS)

The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported. (NCT01042522)
Timeframe: From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.

InterventionParticipants (Count of Participants)
Arm I (Paclitaxel, Carboplatin)5
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)8

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Progression-free Survival (PFS)

The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT01042522)
Timeframe: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.

Interventionmonths (Median)
Arm I (Paclitaxel, Carboplatin)27.7
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)19.7

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Tumor Response Rate

"Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR)." (NCT01042522)
Timeframe: Median followup time was 48 months.

Interventionproportion of participants (Number)
Arm I (Paclitaxel, Carboplatin)0.43
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)0.54

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Number of Participants With Dose Limiting Toxicities (DLTs)

DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity preventing treatment for ≥3 weeks or preventing administration of ≥8 of 10 doses in Parts 1 or 2A1 or 4 of 5 doses in Part 2A2. (NCT01047007)
Timeframe: Cycle 1 (21 days)

InterventionParticipants (Number)
Part 1: MK-1775 65 mg BID0
Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg1
Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg1

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Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period

InterventionMonths (Median)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNA
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA

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Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

InterventionMonths (Median)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin14.36
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin6.14

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Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

InterventionMonths (Median)
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin16.36
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin10.12

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Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2

DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

InterventionParticipants (Count of Participants)
Cohort 1, Arm 20
Cohort 2a, Arm 22
Cohort 2b, Arm 21
Cohort 3b, Arm 22
Cohort 4, Arm 20
MTD Confirmation Cohort, Arm 23

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Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1

DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

InterventionParticipants (Count of Participants)
Cohort 1, Arm 10
Cohort 2, Arm 10
Cohort 3, Arm 11
Cohort 4, Arm 12
MTD Confirmation Cohort, Arm 12

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Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

InterventionPercentage of participants (Number)
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin81.3
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin51.9

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Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy

"The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

InterventionPercentage of Participants (Number)
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin21.3
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin36.4

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Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy

"The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

InterventionPercentage of Participants (Number)
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin91.7
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin96.4

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Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

InterventionPercentage of participants (Number)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin81.3
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin53.6

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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts

Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12 and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin80.0066.6722.22
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin60.9847.9233.54

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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.

Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12, and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin61.8551.5444.67
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin54.7424.88NA

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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin100.0080.0080.00
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin74.0762.9655.09

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Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period

InterventionMonths (Median)
DE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNA
DE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA

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Percentage of Participants With a Treatment Emergent AE

An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0). (NCT01055496)
Timeframe: SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.

,
InterventionPercentage of Participants (Number)
Subjects with AEsSubjects with SAEsSubjects with Grade 3 or 4 AEsSubjects with Grade 5 AEsSubjects discontinued due to AEsSubjects with dose reduced due to AEsSubjects with temporary discontinuation due to AEs
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin10031.389.64.227.116.754.2
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin10045.596.45.536.432.767.3

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Mean Inotuzumab Ozogamicin Serum Concentrations

Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.

,
Interventionng/mL (Mean)
Cycle 1 Day 2, 0hCycle 3 Day 2, 0hCycle 3 Day 2, 1hCycle 3 Day 2, 3hCycle 3 Day 3, 24hCycle 3 Day 8, 168h
Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA25.00283.27280.33154.25NA
Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNANA189.74213.95110.39NA

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Mean Inotuzumab Ozogamicin Serum Concentrations

Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.

,,,
Interventionng/mL (Mean)
Cycle 1 Day 2, 0h
Cohort 1, Arm 2NA
Cohort 3b, Arm 2NA
Cohort 4, Arm 1NA
Cohort 4, Arm 2NA

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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 Months

,
InterventionPercent Probability (Number)
6 months12 months24 months
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin84.3878.1371.61
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin88.0059.1153.74

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Disease Control (CR + PR + Stable Disease [SD])

Complete Response (CR) + Partial Response (PR) + Stable disease (NCT01064479)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)47
Arm B (Combination Chemotherapy and Placebo)41

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Overall Survival (OS)

Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals. (NCT01064479)
Timeframe: 5 years

Interventionmonths (Median)
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)16.95
Arm B (Combination Chemotherapy and Placebo)13.67

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Progression Free Survival (PFS)

Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals. (NCT01064479)
Timeframe: 5 years

Interventionmonths (Median)
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)6.08
Arm B (Combination Chemotherapy and Placebo)4.4

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Rash Rates

Participants with a Rash of at least grade 2 within cycle 1. (NCT01064479)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)20
Arm B (Combination Chemotherapy and Placebo)4

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Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions (NCT01064479)
Timeframe: 5 years

,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseProgressive DiseaseStable DiseaseInevaluable
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)4278165
Arm B (Combination Chemotherapy and Placebo)51913175

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Disease Control Rate by Modified RECIST (Phase II)

"Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA), does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA.~All target measurable lesions must be assessed using the same techniques as baseline." (NCT01064648)
Timeframe: Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control is documented for as long as the patient remains on protocol treatment.

Interventionpercentage of analyzed participants (Number)
Phase II Cisplatin-pemetrexed Cediranib 20mg75
Phase II Cisplatin-pemetrexed Placebo83

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Disease Control Rate by RECIST 1.1 (Phase II)

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA~All target measurable lesions must be assessed using the same techniques as baseline." (NCT01064648)
Timeframe: Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control rate is documented for as long as the patient remains on protocol treatment.

Interventionpercentage of analyzed participants (Number)
Phase II Cisplatin-pemetrexed Cediranib 20mg74
Phase II Cisplatin-pemetrexed Placebo80

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Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)

"MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to one of the 3 study drugs). The following events occurring in the first cycle of treatment are considered dose limiting.~Febrile neutropenia~Grade 4 neutrophil count decrease for more than 7 days' duration~Grade 4 platelet count decrease~Grade 3 or 4 non-hematologic toxicity (excluding alopecia)" (NCT01064648)
Timeframe: Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment.

Interventionmg (Number)
All Phase I Participants20

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Progression-free Survival (Phase II)

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesions, or the appearance of new lesions. (NCT01064648)
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression.

Interventionmonth (Median)
Phase II Cisplatin-pemetrexed Cediranib 20mg7.2
Phase II Cisplatin-pemetrexed Placebo5.6

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Response Rate by Modified RECIST (Phase II)

"Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~All target measurable lesions must be assessed using the same techniques as baseline." (NCT01064648)
Timeframe: Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Best response is documented for as long as the patient remains on protocol treatment.

Interventionpercentage of analyzed participants (Number)
Phase II Cisplatin-pemetrexed Cediranib 20mg50
Phase II Cisplatin-pemetrexed Placebo20

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Response Rate by RECIST1.1 (Phase II)

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~All target measurable lesions must be assessed using the same techniques as baseline." (NCT01064648)
Timeframe: Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years. Best response is documented for as long as the patient remains on protocol treatment.

Interventionpercentage of analyzed participants (Number)
Phase II Cisplatin-pemetrexed Cediranib 20mg26
Phase II Cisplatin-pemetrexed Placebo15

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Overall Survival (Phase II)

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT01064648)
Timeframe: From date of registration to death.Disease assessment will be repeated every 6 weeks until disease progression. After progression, follow up will occur every 6 months for the first two years and then at the end of the third year after registration.

Interventionmonth (Median)
Phase II Cisplatin-pemetrexed Cediranib 20mg10
Phase II Cisplatin-pemetrexed Placebo8.5

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6-month Progression-free Survival (6-mo PFS) Rate

6-month progression-free survival. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT01091454)
Timeframe: At 6 months

Interventionproportion of participants (Number)
Treatment (Cisplatin and Brostallicin)0.277

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3-month Progression-free Survival (3-mo PFS) Rate

A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT01091454)
Timeframe: 3 months

Interventionproportion of participants (Number)
Treatment (Cisplatin and Brostallicin)0.511

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Confirmed Response Rate

A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01091454)
Timeframe: Up to 5 years

Interventionpercentage of confirmed responses (Number)
Treatment (Cisplatin and Brostallicin)22

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Duration of Response

Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01091454)
Timeframe: Up to 5 years

Interventionmonths (Median)
Treatment (Cisplatin and Brostallicin)4

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Time to Disease Progression

Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT01091454)
Timeframe: up to 5 years

Interventionmonths (Median)
Treatment (Cisplatin and Brostallicin)3.2

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Survival Time

Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT01091454)
Timeframe: Up to 5 years

Interventionmonths (Number)
Treatment (Cisplatin and Brostallicin)8.3

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OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation

The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm I: Observation100

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OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only.

Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 190.7
Arm III: Randomized to Radiation Only in Stratum 186.4

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EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation

The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm I: Observation66.9

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EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 172.7
Arm III: Randomized to Radiation Only in Stratum 162.9

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EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy

The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm IV: Nonrandomly Assigned to Arm II Treatment33.6

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EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 241.7
Arm III: Randomized to Radiation Only in Stratum 267.5

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Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy69.2
Arm III: Randomized to Radiation Only63.7

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Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy88.3
Arm III: Randomized to Radiation Only86.9

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OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 269.2
Arm III: Randomized to Radiation Only in Stratum 289.5

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OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy

The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm IV: Nonrandomly Assigned to Arm II Treatment74.0

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Tumor Responses

Change in tumor size (sum of longest diameters of target lesions) after two cycles of induction therapy, expressed as log of ratio of post-treatment to baseline measure. (NCT01133678)
Timeframe: Baseline and 2 months

Interventiondimensionless (log ratio) (Mean)
Everolimus-0.609
Placebo-0.796

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Freedom From Local Progression at 12 Months

the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk (NCT01151761)
Timeframe: 12 months

Interventionpercentage of patients (Number)
SBRT and Chemo0

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Liver Transplant Conversion Rate

The ability to successfully perform liver transplant among patients who initially have tumor >3 cm (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Liver Transplant Rate

The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Median Time to Overall Survival

The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology. (NCT01151761)
Timeframe: 18 months

Interventionmonths (Median)
SBRT and Chemo8.5

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Overall Survival at 12 Months

the estimated probability for the percentage of participants with overall survival at 12 months. (NCT01151761)
Timeframe: 12 months

Interventionprobability (Number)
SBRT and Chemo0

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Pathologic Complete Response Rate

Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen. (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Progression-free Survival at 12 Months

Progression free survival is defined to be the time to progression of disease or death. (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Serum CA 19-9 Levels

Initial level of Cancer antigen 19-9 (NCT01151761)
Timeframe: 12 months

InterventionU/ml (Mean)
SBRT and Chemo3329.1

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Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy

Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%. (NCT01175356)
Timeframe: Up to day -6 of conditioning

InterventionPercentage of participants (Number)
Treatment (131I-MIBG, Chemotherapy)82.2

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Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG

Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory. (NCT01175356)
Timeframe: Up to 6 weeks after course 5 of induction

InterventionParticipants (Count of Participants)
Treatment (131I-MIBG, Chemotherapy)3

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Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131

Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%. (NCT01175356)
Timeframe: Up to 6 weeks after course 5 of induction

InterventionPercentage of participants (Number)
Treatment (131I-MIBG, Chemotherapy)86.8

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Progression Free Survival (PFS)

(NCT01194453)
Timeframe: 36months

Interventionday (Median)
Group A168
Group B140

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Response Rate

(NCT01194453)
Timeframe: 6 weeks

Interventionpercentage (Number)
Group A24.41
Group B14.17

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Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately. (NCT01194869)
Timeframe: At the time of surgery, after 24 weeks of preoperative treatment

Interventionparticipants (Number)
Sorafenib5

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Clinical Response Rate (Complete Pathologic Response Rate After Surgery)

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen during follow-up. Presence of in situ cancer alone will be considered a pCR but may be recorded separately. (NCT01194869)
Timeframe: Up to 2 years after definitive surgery

Interventionparticipants (Number)
Sorafenib0

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Clinical Response Rate During Follow-up (Disease Recurrence)

Response will be assessed according to World Health Organization criteria with progressive disease (PD) defined as a 25% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site. (NCT01194869)
Timeframe: Up to 2 years after definitive surgery

Interventionparticipants (Number)
Sorafenib6

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Progression-free Survival (Phase II)

Progression-free survival curves will be generated using Kaplan-Meier methodology. (NCT01196416)
Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years

Interventionmonths (Median)
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)2.7

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Participants Evaluated for Toxicity

Number of patients with AE's as assessed by NCI CTCAE v. 4.0 Please see Adverse Events section for specifics. (NCT01196416)
Timeframe: Up to 30 days post-treatment

InterventionParticipants (Count of Participants)
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)14

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Maximum Tolerated Dose for RO4929097

based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB) (NCT01196416)
Timeframe: 21 days

Interventionmg/day (Number)
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)15

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Cycle 1 Mean Day 2 Trough/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)

(NCT01196416)
Timeframe: At Day 2 of Cycle 1

Interventionng/mL (Mean)
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)129

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Cycle 1 C Max/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)

(NCT01196416)
Timeframe: At Cycle 1

Interventionng/mL (Mean)
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)301

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Cycle 1 AUC/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)

(NCT01196416)
Timeframe: Days 4 and 5

Interventionhr·ng/mL (Mean)
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)5410

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Overall Survival (Phase II)

Overall response rate (complete [CR] or partial response [PR]) according to RECIST version 1.1 (NCT01196416)
Timeframe: Up to 2 years

Interventionparticipants (Number)
Partial ResponseStable DiseaseProgression of Disease
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)356

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Number of Participants With Presence or Absence of Markers of Notch Signalling Pathway Inhibition in Patient Tumors (Phase Ib)

The association of response or clinical benefit with the presence or absence of markers of pathway inhibition in patient tumors will be tested using Fisher's exact test. (NCT01196416)
Timeframe: 2 weeks

InterventionParticipants (Count of Participants)
Insufficient tissue to asses any changeSig decrease in post-treatment cleaved Notch
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)14

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Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ

"based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB)~Data is not yet available, as it's currently being analyzed." (NCT01196416)
Timeframe: 21 days

Interventionmg/m2 (Number)
CisplatinVinblastineTemozolomide
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide)201.2150

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Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)

Here is the number of participants with serious and non-serious adverse events. For a detailed list of adverse events, see the adverse event module. (NCT01240590)
Timeframe: 4 years, 6 months and 26 days

Interventionparticipants (Number)
Ph I Level 1: Cisplatin + Crolibulin6
Ph I Level 2: Cisplatin + Crolibulin1
Ph II Level 3: Cisplatin + Crolibulin16
Ph II Level 4: Cisplatin1

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Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)

MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE). (NCT01240590)
Timeframe: 3 weeks

Interventionmg/m^2 (Number)
All Participants100

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Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)

MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE). (NCT01240590)
Timeframe: 3 weeks

Interventionmg/m^2 (Number)
All Participants20

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Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0

Adverse events at least possibly related to treatment (NCT01275664)
Timeframe: Up to day 6

InterventionParticipants (Count of Participants)
ConstipationFatigueDiarrheaHyponatremiaAlanine Aminotransferase IncreasedGGT Increased
Treatment (Granisetron, Dexamethasone, Aprepitant)111111

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Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)

Number of participants who had complete control defined by no vomiting (NCT01275664)
Timeframe: During the 6 days following chemotherapy

InterventionParticipants (Count of Participants)
Treatment (Granisetron, Dexamethasone, Aprepitant)1

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Recurrence Free Survival

Date of surgery to date of death or date of recurrence, whichever occurred first for patients who experienced an event, and to date of last follow-up for patients alive without recurrence (NCT01277744)
Timeframe: 36 months after the last participant enrolled

Interventionmonths (Median)
HIPEC13.99

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Overall Survival

From the date of diagnosis to the date of death or last follow up date for patient alive. (NCT01277744)
Timeframe: From the date of diagnosis to the date of death or last follow up date for patient alive up to 81 months

Interventionmonths (Median)
HIPEC58.4

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)

AE was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication [maximum duration: 35.7 months]). (NCT01285557)
Timeframe: From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)

,
InterventionParticipants (Count of Participants)
TEAETESAE
5FU+Cisplatin11131
S-1+Cisplatin21463

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Duration of Response (DR)

Duration of response was defined as the time (in months) from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to <10 mm. Analysis was performed by using Kaplan-Meier method. (NCT01285557)
Timeframe: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)

Interventionmonths (Median)
S-1+Cisplatin5.1
5FU+Cisplatin4.2

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Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3

An AE was any untoward medical condition that occurred in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication [maximum duration: 35.7 months]). (NCT01285557)
Timeframe: From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)

InterventionParticipants (Count of Participants)
S-1+Cisplatin157
5FU+Cisplatin78

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Overall Response Rate (ORR): Percentage of Participants With Overall Response

ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) based on the Investigator review of the images and application of Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to less than (<) 10 millimeter (mm). PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference. (NCT01285557)
Timeframe: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)

Interventionpercentage of participants (Number)
S-1+Cisplatin34.7
5FU+Cisplatin19.8

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Overall Survival (OS)

OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method. (NCT01285557)
Timeframe: From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months)

Interventionmonths (Median)
S-1+Cisplatin7.5
5FU+Cisplatin6.6

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Progression-free Survival (PFS)

PFS was defined as the time from date of randomization until date of radiological disease progression or death due to any cause. Disease Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where any of the 3 criteria have been met: 1) at least 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, including the baseline sum, 2) Progression in no-target lesion(s), 3) appearance of new lesion(s) Participants who were alive with no PD were censored at the date of the last tumor assessment. Participants who received new anticancer therapy before disease progression were censored at the date of the last evaluable tumor assessment before new anticancer therapy was initiated. Analysis was performed by using Kaplan-Meier method. (NCT01285557)
Timeframe: From date of randomization until disease progression or death, cut-off date: 07 March 2014 (approximately 34.7 months)

Interventionmonths (Median)
S-1+Cisplatin4.4
5FU+Cisplatin3.9

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Time to Treatment Failure (TTF)

TTF was defined as the time from date of randomization until date of PD (clinical or radiologic), or permanent discontinuation of study treatment (S-1 or 5-FU), or death due to any cause. Participates who were still on study treatment at the time of the analysis were censored at the last date the participants was known to be on treatment. (NCT01285557)
Timeframe: From date of randomization until disease progression, cut-off date: 07 March 2014 (approximately 34.7 months)

Interventionmonths (Median)
S-1+Cisplatin4.2
5FU+Cisplatin3.8

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Time to Tumor Response (TTR)

TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to <10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference. Analysis was performed by using Kaplan-Meier method. (NCT01285557)
Timeframe: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)

Interventionmonths (Median)
S-1+Cisplatin1.8
5FU+Cisplatin1.9

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HRQOL and Swallowing Function

The European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and disease specific questionnaires (QLQ-OES24/OG25). All items included in the questionnaires are analysed and also separate analysis of dysphagia questionnaires for oesophageal cancer were used, both clinically and psychometrically validated. All questions have four response alternatives (1, not at all; 2:a little, 3: quite a bit, 4: very much), except global scales which comprise seven response alternatives from poor to excellent. Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 according to the EORTC scoring manual. A higher score indicates either more symotoms or better function, depending on the question. (NCT01362127)
Timeframe: Entry study up to Five years follow up

,
Interventionunits on a scale (Mean)
Mean global QoLDysphagia score all
Chemotherapy6931
Radiochemotherapy6727

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Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.

Chireac tumour regression grade (NCT01362127)
Timeframe: Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.

InterventionParticipants (Count of Participants)
Radiochemotherapy22
Chemotherapy7

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Safety of Respective Neoadjuvant Therapies.

Safety profile of carrying out radical surgery after respective neoadjuvant therapy. (NCT01362127)
Timeframe: Five years follow up

InterventionParticipants (Count of Participants)
Radiochemotherapy79
Chemotherapy81

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Progression-free Survival Rate at 5 Years

Estimate for probability of progression free at 5 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the time of disease progression, death from any cause or date of last contact, whichever occurs first. Disease progression is defined by increasing clinical, radiological or pathological evidence of disease from participant entry to when investigator deems a progression. RECIST V1.0 was not used to determine response on this study. (NCT01414608)
Timeframe: 5 years from study randomization

InterventionPercentage of participants (Number)
Standard Chemoradiation62
Standard Chemoradiation With Adjuvant Chemotherapy63

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Overall Survival Rate at 5 Years

Estimate for probability of overall survival at 5 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first. (NCT01414608)
Timeframe: 5 years from study randomization

InterventionPercentage of participants (Number)
Standard Chemoradiation71
Standard Chemoradiation With Adjuvant Chemotherapy72

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Quality of Life for Global Health Status

Quality of Life measured by change of global health status score from baseline to 12 months follow-up. A cancer-specific questionnaire with 30 items which summarize as five functioning scales, a global health status/quality of life scale, three symptom scales and six single items assessing additional symptoms and perceived financial impact. The minimum global health status score was 0 and the maximum global health status score was 100. A higher global health status score means better outcome. (NCT01414608)
Timeframe: Baseline and 12 months

Interventionscore on a scale (Mean)
Standard Chemoradiation1.7
Standard Chemoradiation With Adjuvant Chemotherapy2.4

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Number of Participants With Adverse Events (Grade 3 or Higher) in First Year

Number of participants with a maximum grade of 3 or higher for pre-specified adverse events that occurred during the first year after randomization. Adverse events are graded and categorized using CTCAE v4.0. (NCT01414608)
Timeframe: 1 year after randomization

,
InterventionParticipants (Count of Participants)
Abdominal painAlanine aminotransferase increasedAllergic reaction/hypersensitivityAlopeciaAnemiaAspartate aminotransferase increasedColitisColonic obstructionCreatinine IncreasedCystitis noninfectiveDehydrationDermatitis radiationDiarrheaEnterocolitisFatigueFebrile NeutropeniaFemale genital tract fistulaHearing impairedHemorrhage bladderHemorrhage rectumLymphocyte count decreasedMucositis oralMyalgiaNauseaNeutrophil count decreasedPain in extremityPelvic painPerineal painPeripheral motor neuropathyPeripheral sensory neuropathyPlatelet count decreasedProctitisSmall intestinal obstructionThrombosis/Thrombus/EmbolismTumor painUrinary tract painUterine obstructionVaginal DrynessVaginal painVaginal strictureVomiting
Standard Chemoradiation13410323213113121279403120820113331110152176110349
Standard Chemoradiation With Adjuvant Chemotherapy142216422133912039914302110311711604161604700211415

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Patterns of Disease Recurrence

Number of patients for the site of disease recurrence. Disease was considered as persistent if participant had evidence of disease at study entry and disease did not progress during study. Disease status was considered locoregional alone if a participant had disease progression in the pelvis region including vagina after study entry. Disease status was considered distant if a participant had disease progression outside the pelvis (for example the abdomen and lung) after study entry. Criteria used to determine the no progression group includes participants that expired without documentation of progression. (NCT01414608)
Timeframe: through study completion an average of 60 months

,
Interventionparticipants (Number)
PersistentLocoregional aloneDistant with or without locoregionalOther/UnknownNo Progression recorded
Standard Chemoradiation15335153304
Standard Chemoradiation With Adjuvant Chemotherapy5474237332

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Radiation Protocol Compliance

Radiation protocol compliance measured by external beam dose delivered (NCT01414608)
Timeframe: Average duration of 7 weeks

InterventionGray (Mean)
Arm A45.6
Arm B45.7

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Overall Survival Rate

The percentage of participants who are still alive from the start of treatment. (NCT01530997)
Timeframe: Median follow-up was 36 months with a range of 5-53 months.

Interventionpercentage of participants (Number)
Single Intervention95

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Cause-Specific Survival

Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC. (NCT01530997)
Timeframe: The median follow-up was 36 months with a range of 5-53 months

Interventionpercentage of participants (Number)
Single Intervention100

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Distant Metastases Free Survival

Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread. (NCT01530997)
Timeframe: the median follow-up was 36 months with a range of

Interventionpercentage of participants (Number)
Single Intervention100

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Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens. (NCT01530997)
Timeframe: 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened

InterventionParticipants (Count of Participants)
De-escalated Radiation and Chemotherapy37

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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35

"The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality.~The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning)." (NCT01530997)
Timeframe: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT

,,
Interventionunits on a scale (Mean)
PainSwallowingSenses ProblemsSpeech ProblemsTrouble with Social EatingTrouble with Social ContactLess SexualityTeethOpening MouthDry MouthSticky SalivaCoughFelt IllPain KillersNutritional SupplementsFeeding TubeWeight LossWeight Gain
6-8 Weeks Post-Treatment251935132915341015696125204355403840
Baseline1911510851335166178343902025
Post-Surgery26182816248231218644922113340173610

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Regional Control

Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin. (NCT01530997)
Timeframe: Median follow-up was 36 months with a range of 5-53 months

Interventionpercentage of participants (Number)
Single Intervention100

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The Eating Assessment Tool (EAT-10) Composite Score

The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40. (NCT01530997)
Timeframe: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT

Interventionunits on a scale (Mean)
Baseline4
6-8 Weeks Post-Treatment13
Post-Surgery11

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Two-Year Local Control

Local control is the arrest of cancer growth at the site of origin. (NCT01530997)
Timeframe: Median follow-up was 36 months with a range of 5-53 months

Interventionpercentage of participants (Number)
De-escalated Radiation and Chemotherapy100

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European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL

The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms. (NCT01530997)
Timeframe: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT

,,
Interventionunits on a scale (Mean)
Global health status/QoLPhysical functioningRole functioningEmotional functioningCognitive functioningSocial functioningFatigueNausea and vomitingPainDyspneaInsomniaAppetite lossConstipationDiarrheaFinancial difficulties
6-8 Weeks Post-Treatment61786577866642132111344017428
Baseline809696779188202155231412516
Post-Surgery698577848781314206233316622

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The Rosenbek Penetration Aspiration Scale

"The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances.~1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject." (NCT01530997)
Timeframe: Prior to CRT and 4-8 weeks after completion of CRT

,
Interventionunits on a scale (Mean)
Thin SubstancesPureed SubstancesSolid Substances
Post-treatment1.901.191.03
Pre-treatment1.301.031.03

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Patients With Adverse Events

Number of patients who experienced one or more adverse events (NCT01590017)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Cistplatin and Radiation Therapy39

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Treatment Completion Rate

Number of participants who completed therapy (NCT01590017)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Cistplatin and Radiation Therapy37

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Progression-free Survival (PFS)

Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1 (NCT01595061)
Timeframe: From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months

Interventionpercentage of participants (Number)
GEM+CIS+IMRT75

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Adverse Events (Grade 3 or Higher) During Treatment Period

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. (NCT01595061)
Timeframe: During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.

InterventionParticipants (Count of Participants)
LeukopeniaThrombocytopeniaNeutropeniaAnemiaOther InvestigationsOther blood and lymphatic disordersCardiac disordersGastrointestinal disordersGeneral disorders and administration site conditionsInfections and infestationsInjury, poisoning and procedural complicationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersPeripheral sensory neuropathyOther nervous system disordersRenal and urinary disordersReproductive system and breast disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersSurgical and medical proceduresVascular disorders
GEM+CIS+IMRT2720202078210552019212171415

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Complete Pathologic Response

Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy. (NCT01595061)
Timeframe: 6 -8 weeks after completion of chemo-radiation

Interventionpercentage of participants (Number)
GEM+CIS+IMRT73.6

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Complete Clinical Response

Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy. (NCT01595061)
Timeframe: 6-8 weeks after completion of chemo-radiation

Interventionpercentage of participants (Number)
GEM+CIS+IMRT71.7

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Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.

Number of patients who no longer need radiation (have decreases in risk level post induction therapy). Estimations of Risk level pre-induction will be based on physical examination and imaging, post-induction risk level will be determined based on pathologic evaluation or surgical specimen. (NCT01612351)
Timeframe: 11 weeks

InterventionParticipants (Count of Participants)
Induction Chemotherapy Followed by Transoral Surgery29

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Overall Response Rate

Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT01612351)
Timeframe: 11 weeks

InterventionParticipants (Count of Participants)
Induction Chemotherapy Followed by Transoral Surgery37

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Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy

Pathologic complete response (pCR) is the disappearance of all signs of cancer in tissue samples removed during surgery or biopsy (pT0). Also called pathologic complete remission. Pathologic Partial Response (pPR), is the presence of only non-invasive cancer in tissue samples (NCT01612351)
Timeframe: 11 weeks

InterventionParticipants (Count of Participants)
Pathologic complete response (pCR)Pathologic Partial Response (pPR)
Induction Chemotherapy Followed by Transoral Surgery1425

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Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI)

The MD Anderson Dysphagia Inventory (MDADI) is a 20 item assessment designed to measure voice and swallowing function. Participants were asked 13 symptom questions and 6 interference items (walking, working) and asked id the 1- strongly agree to 5 strongly disagree. Scores were summed for a range of 20-100. The lower the score the worse the outcomes. (NCT01612351)
Timeframe: Pre-treatment up to 1 year post surgery

Interventionunits on a scale (Mean)
Pre-treatment83.90
Post-Induction86.26
1 Year Post Surgery81.90

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Feasibility of 3 Part Therapy

Percentage of patients successfully completing 3 part therapy will be used to assess the feasibility of 3 part therapy consisting of induction chemotherapy, surgery, and risk-adapted use of chemoradiation. (NCT01612351)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
completednot-completed
Induction Chemotherapy Followed by Transoral Surgery391

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Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0

The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. (NCT01612351)
Timeframe: 18 weeks

InterventionParticipants (Count of Participants)
Alanine aminotransferase increasedAspartate Aminotransferase increasedChest pain- cardiacDiarrheaFatigueFebrile neutropeniaHyperglycemiaHyponatremiaHypotensionLymphocyte count decreasedNauseaNeutrophil count decreasedPalmar-plantar erythrodysesthesia syndromePeripheral sensory neuropathyRash acneiformSepsisWhite blood cell decreased
Induction Chemotherapy Followed by Transoral Surgery2115441111122124115

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Response Rates at the Neck.

Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for neck lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT01612351)
Timeframe: 11 weeks

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable Disease
Non-Randomized Single-Arm11153

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Response Rates at the Primary Site

Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT01612351)
Timeframe: 11 weeks

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable Disease
Non-Randomized Single-Arm15213

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Overall Survival (OS)

Overall survival (OS) is defined as time from randomization to death from any cause. Median OS was estimated using the Kaplan-Meier method. (NCT01642251)
Timeframe: Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of death. No specific requirements if patient is > 3 years from registration

Interventionmonths (Median)
Phase II: Arm D (Veliparib)10.3
Phase II: Arm E (Placebo)8.9

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Neurotoxicity Total Score Change Between Baseline and 3 Months After Treatment Start

Neurotoxicity total score was measured by the 11 items in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire. Each item was scored from 0-4. The severity of neurotoxicity was measured by the total score of the 11 items, ranged from 0 to 44. Lower values of the FACT/GOG-Ntx neurotoxicity total score indicate higher neurotoxicity. (NCT01642251)
Timeframe: assessed at baseline and 3 months after treatment initiation

Interventionunits on a scale (Mean)
Phase II: Arm D (Veliparib)-0.1
Phase II: Arm E (Placebo)-1.8

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Overall Response Rate (ORR)

Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Complete response (CR) was defined as disappearance of all target lesions. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall response rate= (CR+PR)/all eligible and treated patients (NCT01642251)
Timeframe: assessed every 6 weeks while on study, then every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration.

Interventionpercentage of patients (Number)
Phase II: Arm D (Veliparib)72
Phase II: Arm E (Placebo)66

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Progression Free Survival (Phase II)

Profession free survival (PFS) is defined as time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date they were last known to be alive and progression-free. Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, and progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Median PFS was estimated using the Kaplan-Meier method. (NCT01642251)
Timeframe: Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of first documented progression or death. No specific requirements if patient is > 3 years from registration

,
Interventionmonths (Median)
Overall samplePatients within the male/abnormal LDH stratumPatients not within the male/abnormal LDH stratum
Phase II: Arm D (Veliparib)6.16.26.0
Phase II: Arm E (Placebo)5.55.15.6

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Clinical Response Rate

"Clinical response rate, defined as the number of partial and complete responses, after preoperative therapy with either cisplatin or AC in participants with germline BRCA mutation and breast cancer.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or ultrasound: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT01670500)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Doxorubicin-Cyclophosphamide43
Cisplatin45

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Rate of Pathologic Complete Response (pCR)

Pathologic complete response (pCR) rate (determined by the Miller-Payne method) in doxorubicin-cyclophosphamide vs cisplatin arms. (NCT01670500)
Timeframe: 3 years

Interventionpercentage of participants (Number)
Doxorubicin-Cyclophosphamide26
Cisplatin18

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Rate of Residual Cancer Burden (RCB) 0/1

Residual Cancer Burden (RCB) rate of RCB 0 or 1 in participants receiving Doxorubicin-Cyclophosphamide vs participants receiving Cisplatin. (NCT01670500)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Doxorubicin-Cyclophosphamide46
Cisplatin33

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Number of Grade 3 and Grade 4 Adverse Events

Comparison of toxicities for cisplatin and AC preoperative chemotherapy in BRCA mutation carriers with newly diagnosed breast cancer, reported as number of all Grade 3 and 4 adverse events and number of non-hematologic Grade 3 and 4 adverse events. (NCT01670500)
Timeframe: 2 years

,
InterventionAdverse Events (Number)
All Grade 3 & 4 Adverse EventsNon-hematologic Grade 3 & 4 Adverse Events
Cisplatin1611
Doxorubicin-Cyclophosphamide154

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Rate of Miller Payne 4 and 5

"Rates of Miller Payne 4 (near pCR) and 5 (near pCR) combined between those subjects who received neoadjuvant cisplatin and those who received neoadjuvant AC.~Definitions:~Miller Payne 4: a marked disappearance of tumor cells (more than 90%) such that only small clusters or widely dispersed individual cells remain (almost pCR);~Miller Payne 5: no malignant cells identifiable in sections from the site of the tumor (pCR)" (NCT01670500)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Doxorubicin-Cyclophosphamide30
Cisplatin22

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Objective Tumor Response

Objective tumor response was measured using modified Response Evaluation Criteria in Solid Tumors (mRECIST) for assessment of response in malignant pleural mesothelioma (MPM). Per mRECIST for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, those who fulfilled the criteria for neither PR nor PD; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions. (NCT01675765)
Timeframe: Baseline to measured disease progression or death (up to 12 months or longer)

,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Assessable
Immunotherapy Plus Chemotherapy1191411
Immunotherapy With Cyclophosphamide Plus Chemotherapy011820

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Number of Subjects Reporting Adverse Events

Count of subjects with incidences of adverse events. (NCT01675765)
Timeframe: From first study dose until 28 days after the final dose (an average of 44 weeks)

InterventionParticipants (Count of Participants)
Immunotherapy Plus Chemotherapy38
Immunotherapy With Cyclophosphamide Plus Chemotherapy22

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Number of Adverse Events

"In part A the maximum tolerated dose (MTD) of BIBW 2992 administered continuously to the standard therapy of Gemcitabine / Cisplatin (Gem/Cis) (administered together on day 1 and 8 of a three-week cycle) will be evaluated in a 2 step dose escalation.~Safety and toxicity will be evaluated as described and considered primary for part B of the study." (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period.

InterventionParticipants (Count of Participants)
Dose Level 12
Dose Level -11

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Objective Response Rate

Response was assessed by means of RECIST 1.1 criteria for target lesions, non-target lesions and the appearance of new lesions. Objective response was defined as the CR, PR or SD at end of treatment (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months).

InterventionParticipants (Count of Participants)
Dose Level 10
Dose Level -10

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Overall Survival (OS)

Median overall survival time including the 95% confidence interval were determined using Kaplan-Meier estimates. (NCT01679405)
Timeframe: Time from start of treatment to death due to any cause. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored. Estimated time period: up to 76 weeks

Interventiondays (Median)
Dose Level 1163
Dose Level -1260

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Time to Progress (TTP)

Median time to progress (according to RECIST 1.1 criteria) including the 95% confidence intervals were determined using Kaplan-Meier estimates. Time from start of treatment to first documentation of objective tumour progression. Deaths were censored at the time of death. (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period.

Interventiondays (Median)
Dose Level 1159
Dose Level -1NA

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Tumor Control Rate

Tumor control rate is defined as the best tumour response (confirmed partial or complete response, stable disease) that is achieved until end of treatment according to Recist 1.1. (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months).

InterventionParticipants (Count of Participants)
Dose Level 10
Dose Level -14

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Rate of Distant Metastasis

Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone. (NCT01687413)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Radiotherapy2
Radiotherapy, Cisplatin0

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Locoregional Control

Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins. (NCT01687413)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Radiotherapy26
Radiotherapy, Cisplatin9

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Disease Specific Survival

(NCT01687413)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Radiotherapy24
Radiotherapy, Cisplatin10

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Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity

"1 question that asks about taste acuity~Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity~The higher the score the worse the participant's taste acuity" (NCT01687413)
Timeframe: Baseline, 1 month, 6 months, and 12 months

Interventionscore on a scale (Mean)
Baseline - Radiotherapy1.0833333
Baseline - Radiotherapy + Cisplatin0.9090909
1 Month - Radiotherapy2.1363636
1 Month - Radiotherapy + Cisplatin2.9090909
6 Months - Radiotherapy0.9285714
6 Months - Radiotherapy + Cisplatin2.4285714
12 Months - Radiotherapy1.0000000
12 Months - Radiotherapy + Cisplatin1.5714286

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Change in Cognitive Function as Measured by Cognitive Failures Questionnaire

"25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering~Answers range from 0 = never to 4 = very often~The higher the score the worse the cognitive failures the participant has experienced" (NCT01687413)
Timeframe: Baseline, 1 month, 12 months, and 24 months

,,,,,,,
Interventionscore on a scale (Mean)
Do you read something and find you haven't been thinking about it and must read it again?Do you find you forget why you went from one part of the house to the other?Do you fail to notice signposts on the road?Do you find you confuse right and left when giving directions?Do you bump into people?Do you find you forget whether you've turned off a light or a fire or locked the door?Do you fail to listen to people's names when you are meeting them?Do you say something and realize afterwards that it might be taken as insulting?Do you fail to hear people speaking to you when you are doing something else?Do you lose your temper and regret it?Do you leave important letters unanswered for days?Do you find you forget which way to turn on a road you know well but rarely use?Do you fail to see what you want in a supermarket (although it's there)?Do you find yourself suddenly wondering whether you've used a word correctly?Do you have trouble making up your mind?Do you find you forget appointments?Do you forget where you put something like a newspaper or a book?Do you find you accidentally throw away the thing you want and keep what you meant to throw away?Do you daydream when you out to be listening to something?Do you find you forget people's names?Do you start doing one thing at home and get distracted into doing something else (unintentionally)?Do you find you can't quite remember something although it's on the tip of your tongue?Do you find you forget what you came to the shops to buy?Do you drop things?Do you find you can't think of anything to say?
1 Month - Radiotherapy1.54545451.27272730.72727270.45454550.36363640.86363641.81818181.00000001.40909091.09090911.00000000.40909090.90909090.77272731.00000000.77272731.13636360.54545451.18181821.86363641.54545451.81818181.13636360.81818180.8636364
1 Month - Radiotherapy + Cisplatin1.27272731.00000000.54545450.27272730.18181820.63636361.09090910.81818181.09090910.81818180.45454550.54545450.54545450.63636360.90909090.63636360.81818180.18181820.90909091.63636361.00000001.27272730.36363640.63636360.9090909
12 Months - Radiotherapy1.46666671.3333330.66666670.26666670.46666671.13333332.00000001.06666671.40000000.86666670.78571430.33333331.06666670.80000000.93333330.53333331.40000000.66666671.00000002.06666671.33333331.73333331.26666670.66666670.8000000
12 Months - Radiotherapy + Cisplatin2.16666671.50000000.83333330.33333330.83333331.33333331.33333331.00000001.83333330.83333330.83333330.50000001.00000000.66666671.00000000.83333331.33333330.33333330.83333331.66666672.33333332.00000001.16666671.33333331.1666667
24 Months - Radiotherapy1.56250001.43750000.62500000.37500000.31250000.73333331.62500001.25000001.43750000.81250000.81250000.31250000.87500000.75000001.06250000.62500001.12500000.62500001.00000001.81250001.31250001.62500000.75000001.00000001.0000000
24 Months - Radiotherapy + Cisplatin1.57142861.42857140.85714290.57142860.57142861.28571431.42857140.85714291.57142861.42857141.00000000.28571430.71428570.85714291.14285711.00000001.57142860.57142860.85714291.85714291.42857141.57142860.71428570.85714291.0000000
Baseline - Radiotherapy1.41666671.20833330.66666670.33333330.25000000.95833331.70833331.00000001.37500000.95833330.66666670.47826090.62500000.58333330.95833330.58333331.04166670.54166671.12500001.83333331.25000001.41666670.83333330.45833330.7916667
Baseline - Radiotherapy + Cisplatin1.36363641.09090910.36363640.27272730.18181820.63636361.09090910.90909091.27272731.00000000.63636360.45454550.45454550.63636360.90909090.54545451.000000000.18181821.27272731.63636361.09090911.45454550.63636360.81818180.5454545

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Change in Hearing as Measured by Hearing Handicap Inventory - Adult

"11 item questionnaire to identify issues with hearing~Answers are yes = 4, sometimes = 2, and no = 0~The higher the score the more issues the participant has with hearing" (NCT01687413)
Timeframe: Baseline, 1 month, and 12 months

,,,,,
Interventionscore on a scale (Mean)
Does a hearing problem cause you to feel embarrassed when you meet new people?Does a hearing problem cause you to feel frustrated when talking to members of your family?Do you have difficulty hearing or understanding co-workers or clients or customers?Do you feel that any difficulty with your hearing limits or hampers your personal or social life?Do you feel handicapped by a hearing problem?Does a hearing problem cause you difficulty in the movies or in the theater?Does a hearing problem cause you difficulty when in a restaurant with relatives or friends?Does a hearing problem cause you to attend religious services less often than you would like?Does a hearing problem cause you to have argments with family members?Does a hearing problem cause you difficulty when listening to TV or radio?Does a hearing problem cause you difficulty when visiting friends or relatives or neighbors?
1 Month - Radiotherapy0.23809520.52380950.66666670.38095240.14285710.52380950.61904760.00000000.10000000.85714290.1904762
1 Month - Radiotherapy + Cisplatin0.18181820.36363641.09090910.72727270.36363640.27272730.81818180.00000000.18181820.45454550.4545455
12 Months - Radiotherapy0.13333330.13333330.13333330.20000000.06666670.13333330.26666670.00000000.26666670.40000000.1333333
12 Months - Radiotherapy + Cisplatin1.00000000.71428571.71428570.71428570.71428570.42857141.57142860.00000000.14285710.71428570.7142857
Baseline - Radiotherapy0.25000000.12500000.50000000.16666670.12500000.16666670.21739130.04166670.25000000.37500000.3333333
Baseline - Radiotherapy + Cisplatin0.54545450.18181821.09090910.63636360.54545450.45454550.72727270.18181820.18181820.45454550.6363636

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Change in Quality of Life as Measured by EORTC QLQ-C30

"30 questions designed to assess the quality of life of cancer patients~The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life~The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life" (NCT01687413)
Timeframe: Baseline, 1 month, 6 months, 12 months, and 24 months

,,,,,,,,,
Interventionscore on a scale (Mean)
Do you have trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase?Do you have any trouble taking a long walk?Do you have any trouble taking a short walk outside of the house?Do you need to stay in bed or a chair during the day?Do you need help with eating, dressing, washing yourself or using the toilet?Were you limited in doing either your work or other daily activities?Were you limited in pursuing your hobbies or other leisure time activities?Were you short of breath?Have you had pain?Did you need to rest?Have you had trouble sleeping?Have you felt weak?Have you lacked appetite?Have you felt nauseated?Have you vomited?Have you been constipated?Have you had diarrhea?Were you tired?Did pain interfere with your daily activities?Have you had difficulty in concentrating on things, like reading a newspaper or watching televisionDid you feel tense?Did you worry?Did you feel irritable?Did you feel depressed?Have you had difficulty remembering things?Has your physical condition or medical treatment interfered with your family life?Has your physical condition or medical treatment interfered with your social activities?Has your physical condition or medical treatment caused you financial difficulties?How would you rate your overall health during the past week?How would you rate your overall quality of life during the past week?
1 Month - Radiotherapy1.77272731.36363641.04545451.22727271.09090911.40909091.45454551.13636361.50000001.59090911.54545451.68181821.63636361.18181821.04545451.63636361.13636361.1818181.23809521.28571431.40909091.45454551.40909091.31818181.54545451.31818181.59090911.59090915.40909095.6363636
1 Month - Radiotherapy + Cisplatin1.45454551.27272731.00000001.09090911.00000001.27272731.45454551.36363641.72727271.63636361.63636361.45454551.36363641.18181821.00000001.09090911.00000001.72727271.30000001.27272731.27272731.27272731.27272731.18181821.63636361.36363641.72727271.90909095.54545455.6363636
12 Months - Radiotherapy1.26666671.26666671.00000001.26666671.00000001.20000001.13333331.26666671.60000001.60000001.93333331.33333331.20000001.13333331.00000001.13333331.20000001.73333331.33333331.40000001.40000001.40000001.33333331.33333331.60000001.20000001.33333331.46666676.06666676.1333333
12 Months - Radiotherapy + Cisplatin1.57142861.14285711.14285711.28571431.28571431.28571431.42857141.42857141.85714291.85714292.00000001.57142861.28571431.00000001.00000001.57142861.14285712.14285711.57142861.57142861.42857142.00000001.85714291.71428572.14285711.57142861.57142861.85714295.57142865.7142857
24 Months - Radiotherapy1.43750001.25000001.00000001.18750001.00000001.37500001.25000001.18750001.68750001.68750001.37500001.56250001.50000001.18750001.00000001.40000001.06666671.43750001.13333331.31250001.18750001.43750001.31250001.31250001.43750001.06250001.12500001.43750005.75000006.0000000
24 Months - Radiotherapy + Cisplatin1.62500001.25000001.12500001.00000001.00000001.00000001.37500001.37500002.00000001.62500002.12500001.37500001.12500001.00000001.00000001.75000001.12500001.75000001.00000001.25000001.75000002.00000001.62500001.50000001.87500001.12500001.37500001.87500005.75000006.0000000
6 Months - Radiotherapy1.35714291.21428571.07142861.14285711.07142861.42857141.28571431.14285711.71428571.50000001.35714291.53846151.35714291.21428571.07142861.21428571.14285711.64285711.28571431.35714291.28571431.35714291.14285711.21428571.71428571.21428571.14285711.71428575.92857146.1428571
6 Months - Radiotherapy + Cisplatin1.71428571.14285711.14285711.28571431.14285711.14285711.42857141.42857141.85714291.71428572.42857141.42857141.28571431.14285711.00000001.14285711.14285711.85714291.42857141.57142861.57142862.00000001.71428571.57142861.85714291.42857141.71428572.14285715.28571435.4285714
Baseline - Radiotherapy2.00000001.75000001.08333331.45833331.08333332.08333332.00000001.29166672.00000001.91666671.83333331.91666671.69565221.16666671.08333331.50000001.04166672.00000001.66666671.45833331.37500001.91666671.41666671.54166671.41666671.79166672.04166671.54166675.20833335.0416667
Baseline - Radiotherapy + Cisplatin2.00000001.09090911.00000001.00000001.09090911.63636361.63636361.00000001.72727271.54545452.27272731.81818181.63636361.36363641.00000001.81818181.18181822.00000001.72727271.27272731.54545452.00000001.54545451.45454551.27272731.54545451.90909092.36363645.27272735.1818182

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Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)

"-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from not at all to a lot. The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot)." (NCT01687413)
Timeframe: Baseline, 12 months, and 24 months

,,,,,
Interventionscore on a scale (Mean)
Neck or shoulder pain or discomfortNeck or shoulder stiffnessDifficulty with self-care activities because of neck or shoulderLimited ability to life light objects because of your shoulder or neckLimited ability to lift heavy objects because of your shoulder or neckLimited ability to reach for objects because of your shoulder or neckOverall activity level because of your shoulder or neckHas the treatment of your neck affected your participation in social activities?Limited in ability to do leisure or recreational activities because of your neck or shoulder?Limited in ability to do work including work at home because of neck or shoulder discomfort or pain?
12 Months - Radiotherapy1.46666671.00000000.33333330.40000000.53333330.53333330.53333330.06666670.20000000.2666667
12 Months - Radiotherapy + Cisplatin2.42857142.42857141.00000000.85714291.57142861.71428571.57142860.85714291.42857141.2857143
24 Months - Radiotherapy1.31250001.18750000.25000000.25000000.46666670.56250000.37500000.18750000.25000000.1250000
24 Months - Radiotherapy + Cisplatin1.75000001.75000000.50000000.50000000.87500000.75000000.62500000.50000000.75000000.5000000
Baseline - Radiotherapy1.60869571.45454550.86956520.65217391.60869571.21739131.00000000.73913041.08695651.1304348
Baseline - Radiotherapy + Cisplatin2.09090912.00000001.27272731.63636362.27272732.09090911.90909090.90909091.72727271.7272727

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Change in Quality of Life as Measured by Speech Handicap Index

"31 questions regarding participant's speech and the effects of speech on his/her life~The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4~The higher the score the worse the participant's speech is affecting his/her life" (NCT01687413)
Timeframe: Baseline and 12 months

,,,
Interventionscore on a scale (Mean)
My speech makes it difficult for people to understand meI run out of air when I speakThe intelligibility of my speech varies throughout the dayMy speech makes me feel incompetentPeople ask me why I'm hard to understandI feel annoyed when people ask me to repeatI avoid using the phoneI'm tense when talking to others because of my speechMy articulation is unclearPeople have difficulty understanding me in a noisy roomI tend to avoid groups of people because of my speechPeople seem irritated with my speechPeople ask me to repeat myself when speaking face-to-faceI speak with friends and neighbors and relatives less often because of my speechI feel ask though I have to strain to speakI find other people don't understand my speaking problemMy speaking difficulties restrict my person and social lifeThe intelligibility is unpredictableI feel left out of conversations because of my speechI use a great deal of effort to speakMy speech is worse in the eveningMy speech problem causes me to lose incomeI try to change my speech to sound differentMy speech problem upsets meI am less outgoing because of my speech problemMy family has difficulty understanding me when I call them throughout the houseMy speech makes me feel handicappedI have difficulties to continue a conversation because of my speechI feel embarrassed when people ask me to repeatI'm ashamed of my speech problemHow do you rate your own speech at this moment?
12 Months - Radiotherapy1.33333331.26666671.40000001.13333331.13333331.33333331.13333331.06666671.46666671.60000001.26666671.13333331.33333331.26666671.20000001.06666671.20000001.13333331.33333331.26666671.33333331.00000001.06666671.26666671.06666671.13333331.06666671.13333331.00000001.00000001.3846154
12 Months - Radiotherapy + Cisplatin1.83333331.83333331.83333331.50000001.33333331.66666671.66666671.66666671.83333331.83333331.83333331.50000001.83333331.50000002.00000001.33333331.50000001.50000001.42857141.85714291.85714291.42857141.28571431.85714291.42857141.57142861.57142861.85714291.28571431.28571431.5714286
Baseline - Radiotherapy1.95652171.50000002.00000001.37500001.29166671.37500001.62500001.41666671.83333331.87500001.25000001.12500001.54166671.41666671.8333331.16666671.37500001.58333331.20833331.87500001.62500001.29166671.29166671.20833331.25000001.50000001.33333331.50000001.20833331.08333332.1304348
Baseline - Radiotherapy + Cisplatin1.72727271.45454551.54545451.27272731.18181821.27272731.54545451.54545451.81818181.81818181.7272771.36363641.72727271.27272731.90909091.27272731.27272731.36363641.36363641.63636361.63636361.81818181.09090911.54545451.45454551.63636361.45454551.54545451.36363641.27272731.4545455

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Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory

"Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5~The lower the score the lower the quality of life" (NCT01687413)
Timeframe: Baseline, 1 month, 6 months, 12 months, and 24 months

,,,,,,,,,
Interventionscore on a scale (Mean)
My swallowing ability limits my day to day activities.I am embarrassed by my eating habits.Swallowing is more difficult at the end of the day.I do not feel self-conscious when I eat.I am upset by my swallowing problem.People have difficulty cooking for me.Swallowing takes great effort.I do not go out because of my swallowing problem.My swallowing difficulty has caused me to lose income.It takes me longer to eat because of my swallowing problem."People ask me, Why can't you eat that?"Other people are irritated by my eating problem.
1 Month - Radiotherapy4.18181824.18181823.80952383.90909092.86363643.77272733.95454554.31818184.50000003.18181824.00000004.5454545
1 Month - Radiotherapy + Cisplatin4.18181824.45454554.09090914.18181822.63636364.27272733.90909094.18181824.36363642.90909093.72727274.3636364
12 Months - Radiotherapy4.50000004.42857144.28571434.07692312.78571434.21428573.92857144.64285714.64285713.50000004.21428574.5714286
12 Months - Radiotherapy + Cisplatin3.28571433.14285714.14285713.71428573.14285713.71428573.14285714.14285713.85714293.00000003.00000004.1428571
24 Months - Radiotherapy3.93750004.12500004.40000003.68750003.06250003.93750003.56250004.18750004.60000002.87500004.18750004.3750000
24 Months - Radiotherapy + Cisplatin4.62500004.12500004.75000004.50000003.25000004.12500003.37500004.25000004.50000003.12500004.50000004.3750000
6 Months - Radiotherapy4.30769234.38461544.61538464.38461543.15384623.76923083.69230774.53846154.61538463.07692314.15384624.6923077
6 Months - Radiotherapy + Cisplatin3.57142863.85714293.85714293.71428572.28571433.14285713.00000003.85714294.00000002.14285713.42857143.8571429
Baseline - Radiotherapy3.26086963.54545453.36363643.39130433.22727273.21739133.08695653.91304354.26086962.59090914.08695654.2608696
Baseline - Radiotherapy + Cisplatin4.00000004.45454554.54545454.09090912.09090913.90909093.45454554.63636363.90909092.40000004.00000004.2727273

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Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire

"It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.~The higher the score the worse the participant's xerostomia" (NCT01687413)
Timeframe: Baseline, 1 month, 6 months, 12 months, and 24 months

,,,,,,,,,
Interventionscore on a scale (Mean)
Rate your difficulty in talking due to drynessRate your difficulty chewing due to drynessRate your difficulty in swallowing solid food due to drynessRate the frequency of your sleeping problems due to drynessRate your mouth or throat dryness when eating foodRate your mouth or throat dryness while not eatingRate the frequency of sipping liquids to aid swallowing foodRate the frequency of sipping liquids for oral comfort when not eating
1 Month - Radiotherapy2.80952383.52380953.42857143.28571433.85714293.85714295.14285714.6190476
1 Month - Radiotherapy + Cisplatin3.90909093.18181823.90000003.00000003.72727273.09090914.00000003.3636364
12 Months - Radiotherapy2.56250002.62500003.37500002.25000003.50000003.25000005.06250003.8750000
12 Months - Radiotherapy + Cisplatin3.57142863.71428574.14285713.57142864.00000003.42857145.00000003.7142857
24 Months - Radiotherapy3.68750003.62500004.12500002.60000003.87500003.75000005.31250004.0000000
24 Months - Radiotherapy + Cisplatin3.12500002.75000003.25000002.75000003.37500002.62500004.12500002.7500000
6 Months - Radiotherapy3.00000003.07142863.50000001.71428573.50000002.64285715.00000003.4285714
6 Months - Radiotherapy + Cisplatin4.85714294.57142865.28571434.42857145.71428574.71428576.71428575.2857143
Baseline - Radiotherapy2.33333332.39130432.69565221.79166672.21739132.12500003.17391302.9565217
Baseline - Radiotherapy + Cisplatin1.36363641.45454551.63636361.54545451.81818181.54545452.27272732.0909091

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Number of Complications/Acute Toxicity by Organ Class

-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (NCT01687413)
Timeframe: Approximately 18 weeks

,
Interventionnumber of adverse events (Number)
Blood and lymphatic system disordersCardiac disordersEar and labyrinth disordersEye disordersGastrointestinal disordersGeneral disordersImmune system disordersInfections and infestationsInjury, poisoning and procedureal complicationsInvestigationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersNeoplasms benign, malignant and unspecified (incl cysts and polyps)Nervous system disordersPsychiatric disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersSurgical and medical proceduresVascular disorders
Radiotherapy50112104381731201115148163432311
Radiotherapy, Cisplatin121406117029602690299141406

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Number of Participants With Disease-free Survival (DFS)

(NCT01687413)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Radiotherapy24
Radiotherapy, Cisplatin10

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Toxicity (Phase I and Phase II)

Adverse Events were collected each cycle during treatment and follow-up according to the CTCAE v4.0 guidelines. The worst graded adverse event was determined for each patient. Below is a table of the number of patients that reported a Grade 3 or Grade 4 or Grade 5 as their worst reported event. (NCT01711541)
Timeframe: upt to 5 years

,,,,
InterventionParticipants (Count of Participants)
Grade 3 Adverse EventGrade 4 Adverse EventGrade 5 Adverse Event
Dose Level 0030
Dose Level 0B210
Dose Level 1210
Dose Level 2400
Dose Level 3610

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Dose Limiting Toxicity (Phase I)

"Dose Limiting Toxicity (DLTs) will be assessed during the first cycle of induction chemotherapy.~The following events are considered DLTs: Grade 4 neutropenia (ANC < 500) lasting more than 14 days, Febrile neutropenia, Grade 4 thrombocytopenia, dose delay of greater than 3 weeks due to failure to recover counts, treatment-related grade 3 or grade 4 non-hematological toxicity (excluding alopecia, fatigue, hypersensitivity reaction, nausea, vomiting, constipation, diarrhea, hypokalemia, hypomagnesemia, hypocalcemia, hypophosphatemia, and grade 3 hypertension), a dose delay of greater than 3 weeks for non-hematological toxicity despite replacement of electrolytes, maximum treatment for diarrhea, nausea, vomiting, and hypertension, any drug-related death.~The number of patients reporting a DLT are reported below. The maximum tolerated dose (MTD) will be determined as the highest dose where 1 or fewer out of 6 patients reports a DLT." (NCT01711541)
Timeframe: Up to 3 weeks

InterventionParticipants (Count of Participants)
Dose Level 00
Dose Level 0B0
Dose Level 10
Dose Level 20
Dose Level 31

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Number of Subjects Completing Therapy Including Surgical Resection.

This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure. (NCT01726582)
Timeframe: At time of surgery (approximately 10 to 20 weeks after screening)

InterventionParticipants (Count of Participants)
Milestones Related to Usual Therapy107

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Overall Survival in Months

This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection. (NCT01726582)
Timeframe: 5 years

InterventionMonths (Median)
Milestones Related to Therapy (Resected)45
Milestones Related to Therapy (Non-Resected)11

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Use of Biomarkers to Determine Course of Treatment

The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment. (NCT01726582)
Timeframe: Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)

InterventionParticipants (Count of Participants)
Milestones Related to Usual Therapy92

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Progression-free Survival

This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy. (NCT01726582)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Milestones Related to Usual Therapy36

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Number of Participants With Dose Limiting Toxicities

Grade 3 or 4 neutropenia (ie. absolute neutrophil count <1000 cells/mm^3) that was associated with a fever>38.5 degrees C or lasting longer than 5 days, grade 3 thrombocytopenia with bleeding or grade 4 thrombocytopenia, and any grade 3 or 4 non-hematologic toxicity per CTCAE criteria which were probably or definitely related to study therapy. During the chemoradiation, an event of stomatitis, pharyngitis, mucositis, or dermatitis was not considered to be a dose limiting toxicity unless it was a grade 4 that did resolve to NCT01732640)
Timeframe: 1 year (average)

InterventionParticipants (Count of Participants)
20 mg Afatinib2
30 mg Afatinib3

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Maximum Tolerated Dose (MTD) of Afatinib

The maximally tolerated dose (MTD) was defined as the dose of afatinib in which <2 of 6 patients experience a DLT with the next higher dose having at least 2 of up to 6 patients experiencing a DLT. No dose escalations or de-escalations are permitted within each subject's treatment. (NCT01732640)
Timeframe: 1 Year (Average)

Interventionmg (Number)
All Study Participants20

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The Tolerability of BuMel Regimen

Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome [SOS] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria [CTC] v.4.0) during the Consolidation phase of therapy. (NCT01798004)
Timeframe: Up to 28 days post-consolidation therapy, up to 1 year

Interventionparticipants (Number)
All Patients9

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Progression-free Survival

Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

Interventionmonths (Median)
EGFR: Erlotinib21.1
EGFR: No Erlotinib9.2
ALK: Crizotinib14.7
ALK: No CrizotinibNA

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Percentage of Patients With Complete or Partial Response

Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

Interventionpercentage of participants (Number)
EGFR: Erlotinib50.0
EGFR: No Erlotinib26.7
ALK: Crizotinib66.7
ALK: No Crizotinib75.0

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Overall Survival

Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionMonths (Median)
EGFR: ErlotinibNA
EGFR: No Erlotinib35.9
ALK: CrizotinibNA
ALK: No CrizotinibNA

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Number of Patients With Grade 3-5 Adverse Events

Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionParticipants (Count of Participants)
EGFR: Erlotinib0
EGFR: No Erlotinib0
ALK: Crizotinib0
ALK: No Crizotinib0

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Local-regional Progression-free Survival

Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionMonths (Median)
EGFR: Erlotinib25.7
EGFR: No ErlotinibNA
ALK: Crizotinib14.7
ALK: No CrizotinibNA

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Distant Progression-free Survival

Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionMonths (Median)
EGFR: ErlotinibNA
EGFR: No Erlotinib35.9
ALK: CrizotinibNA
ALK: No Crizotinib20.1

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Overall Survival

Overall survival is defined as the time from study enrollment until death from any cause. (NCT01893801)
Timeframe: Over the course of the subjects' treatment and participation in study, approx 18 mos

Interventionmonths (Median)
Nab-Pac+Cis+Gem16.4

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Progression-Free Survival

Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause. (NCT01893801)
Timeframe: Over the course of the subjects' treatment and participation in study, approx 18 mos

Interventionmonths (Median)
Nab-Pac+Cis+Gem10.1

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Percentage Change in CA 19-9

Percentage change in CA 19-9 from baseline values (NCT01893801)
Timeframe: Over the course of the subjects' treatment on study, approx 1 year

Interventionpercentage change CA 19-9 from baseline (Mean)
Nab-Pac+Cis+Gem-47.7

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Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)

"The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life (my swallowing impacts my day-to-day life). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning)." (NCT01898494)
Timeframe: Assessed at baseline

Interventionscore on a scale (Mean)
Arm S (Surgery) Then Arm A (Low Risk, Observation)89.1
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)90.2
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)87.4
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)88.2

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Progression-free Survival Rate at 2 Years

Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years. (NCT01898494)
Timeframe: Assessed every 3 months for 2 years

Interventionproportion of participants (Number)
Arm S (Surgery) Then Arm A (Low Risk, Observation)0.969
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)0.949
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)0.96
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)0.907

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Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)

"The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life (my swallowing impacts my day-to-day life). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning)." (NCT01898494)
Timeframe: Assessed 4-6 weeks after surgery

Interventionscore on a scale (Mean)
Arm S (Surgery) Then Arm A (Low Risk, Observation)75.5
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)76.3
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)69.6
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)73.3

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Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score

The FACT-H&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL. (NCT01898494)
Timeframe: Assessed at 6 months after treatment

Interventionscore on a scale (Mean)
Arm S (Surgery) Then Arm A (Low Risk, Observation)128.5
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)121.02
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)117.8
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)114.6

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Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins

"Surgery quality was evaluated based on grade 3-4 bleeding events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during surgery and positive margins after surgery. Per CTCAE v5.0, grade 3 = severe and grade 4 = life-threatening.~Having grade 3-4 bleeding or positive margins indicates worse outcomes." (NCT01898494)
Timeframe: Assessed during surgery and directly after surgery

Interventionproportion of participants (Number)
Arm S (Surgery)0.091

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Progression-Free Survival (PFS)

This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day. (NCT01907100)
Timeframe: From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)

,
InterventionMonths (Median)
Phase IIPhase III
Nintedanib9.366.77
Placebo5.726.97

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Overall Survival (OS)

"Overall survival was defined as the duration of time from randomization to time of death.~This is the key secondary endpoint of the trial." (NCT01907100)
Timeframe: From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)

,
InterventionMonths (Median)
Phase IIPhase III
Nintedanib18.3014.36
Placebo14.4616.07

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Objective Response According to Modified RECIST- Investigator Assessment

"Objective response (best overall tumour response of confirmed complete response [CR] or confirmed partial response [PR]).~Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement.~Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part." (NCT01907100)
Timeframe: Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months

InterventionPercentage of participants (Number)
Placebo42.8
Nintedanib45.0

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Disease Control According to Modified RECIST- Investigator Assessment

"Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST.~Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part." (NCT01907100)
Timeframe: Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months

InterventionPercentage of participants (Number)
Placebo92.6
Nintedanib90.8

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Number of Patients With Dose-limiting Toxicities Per NCI Common Terminology for Adverse Events (CTCAE) - (Phase Ib)

Number of patients with Grade 3 and 4 toxicities per NCI Common Terminology for Adverse Events (CTCAE) version 4.0 requirements. (NCT01918306)
Timeframe: During the first 4 weeks

Interventionparticipants (Number)
1PHIbA - Cisplatin and GDC-0941 Cohort 10
1 PHIbA - Arm 1 - Cisplatin and GDC-0941Cohort 21

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Percentage of Patients Achieving Overall Response - (Phase II)

"The primary efficacy endpoint is overall response rate (ORR) of cisplatin + GDC-0941 versus cisplatin alone in patients with AR- TN MBC. ORR is defined as the percentage of subjects achieving complete response (CR) plus partial response (PR) as their best response by RECIST version 1.1 for targeted lesions and assessed by CT, MRI scan.~Objective responses, was estimated by the overall tumor burden at baseline (targeted lesions) in which subsequent measurements were performed every 8 weeks using the Solid Tumor Response Criteria (RECIST) v1.1 were compared. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT01918306)
Timeframe: at 8 weeks

InterventionParticipants (Count of Participants)
2PHII1 Arm 1 Cisplatin0
2PHII2 Arm 2 - Cisplatin and GDC-09411
2PHIICO - Crossover to Arm 2 - Cisplatin and GDC-09410

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Time to Progression - (Phase II)

Time to Progression (TTP) is calculated with the corresponding 95% confidence interval at the dose recommended for phase II. TTP is defined as the time from randomization until objective tumor progression, this does not include deaths unrelated to disease progression. (NCT01918306)
Timeframe: From time of randomization to disease progression, up to 104 weeks

Interventiondays to progression (Median)
2PHII1 - Arm 1 - Cisplatin24.5
2PHII2 - Arm 2 - Cisplatin and GDC-0941NA
2PHIICO - Crossover to Arm 2 - Cistplatin + GDC - 094133

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Clinical Benefit Rate - (Phase II)

"Clinical Benefit Rate (CBR) is defined as complete response (CR) plus partial response (PR) plus stable disease (SD) for 6 months.~Clinical Benefit Rate (CBR) is calculated with the corresponding 95% confidence intervals at the dose recommended for phase II.~Response and progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 performed at baseline and every 8 weeks will be compared." (NCT01918306)
Timeframe: at 32 weeks

Intervention ()
2 PHII1 - ARM 1 Cisplatin0
2PHII2 - ARM 2 - Cisplatin and GDC-09410
2PHIICO - Crossover to 2 - Cisplatin + GDC-09410

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Percent of Patients With Pathologic Complete Response (Phase II)

The study will follow an optimal two-stage Simon design based on pathologic complete response rate. (NCT01938573)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Sirolimus, Cisplatin, Gemcitabine4

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Patients With Dose Limiting Toxicity

Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline). (NCT01938573)
Timeframe: Up to 28 days

InterventionParticipants (Count of Participants)
Phase 1 - Sirolimus, Cisplatin, Gemcitabine0

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Positive Predictive Value (PPV) of HRD Score

"Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.~PPV was calculated as the probability of pathological response among the HRD positive group." (NCT01982448)
Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Interventionprobability (Number)
Arm A: Cisplatin.231
Arm B: Paclitaxel.286

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Number of Participants With Pathologic Response by HR-deficiency (HRD) Status

Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33. (NCT01982448)
Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

,,,
InterventionParticipants (Count of Participants)
Responder (RCB-0/1)Non-Responder (RCB-2/3 or crossover)
Arm A: Cisplatin With HRD-215
Arm A: Cisplatin With HRD+930
Arm B: Paclitaxel With HRD-49
Arm B: Paclitaxel With HRD+1025

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Provocative Concentration (PC20) After Methacholine Challenge

The provocative concentration (PC) of inhaled methacholine required to reduce forced expiratory volume in 1 second (FEV1) by 20% (PC20) was calculated from the methacholine challenge at screening and 2 hours (+15 minutes) post dose on Day 3 of each Treatment Period using a five-breath dosimeter method. The primary endpoint was the methacholine PC20 value normalized by means of a log (base 2) transformation, at 2 dose levels compared with placebo in participants with asthma following provocation with methacholine. (NCT01993329)
Timeframe: Screening (Day -21 to Day -1) and Day 3

Interventionlog [mg/mL] (Geometric Mean)
Gefapixant 500.91
Gefapixant 3000.84
Placebo0.82

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Highest FEV1 After Methacholine Challenge

Serial FEV1 was measured post inhalation of methacholine challenges for 90 minutes. The highest FEV1 at 5, 15, 30, 45, 60, and 90 minutes following methacholine challenge were evaluated for each subject. The minimum highest FEV1 was derived using the first three available measures that cover the first 30 minutes after the challenge. (NCT01993329)
Timeframe: Screening (Day -21 to Day -1) and Day 3

,,,
InterventionLiters (Mean)
+ 5 minutes+15 minutes+30 minutes+45 minutes+60 minutes+90 minutesMinimum Highest FEV1
Gefapixant 3002.432.672.832.993.063.122.43
Gefapixant 502.532.722.933.023.113.152.53
Placebo2.542.772.943.033.143.182.54
Screening2.442.692.862.932.993.102.44

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Participants With Adverse Events

(NCT02000531)
Timeframe: start of second-line treatment to data cut-off in December 2014 (within 12 months)

,
Interventionparticipants (Number)
With any adverse events (AEs)With any serious AEs (SAEs)With any AEs Grade ≥ 3With any drug related (possible/probable) AEsWith any drug related (possible/probable) SAEsWith any AEs leading to study drug withdrawalWith any AEs leading to deathWith AEs of Special InterestWith pregnancy
Chemotherapy-Erlotinib1212900000
Erlotinib-Chemotherapy14051000000

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Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events

Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment. (NCT02000531)
Timeframe: within 3 years, 9 months (data cut-off December 2014)

InterventionMonths (Median)
Erlotinib-Chemotherapy26.3
Chemotherapy-Erlotinib23.4

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Clinical Benefit Rate

The clinical benefit rate is the percentage of patients with an objective response or stable disease (SD). SD is defined as not meeting criteria of complete response and partial response, in absence of meeting criteria for disease progression. Follow-up measurements must have met the SD criteria at least once after randomization at a minimum interval of 8 weeks. (NCT02052960)
Timeframe: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.

InterventionParticipants (Count of Participants)
CetuGEX88
Cetuximab94

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Objective Response Rate (ORR)

"Objective response rate is the percentage of patients with a tumor size reduction of a predefined amount for a minimum time period and it is defined as the sum of complete responses (CR) and partial responses (PR).~CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).~PR: At least a 30% decrease in the tumor burden (sum of the longest lesion diameter (LD) of target lesions (including the short axes of any target lymph nodes plus measurable new lesions), taking as reference the baseline sum diameters." (NCT02052960)
Timeframe: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.

InterventionParticipants (Count of Participants)
CetuGEX52
Cetuximab57

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Overall Survival

The overall survival is defined as the duration of time from randomization to the time of death. (NCT02052960)
Timeframe: Time from randomization to the time of death, up to 24 month.

Interventionweeks (Median)
CetuGEX49.7
Cetuximab59.0

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Progression-free Survival (PFS)

The primary efficacy endpoint was PFS as assessed by the investigator. Date of disease progression was defined as the date of imaging (based on computed tomography (CT) scans or magnetic resonance imaging (MRI)) showing disease progression, as assessed by the investigator according to adapted immune-related RECIST 1.1 (modified irRC). Disease progression was defined as a 20% increase in tumor burden, taking as reference the smallest tumor burden recorded since the treatment started; confirmation by a second scan was not required. The PFS time was censored at the time of the last tumor assessment if the patient was alive and without progression at the last time of observation. (NCT02052960)
Timeframe: The PFS was defined as time from randomization until disease progression or death of any cause, up to 24 month

Interventionweeks (Median)
CetuGEX27.7
Cetuximab26.4

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Time of Global Health Status Deterioration

"Quality of Life (QoL) scores as assessed by European Oncology Research Trials Committee (EORTC) QoL questionnaires (QLQ) EORTC-QLQ-C30.~Scores are on a scale of 0 to 100, where 100 represents the highest possible QoL.Time to first deterioration of at least 10 points." (NCT02052960)
Timeframe: From randomization up to end-of study visit, up to 24 month

Interventionweeks (Median)
CetuGEX in Combination With Chemotherapy43.4
Cetuximab in Combination With Chemotherapy31.3

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Time to Treatment Failure

Time to treatment failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death. (NCT02052960)
Timeframe: Time to treatment failure, defined as the interval between the date of randomization and the date of treatment discontinuation for any reason, up to 24 month.

Interventionweeks (Median)
CetuGEX22.1
Cetuximab23.3

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. (NCT02082522)
Timeframe: Baseline, 16 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC-6.7
Standard Medical Care (SMC)3.3

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. (NCT02082522)
Timeframe: Baseline, 13 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC0.0
Standard Medical Care (SMC)2.5

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Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)

From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors) (NCT02082522)
Timeframe: Up to 26 months

Interventionpercentage of participants (Number)
Photodynamic Therapy-Photofrin Plus SMC56
Standard Medical Care (SMC)75

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Overall Survival Time

Time from the date of randomization until the date of death or the last date the subject was known to be alive (NCT02082522)
Timeframe: Up to 26 months

Interventiondays (Median)
Photodynamic Therapy-Photofrin Plus SMC444
Standard Medical Care (SMC)387

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Change From Baseline on Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 7 days

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC-0.7
Standard Medical Care (SMC)0

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 54 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC0.0
Standard Medical Care (SMC)0.0

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 41 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC10.0
Standard Medical Care (SMC)0.0

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 29 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC0.0
Standard Medical Care (SMC)2.0

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. (NCT02082522)
Timeframe: Baseline, up to 4 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC1.7
Standard Medical Care (SMC)0

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Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death

An adverse event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the first trial treatment given (Sym004 or one of the individual Platinum-Doublet therapies) or if they worsened after receiving first dose of treatment. (NCT02083679)
Timeframe: Day 1 up to 28 days after last dose of study drug (up to 53 weeks)

,,,
Interventionsubjects (Number)
TEAEsSerious TEAEsTEAE leading to DiscontinuationTEAEs Leading to Death
Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel3300
Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine3310
Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed6530
Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel3320

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Number of Subjects With Dose Limiting Toxicities (DLTs)

DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not >5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not >5 days; fatigue/headache lasting < 7 days; nausea/vomiting/diarrhoea lasting not >3 days; asymptomatic Grade 3 increase in liver function tests that resolve to baseline within 7 days; Mucositis >= Grade 3 lasting < 7 days; Grade 3 hyperglycemia that resolves in < 7 days; any laboratory values >Grade 3 without any clinical correlate (resolve within 5 days); Grade 3 skin toxicities that resolve to Grade 2 within 7 days; Grade 3/4 hypomagnesemia that resolves within 5 days. Subjects with DLTs presented based on investigator and SMC decision. (NCT02083679)
Timeframe: Day 1 to Day 21 of Cycle 1

,,,
InterventionSubjects (Number)
InvestigatorSMC
Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel10
Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine22
Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed11
Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel00

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Overall Survival (OS) From the First Laparoscopic HIPEC

Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after the first laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method. (NCT02092298)
Timeframe: From the day of surgery, until the last day of follow up, until death, up to 5 years

InterventionMonths (Median)
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)20.3

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Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy

Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration. Overall survival measured from time of laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method. (NCT02092298)
Timeframe: Between the second and sixth week after treatment, up to 5 years

InterventionMonths (Median)
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)30.2

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Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin

To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC. (NCT02127372)
Timeframe: After cycle 1, day 22

Interventionmg/m2 (Number)
DocetaxelCisplatin
Phase 16060

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Phase II - Radiographic Response

"The percentage of patients with a complete or partial response.~Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD." (NCT02127372)
Timeframe: After Cycle 6, approximately 18 weeks.

Interventionpercentage of participants (Number)
Phase 225

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Phase 2: 1 Year Survival

Phase II: Percentage of patients alive 1 year from the start of protocol treatment. (NCT02127372)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Phase 261

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Phase 1 - Maximum Tolerated Dose (MTD) of STI571

To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC. (NCT02127372)
Timeframe: After cycle 1, day 22

Interventionmg (Number)
Phase 1400

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The Remission Rate for Participants With High-risk Myeloma

Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy. (NCT02128230)
Timeframe: from baseline to either death or study completion for each subject (up to approximately 48 months)

InterventionParticipants (Number)
Total Therapy 5B0

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Overall Survival

Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model. (NCT02196168)
Timeframe: 12 months

Interventionmonths (Median)
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)0.21

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Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug (NCT02196168)
Timeframe: Up to 1 year

Interventionadverse events (Number)
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)13

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Levels of Pharmacodynamic Biomarkers

Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships. (NCT02196168)
Timeframe: Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4

Intervention ()
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)0
Arm II (Placebo, Cisplatin)0

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Levels of Predictive Biomarkers

Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships. (NCT02196168)
Timeframe: Up to day 4 of course 1

Intervention ()
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)0
Arm II (Placebo, Cisplatin)0

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Overall Response Rate (Complete Plus Partial Response) Using RECIST Criteria v1.1

Per Response Evaluation Criteria in solid Tumors (RECIST1.1) Target lesions are assessed as Complete Response(CR), Disappearance of all target lesions; Partial Response (PR),30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), At least a 20% increase (minimum 5 mm) from smallest sum (nadir); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Nontarget lesions are assessed as Complete Response (CR), Disappearance of all non-target lesions; Non-CR/Non-PD, Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; Progressive Disease (PD),Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Overall Response(OR); PR=CR+non-CR/non-PD,SD=SD+non-PD; PD=PD+presence of any non-target lesions (NCT02196168)
Timeframe: Up to 1 year

InterventionParticipants (Number)
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)0

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Progression Free Survival

Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model. (NCT02196168)
Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 months

Interventionmonths (Median)
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)2.88

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Progression Free Survival

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (20% increase in the sum of the longest diameter of target lesions or a measurable increase in a non-target lesion, or the appearance of new lesions) or death, whichever occurs first. (NCT02196168)
Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months

Interventionmonths (Median)
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)2.88

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Percentage of Participants With Grade 3+ Adverse Events

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. (NCT02254278)
Timeframe: End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT

,
Interventionpercentage of participants (Number)
End of RT1 month post-RT6 months post-RT1 year post-RT2 years post-RT
IMRT 5 Weeks (Arm 2)46.328.211.19.07.4
IMRT 6 Weeks + Cisplatin (Arm 1)73.736.117.914.08.6

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Percentage of Participants With Distant Metastasis

Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. (NCT02254278)
Timeframe: From randomization to 2 years

,
Interventionpercentage of participants (Number)
Six monthsTwo years
IMRT 5 Weeks02.1
IMRT 6 Weeks + Cisplatin04.0

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Percentage of Participants Alive

Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. (NCT02254278)
Timeframe: from randomization to 2 years

,
Interventionpercentage of participants (Number)
Six monthsTwo years
IMRT 5 Weeks98.097.3
IMRT 6 Weeks + Cisplatin99.396.7

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Percentage of Participants With Local-regional Failure

Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. (NCT02254278)
Timeframe: From randomization to 2 years

,
Interventionpercentage of participants (Number)
Six monthsTwo years
IMRT 5 Weeks2.09.5
IMRT 6 Weeks + Cisplatin0.73.3

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Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years

NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis. (NCT02254278)
Timeframe: 3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)

Interventionpercentage of participants (Number)
Progression-free SurvivalLocal-regional failure
Both Arms Combined92.094.5

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Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)

Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution. (NCT02254278)
Timeframe: From randomization to 2 years

Interventionpercentage of participants (Number)
IMRT 6 Weeks + Cisplatin (Arm 1)90.5
IMRT 5 Weeks (Arm 2)87.6

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Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)

The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia. (NCT02254278)
Timeframe: One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2

Interventionscore on a scale (Mean)
IMRT 6 Weeks + Cisplatin (Arm 1)85.3
IMRT 5 Weeks (Arm 2)81.8

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Number of Participants Post Operative/Radiation Therapy Complications

Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol. (NCT02256982)
Timeframe: 90 Days

Interventionparticipants (Number)
Resectable Disease0
Unresectable Disease0

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2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

The outcome measure will be reported as the proportion of patients with LRC at 2 years post-treatment. (NCT02281955)
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).

InterventionParticipants (Count of Participants)
De-escalated Radiation and Chemotherapy105

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2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

The outcome measure will be reported as the proportion of patients who are still alive (overall survival) at 2 years post-treatment. (NCT02281955)
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).

InterventionParticipants (Count of Participants)
De-escalated Radiation and Chemotherapy106

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2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

The outcome measure will be reported as the proportion of patients with RC at 2 years post-treatment. (NCT02281955)
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).

InterventionParticipants (Count of Participants)
De-escalated Radiation and Chemotherapy110

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2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Progression Free Survival (PFS) was defined as the time from the beginning of treatment to cancer progression or death. The outcome measure will be reported as the proportion of patients with PFS at 2 years post-treatment. (NCT02281955)
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks)

InterventionParticipants (Count of Participants)
De-escalated Radiation and Chemotherapy99

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2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

The outcome measure will be reported as the proportion of patients with DMFS at 2 years post-treatment. (NCT02281955)
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).

InterventionParticipants (Count of Participants)
De-escalated Radiation and Chemotherapy103

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2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

The outcome measure will be reported as the proportion of patients with LC at 2 years post-treatment. (NCT02281955)
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).

InterventionParticipants (Count of Participants)
De-escalated Radiation and Chemotherapy107

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Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events

Reportable adverse events will be tracked for 30 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events thought to be possibly, probably, or definitely related to MK-3475. Events thought to be probably or definitely related to surgery, adjuvant chemotherapy, or radiotherapy need not be recorded. (NCT02296684)
Timeframe: Through 30 days after last dose of MK-3475

,
InterventionParticipants (Count of Participants)
Grades 1-2 fatigue (neoadjuvant period)Grades 1-2 fever (neoadjuvant period)Grades 1-2 tumor flare (neoadjuvant period)Grades 1-2 AST increase (neoadjuvant period)Grades 1-2 ALT increase (neoadjuvant period)Grades 1-2 fatigue (adjuvant period)Grades 1-2 hypothyroidism (adjuvant period)Grades 3-4 hypothyroidism (adjuvant period)Grades 1-2 AST increase (adjuvant period)Grades 1-2 ALT increase (adjuvant period)Grades 1-2 alkaline phosphatase increase (adjuvant period)Grades 1-2 diarrhea (adjuvant period)
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475211002311111
Cohort 2: Neoadjuvant MK-3475300220000000

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Number of Surgical Complications and/or Delays in Cohorts 1 and 2

(NCT02296684)
Timeframe: At the time of surgery (approximately 2-3 weeks after registration)

InterventionParticipants (Count of Participants)
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-34755
Cohort 2: Neoadjuvant MK-34756

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Locoregional Recurrence Rates in Cohorts 1 and 2

-The percentage of participants who developed local-regional recurrence within one year of surgery (NCT02296684)
Timeframe: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)

InterventionParticipants (Count of Participants)
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-34752
Cohort 2: Neoadjuvant MK-34752

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Distant Failure Rate in Cohorts 1 and 2

-The percentage of participants who developed distant failure within one year of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed. (NCT02296684)
Timeframe: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)

InterventionParticipants (Count of Participants)
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-34753
Cohort 2: Neoadjuvant MK-34751

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Rate of Major Pathologic Treatment Effect in Cohort 1

"Major pathologic treatment effect=pathologic tumor response (pTR).~pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (>10%), pTR-1 (10-49%), and pTR-2 (≥50%)." (NCT02296684)
Timeframe: At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)

InterventionParticipants (Count of Participants)
pTR-0pTR-1pTR-2
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-34752088

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Rate of Major Pathologic Treatment Effect in Cohort 2

"Major pathologic treatment effect=pathologic tumor response (pTR).~pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (>10%), pTR-1 (10-49%), and pTR-2 (≥50%)." (NCT02296684)
Timeframe: At the time of surgery (surgery occurred within 13-22 days after last neoadjuvant MK-3475 dose)

InterventionParticipants (Count of Participants)
pTR-0pTR-1pTR-2
Cohort 2: Neoadjuvant MK-347513213

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Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)

Dose Expansion. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (NCT02300610)
Timeframe: Up to 6 months

,,
InterventionParticipants (Count of Participants)
Partial ResponseProgressive DiseaseStable DiseaseComplete ResponseNot Evaluable
Dose Escalation: Level 1 Dose01101
Dose Escalation: Level 2 Dose30000
Dose Expansion10111

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Progression Free Survival (PFS)

Dose Expansion. PFS is defined as the time from randomization until objective tumor progression or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT02300610)
Timeframe: 14 months

Interventionmonths (Median)
Dose Escalation: Level 1 Dose3.81
Dose Escalation: Level 2 Dose14.63
Dose Expansion7.68

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Overall Survival (OS)

Dose Expansion. Overall survival is defined as the time from randomization until death from any cause, and is measured in the intent-to-treat population. (NCT02300610)
Timeframe: Up to 24 Months

Interventionmonths (Median)
Dose Escalation: Level 1 Dose4.14
Dose Escalation: Level 2 Dose14.63
Dose Expansion10.03

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Overall Survival

2 year overall survival (NCT02325401)
Timeframe: 24 months

Interventionparticipants (Number)
Metformin (2000mg) With Chemoradiation5
Metformin (2550mg) With Chemoradiation8
Metformin (3000mg) With Chemoradiation4

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Progression Free Survival

2-year progression free survival (NCT02325401)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Metformin (2000mg) With Chemoradiation6
Metformin (2550mg) With Chemoradiation8
Metformin (3000mg) With Chemoradiation4

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Number of Participants With Adverse Events

Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.Any participants with any adverse event at any grade was included. Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks. (NCT02325401)
Timeframe: 36 months

InterventionParticipants (Count of Participants)
Metformin (2000mg) With Chemoradiation6
Metformin (2550mg) With Chemoradiation7
Metformin (3000mg) With Chemoradiation4

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Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation

Cohorts of patients received escalating doses of metformin (2000 mg, 2550 mg, or 3000 mg divided into daily doses) with a 7-day to 14-day lead-in prior to CRT based on the modified toxicity probability interval design to allow for possible re-escalation after previous de-escalation and to maximize the ability to identify the maximum tolerated dose (MTD). Patients continued to receive metformin for the duration of CRT as tolerated. (NCT02325401)
Timeframe: 24 months

Interventionmg (Number)
Metformin (2000mg) With ChemoradiationNA
Metformin (2550mg) With ChemoradiationNA
Metformin (3000mg) With ChemoradiationNA

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Number of Participants Experiencing No-Reoccurrence at 36 Months

Patients were evaulated at 36 months to determine if there was recurrence of disease. (NCT02325401)
Timeframe: 36 months

InterventionParticipants (Count of Participants)
Metformin (2000mg) With Chemoradiation6
Metformin (2550mg) With Chemoradiation8
Metformin (3000mg) With Chemoradiation4

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The Number of Patients With Tumor Size Reduction (Objective Response Rate)

Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT02358863)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Chemotherapy0

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Number of Participants With Treatment Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1.14) for target lesions and assessed by MRI: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02392637)
Timeframe: Up to 2 years

,
InterventionParticipants (Count of Participants)
Disease Control Rate(DCR)Complete Response(CR)Partial Response (PR)Stable Disease(SD)Progressive Disease(PD)Unknown
High Dose250141134
Low Dose1809955

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Median Progression Free Survival (PFS)

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT02392637)
Timeframe: up to 3 years

Interventionmonths (Median)
High Dosage11.4
Low Dosage14.9

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Median Overall Survival (OS)

The Kaplan-Meier method was used to estimate OS, with surviving patients censored at the time of surgery or at last known follow-up. (NCT02392637)
Timeframe: up to 3 years

Interventionmonths (Median)
High Dose19.5
Low Dose15.7

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Proportion of Patients With Renal Insufficiency at Completion of Surgery

Renal insufficiency is defined as CrCl < 60 ml/min. (NCT02412670)
Timeframe: Assessed at completion of surgery (21-60 days from completion of chemotherapy; chemotherapy was administered for a total of 4 cycles; cycle length is 14 days and 21 days for arms A and B, respectively)

Interventionproportion of participants (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.69
Arm B (Gemcitabine, Carboplatin)0.833

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Proportion of Patients With Renal Insufficiency at Completion of Chemotherapy

Renal insufficiency is defined as CrCl < 60 ml/min. (NCT02412670)
Timeframe: Assessed at completion of chemotherapy; at 8 weeks for Arm A and 12 weeks for Arm B

Interventionproportion of participants (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.2
Arm B (Gemcitabine, Carboplatin)0.833

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Event-free Survival

Event-free survival is defined as the time from registration to the earliest occurrence of recurrence of any type, disease progression, new invasive primary cancer, or death from any cause. Disease progression will be assessed using RECIST 1.1. Disease progression is defined as appearance of one or more new lesions, unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years, and every 6 months for 3-5 years

Interventionmonths (Median)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)NA
Arm B (Gemcitabine, Carboplatin)10.2

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Cumulative Incidence of Cancer-specific Death at 24 Months

Cancer-specific survival was defined as the time from registration to death due to cancer; deaths due to other causes are counted as competing events. Cancer-specific survival was analyzed using Gray's method and cumulative incidence of cancer-specific death at 24 months is reported. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years

Interventionproportion of patients died of cancer (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.09
Arm B (Gemcitabine, Carboplatin)0.20

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Complete Pathologic Response Rate

Complete pathologic response is defined as pT0pN0 (no evidence of disease) as assessed by pathologic evaluation of nephrectomy/ureterectomy and any identifiable regional lymph nodes. (NCT02412670)
Timeframe: Assessed at nephroureterectomy or regional lymph node dissection (21-60 days from completion of chemotherapy; chemotherapy was administered for a total of 4 cycles; cycle length is 14 days and 21 days for arms A and B, respectively)

Interventionproportion of participants (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.103
Arm B (Gemcitabine, Carboplatin)0.167

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Recurrence-free Survival

Recurrence-free survival is defined as the time from the date of surgery to disease recurrence or death from any cause. Patients alive without documented recurrence will be censored at the date of last disease assessment. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years; and every 6 months for 3-5 years

Interventionmonths (Median)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)NA
Arm B (Gemcitabine, Carboplatin)8.5

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Bladder Cancer-free Survival

Bladder cancer-free survival was defined as the time from the date of surgery to the earlier of a return of bladder cancer or death from any cause. Patients alive without documented bladder cancer were censored at the date of last disease assessment. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years, and every 6 months for 3-5 years

Interventionmonths (Median)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)NA
Arm B (Gemcitabine, Carboplatin)NA

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Proportion of Basal Subtype

Proportion of basal subtype was calculated as number of patients who had basal subtype disease divided by all triple-negative breast cancers who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype results. (NCT02445391)
Timeframe: Assessed at registration to step 0 (baseline)

Interventionpercentage of participants (Number)
All Patients Concurrently Randomized to Arms B and C78

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3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients

RFS was defined as time from randomization to local/regional recurrence, distant recurrence or death, whichever occurred first. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of RFS events. 3-year RFS rate was estimated using Kaplan-Meier method. (NCT02445391)
Timeframe: No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.

Interventionpercentage of participants (Number)
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)46.2
Arm C (Capecitabine) (Open to Accrual 6/22/2016)49.3

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3-year Overall Survival (OS) Rate in Basal-Subtype Patients

OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method. (NCT02445391)
Timeframe: Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years

Interventionpercentage of participants (Number)
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)57.8
Arm C (Capecitabine) (Open to Accrual 6/22/2016)66.2

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3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients

IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method. (NCT02445391)
Timeframe: No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.

Interventionpercentage of participants (Number)
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)42.0
Arm C (Capecitabine) (Open to Accrual 6/22/2016)49.4

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Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab

Blood samples were collected to determine the Cmax_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Within 1 hour after end of infusion on infusion day at Week 12.

Interventionmcg/mL (Mean)
Durvalumab Monotherapy625.3
Durvalumab + Tremelimumab506.1

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Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population

The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab MonotherapyNA
Durvalumab + TremelimumabNA
SoC Chemotherapy4.4

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DoR; PD-L1 (TC >=1%) Analysis Set Population

The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab MonotherapyNA
Durvalumab + TremelimumabNA
SoC Chemotherapy4.4

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DoR; FAS Population

The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab MonotherapyNA
Durvalumab + TremelimumabNA
SoC Chemotherapy4.3

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Ctrough_ss of Tremelimumab

Blood samples were collected to determine the Ctrough_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Pre-dose at Week 12.

Interventionmcg/mL (Mean)
Durvalumab + Tremelimumab4.9

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Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab

Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against durvalumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02453282)
Timeframe: At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.

,
InterventionParticipants (Count of Participants)
ADA positive at any timeTreatment-emergent ADA positiveADA positive at baseline and post-baselineADA positive at post-baseline onlyADA positive at baseline onlyTreatment-boosted ADAPersistent positiveTransient positivenAb positive at any visit
Durvalumab + Tremelimumab1481850901
Durvalumab Monotherapy1783860832

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Serum Concentrations of Durvalumab

Blood samples were collected to determine the serum concentration of durvalumab. (NCT02453282)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, and at follow-up Month 3.

,
Interventionmicrogram per milliliter (mcg/mL) (Mean)
At Week 0: Pre-infusionAt Week 0: End of infusionAt Week 12: Pre-infusionAt Week 12: End of infusionAt Week 24: Pre-infusionAt Week 24: End of infusionAt follow-up Month 3
Durvalumab + TremelimumabNA444.3140.8506.1197.0553.241.4
Durvalumab MonotherapyNA484.5139.5625.3163.0598.249.3

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Serum Concentrations of Tremelimumab

Blood samples were collected to determine the serum concentration of tremelimumab. (NCT02453282)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3.

Interventionmcg/mL (Mean)
At Week 0: Pre-infusionAt Week 0: End of infusionAt Week 12: Pre-infusionAt Week 12: End of infusionAt follow-up Month 3
Durvalumab + TremelimumabNA22.64.924.80.5

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Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population

The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of Complete Response (CR) or Partial Response (PR). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionpercentage of participants (Number)
Durvalumab Monotherapy35.6
Durvalumab + Tremelimumab34.4
SoC Chemotherapy37.7

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Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy

The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab + Tremelimumab3.9
SoC Chemotherapy5.4

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PFS2; PD-L1 (TC >=1%) Analysis Set Population

The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy10.6
Durvalumab + Tremelimumab9.4
SoC Chemotherapy10.5

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Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Interventionpercentage of participants (Number)
Durvalumab Monotherapy27.0
Durvalumab + Tremelimumab20.4
SoC Chemotherapy14.9

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Percentage of Participants APF12; FAS Population

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Interventionpercentage of participants (Number)
Durvalumab Monotherapy22.5
Durvalumab + Tremelimumab19.8
SoC Chemotherapy13.8

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Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Interventionpercentage of participants (Number)
Durvalumab Monotherapy32.3
Durvalumab + Tremelimumab25.8
SoC Chemotherapy14.3

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Cmax_ss of Tremelimumab

Blood samples were collected to determine the Cmax_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Within 1 hour after end of infusion on infusion day at Week 12.

Interventionmcg/mL (Mean)
Durvalumab + Tremelimumab24.8

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Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy16.3
Durvalumab + Tremelimumab11.9
SoC Chemotherapy12.9

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Number of Participants With ADA Response to Tremelimumab

Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against tremelimumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02453282)
Timeframe: At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.

InterventionParticipants (Count of Participants)
ADA positive at any timeTreatment-emergent ADA positiveADA positive at baseline and post-baselineADA positive at post-baseline onlyADA positive at baseline onlyTreatment-boosted ADAPersistent positiveTransient positivenAb positive at any visit
Durvalumab + Tremelimumab33281284025425

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Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab

Blood samples were collected to determine the Ctrough_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Pre-dose at Week 12.

Interventionmcg/mL (Mean)
Durvalumab Monotherapy139.5
Durvalumab + Tremelimumab140.8

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Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population

The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy12.7
Durvalumab + Tremelimumab10.9
SoC Chemotherapy10.4

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PFS2; FAS Population

The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy9.3
Durvalumab + Tremelimumab9.8
SoC Chemotherapy10.1

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OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy16.3
Durvalumab + Tremelimumab11.9
SoC Chemotherapy12.9

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OS; PD-L1 (TC >=1%) Analysis Set Population

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy14.6
Durvalumab + Tremelimumab10.9
SoC Chemotherapy12.3

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PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy

The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy4.7
Durvalumab + Tremelimumab3.9
SoC Chemotherapy5.4

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PFS; PD-L1 (TC >=1%) Analysis Set Population

The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy3.6
Durvalumab + Tremelimumab2.8
SoC Chemotherapy5.5

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OS; FAS Population

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy12.3
Durvalumab + Tremelimumab11.2
SoC Chemotherapy11.8

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ORR; PD-L1 (TC >=1%) Analysis Set Population

The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionpercentage of participants (Number)
Durvalumab Monotherapy26.5
Durvalumab + Tremelimumab25.3
SoC Chemotherapy33.6

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ORR; FAS Population

The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionpercentage of participants (Number)
Durvalumab Monotherapy22.2
Durvalumab + Tremelimumab24.7
SoC Chemotherapy30.1

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PFS; FAS Population

The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy2.8
Durvalumab + Tremelimumab2.9
SoC Chemotherapy5.4

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DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
PD-L1-negative NSCLC analysis setFAS
China: Durvalumab + Tremelimumab10.512.9
China: SoC Chemotherapy6.16.1
Global: Durvalumab + Tremelimumab10.211.1
Global: SoC Chemotherapy4.94.9

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APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

,,,
Interventionpercentage of participants (Number)
PD-L1-negative NSCLC analysis setFAS
China: Durvalumab + Tremelimumab15.623.9
China: SoC Chemotherapy11.316.6
Global: Durvalumab + Tremelimumab18.220.2
Global: SoC Chemotherapy12.114.9

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Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"The APF12 was defined as the percentage of participants who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

,
Interventionpercentage of participants (Number)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab25.622.021.6
Global: SoC Chemotherapy7.012.313.8

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Serum Concentrations of Durvalumab

Blood samples were collected to determine the serum concentration of durvalumab. (NCT02542293)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12; pre-dose on Week 24 and at follow-up Month 3

,
Interventionmicrogram per milliliter (µg/mL) (Geometric Mean)
Week 0: Pre-infusionWeek 0: End of infusionWeek 12: Pre-infusionWeek 12: End of infusionWeek 24: Pre-infusionFollow-up Month 3
China: Durvalumab + TremelimumabNA392.772.4448.985.65.4
Global: Durvalumab + TremelimumabNA418.677.5434.3108.88.8

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OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets

"The OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on last recorded date on which participant was known to be alive.~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.~PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay." (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
FASPD-L1 TC ≥25% analysis setPD-L1 TC ≥50% analysis set
China: Durvalumab + Tremelimumab20.036.636.6
China: SoC Chemotherapy14.115.815.8
Global: Durvalumab + Tremelimumab10.912.214.1
Global: SoC Chemotherapy12.110.410.5

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OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).

Interventionmonths (Median)
China: Durvalumab + Tremelimumab15.0
China: SoC Chemotherapy11.7

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Serum Concentrations of Tremelimumab

Blood samples were collected to determine the serum concentration of tremelimumab. (NCT02542293)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3

,
Interventionµg/mL (Geometric Mean)
Week 0: Pre-infusionWeek 0: End of infusionWeek 12: Pre-infusionWeek 12: End of infusionFollow-up Month 3
China: Durvalumab + TremelimumabNA18.43.323.2NA
Global: Durvalumab + TremelimumabNA20.33.420.8NA

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Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab10.610.99.9
Global: SoC Chemotherapy8.610.59.0

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Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets

"The PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.~tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis settTMB ≥14 mut/Mb analysis settTMB ≥12 mut/Mb analysis settTMB ≥10 mut/Mb analysis settTMB ≥8 mut/Mb analysis set
Global: Durvalumab + Tremelimumab4.24.23.98.75.24.34.4
Global: SoC Chemotherapy5.15.55.15.85.85.15.0

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PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
PD-L1-negative NSCLC analysis setFAS
China: Durvalumab + Tremelimumab13.815.5
China: SoC Chemotherapy10.312.9
Global: Durvalumab + Tremelimumab9.19.4
Global: SoC Chemotherapy12.410.4

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PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets

"PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective PD or death regardless of whether participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).~PD-L1-negative analysis set included subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: FAS included all randomized participants prior to end of global recruitment.~China Cohort: China FAS included all randomized participants in China cohort and were used for all China only efficacy analyses.~PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included subset of participants in FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
PD-L1-negative NSCLC analysis setFASPD-L1 TC ≥25% analysis setPD-L1 TC ≥50% analysis set
China: Durvalumab + Tremelimumab5.14.26.86.8
China: SoC Chemotherapy6.06.05.75.7
Global: Durvalumab + Tremelimumab4.14.04.24.6
Global: SoC Chemotherapy5.65.65.45.4

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OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets

"OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at time of analysis was censored based on last recorded date on which participant was known to be alive.~bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb and bTMB <20 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥16 mut/Mb, ≥12 mut/Mb and <20 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~bTMB non-evaluable analysis set included the subset of participants in FAS whose bTMB status at baseline could not be determined by the GuardantOMNI CDx assay or whose sample was not available.~tTMB analysis sets are defined same as the bTMB analysis sets (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis setPD-L1 negative analysis setbTMB <20 mut/Mb analysis setbTMB non-evaluable analysis settTMB ≥14 mut/Mb analysis settTMB ≥12 mut/Mb analysis settTMB ≥10 mut/Mb analysis settTMB ≥8 mut/Mb analysis set
Global: Durvalumab + Tremelimumab12.110.911.19.99.317.511.111.111.0
Global: SoC Chemotherapy11.910.312.511.510.410.613.910.610.2

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OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Months 12, 18 and 24

,
Interventionpercentage of participants (Number)
Month 12: bTMB ≥20 mut/Mb analysis setMonth 12: bTMB ≥16 mut/Mb analysis setMonth 12: bTMB ≥12 mut/Mb analysis setMonth 18: bTMB ≥20 mut/Mb analysis setMonth 18: bTMB ≥16 mut/Mb analysis setMonth 18: bTMB ≥12 mut/Mb analysis setMonth 24: bTMB ≥20 mut/Mb analysis setMonth 24: bTMB ≥16 mut/Mb analysis setMonth 24: bTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab49.350.546.936.235.529.426.124.021.3
Global: SoC Chemotherapy40.848.944.620.428.527.813.618.219.0

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OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Months 12, 18 and 24

,,,
Interventionpercentage of participants (Number)
Month 12: PD-L1-negative NSCLC analysis setMonth 12: FASMonth 18: PD-L1-negative NSCLC analysis setMonth 18: FASMonth 24: PD-L1-negative NSCLC analysis setMonth 24: FAS
China: Durvalumab + Tremelimumab68.072.844.054.636.044.2
China: SoC Chemotherapy46.453.139.341.817.930.4
Global: Durvalumab + Tremelimumab47.847.734.134.822.125.7
Global: SoC Chemotherapy52.850.034.534.622.323.4

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ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets

"The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD.~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.~PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionpercentage of participants (Number)
PD-L1-negative NSCLC analysis setFASPD-L1 TC ≥25% analysis setPD-L1 TC ≥50% analysis set
China: Durvalumab + Tremelimumab23.135.954.860.0
China: SoC Chemotherapy41.439.040.646.4
Global: Durvalumab + Tremelimumab23.125.935.237.4
Global: SoC Chemotherapy38.841.743.944.0

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Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets

"The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) prior to PD.~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.~tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionpercentage of participants (Number)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis settTMB ≥14 mut/Mb analysis settTMB ≥12 mut/Mb analysis settTMB ≥10 mut/Mb analysis settTMB ≥8 mut/Mb analysis set
Global: Durvalumab + Tremelimumab27.531.228.761.342.637.736.7
Global: SoC Chemotherapy43.346.142.044.741.842.541.2

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Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab

Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to >=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02542293)
Timeframe: At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.

,
InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (positive post-baseline only)ADA positive post-baseline and positive at baselinePersistent positiveTransient positivenAb positive at any visitADA positive at baseline and not detected post-baseline
China: Durvalumab + Tremelimumab110101000
Global: Durvalumab + Tremelimumab26120121112313

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Number of Participants With ADA Response to Tremelimumab

Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to >=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02542293)
Timeframe: At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.

,
InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (positive post-baseline only)ADA positive post-baseline and positive at baselinePersistent positiveTransient positivenAb positive at any visitADA positive at baseline and not detected post-baseline
China: Durvalumab + Tremelimumab210110200
Global: Durvalumab + Tremelimumab493713642911339

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Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab11.610.611.5
Global: SoC Chemotherapy4.24.34.3

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Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).

Interventionmonths (Median)
Global: Durvalumab + Tremelimumab11.7
Global: SoC Chemotherapy9.1

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Treatment Limiting Adverse Events

Adverse events that were fatal or led to treatment discontinuation. (NCT02567409)
Timeframe: Assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months.

,
InterventionParticipants (Count of Participants)
HypotensionMulti-organ failureCardiac arrestNeutropeniaRespiratory failurePulmonary embolismThrombocytopeniaCreatinine IncreasedLeukocytosisAcute kidney injuryVomitingUrinary tract infection
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)001211211101
Arm B (Gemcitabine Hydrochloride, Cisplatin)110001220010

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Progression-free Survival (PFS)

Estimated using the product-limit method of Kaplan and Meier. Event defined as progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02567409)
Timeframe: Day of randomization, until progression, or death, assessed up to 12 months

InterventionMonths (Median)
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)8.0
Arm B (Gemcitabine Hydrochloride, Cisplatin)8.0

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Overall Survival (OS)

Estimated using the product-limit method of Kaplan and Meier. Event defined as death from any cause. (NCT02567409)
Timeframe: Up to 36 months

InterventionMonths (Median)
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)14.4
Arm B (Gemcitabine Hydrochloride, Cisplatin)19.8

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Confirmed Objective Response Rate

Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmed Objective Response = CR + PR. (NCT02567409)
Timeframe: Up to 36 months

Interventionpercentage of participants (Number)
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)54
Arm B (Gemcitabine Hydrochloride, Cisplatin)63

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Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site

"Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ENT physician's clinical exam note.~Partial response - 99-50% decrease" (NCT02573493)
Timeframe: Completion of 2 cycles (approximately 6 weeks)

InterventionParticipants (Count of Participants)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT11
Arm 2: Nab-Paclitaxel (A) + CRT28
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT6

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Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)

DFS: duration of time from last date of treatment to time of disease progression or death from any cause. (NCT02573493)
Timeframe: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)

Interventionpercentage of participants (Number)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT87.50
Arm 2: Nab-Paclitaxel (A) + CRT51.81
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT69.23

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Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)

DFS: duration of time from last date of treatment to time of disease progression or death from any cause. (NCT02573493)
Timeframe: Through one year after completion of treatment (approximately 74 weeks)

Interventionpercentage of participants (Number)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT87.50
Arm 2: Nab-Paclitaxel (A) + CRT62.50
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT76.92

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Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)

OS: duration of time from date of diagnosis to last date alive or time of death from any cause. (NCT02573493)
Timeframe: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)

Interventionpercentage of participants (Number)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT97.44
Arm 2: Nab-Paclitaxel (A) + CRT69.63
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT84.62

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Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)

â—¦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first. (NCT02573493)
Timeframe: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)

Interventionpercentage of participants (Number)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT87.43
Arm 2: Nab-Paclitaxel (A) + CRT54.89
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT69.23

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Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)

â—¦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first. (NCT02573493)
Timeframe: Through one year after completion of treatment (approximately 74 weeks)

Interventionpercentage of participants (Number)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT92.50
Arm 2: Nab-Paclitaxel (A) + CRT67.50
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT76.92

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Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Compare to those observed with APF with the objective that Arm 1 will be at least 25% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 30%) and Arm 2 will be at least 50% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 20%). (NCT02573493)
Timeframe: 30 days after completion of treatment (estimated to be 15-25 weeks)

InterventionParticipants (Count of Participants)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction23
Arm 2: Nab-Paclitaxel (A) Induction17
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction4
Arm 1 CRT: Cisplatin + Radiation Therapy37
Arm 1 & 2 ERT: Cetuximab + Radiation Therapy35
Arm 3 CR: Cisplatin + Radiation Therapy4

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Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1

(NCT02573493)
Timeframe: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)

Interventionkilograms (Median)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT8.4
Arm 2: Nab-Paclitaxel (A) + CRT5.2
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT7.0

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Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1

(NCT02573493)
Timeframe: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)

Interventionmedian percent of weight loss (Median)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT9.1
Arm 2: Nab-Paclitaxel (A) + CRT6.6
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT6.7

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Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria

-Computed tomography (CT) scan (intravenous contrast preferred) to document and measure the extent of the primary tumor size and involved regional neck nodes. RECIST 1.1 will be used to determine response at the primary tumor site, at the involved regional neck nodes and the radiographic overall tumor response. (NCT02573493)
Timeframe: Completion of 2 cycles (approximately 6 weeks)

,,
InterventionParticipants (Count of Participants)
Complete responsePartial response
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT222
Arm 2: Nab-Paclitaxel (A) + CRT120
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT113

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Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N

-The FACT-H&N has 5 domains with 39 items including physical well-being (PWB), social/family well being (SWB), emotional well-being (EWB), functional well-being (FWB), and head & neck cancer (HNCS) with answers ranging from 0 (Not at all) to 4 (Very Much). The PWB subscale score ranges from 0-28. The SWB subscale score ranges from 0-28. The EWB subscale score ranges from 0-24. The FWB subscale score ranges from 0-28. The HNCS subscale score ranges from 0-40. To obtain the total score all subscales are added together. The total score ranges from 0-148 with a higher score indicating a better quality of life. (NCT02573493)
Timeframe: Baseline and one year after completion of treatment (approximately 74 weeks)

,,
Interventionscore on a scale (Mean)
BaselineEnd of treatment
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT2.021.98
Arm 2: Nab-Paclitaxel (A) + CRT1.861.82
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT2.072.00

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Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4

-The FACT/GOG-NTX-4 questionnaire has 4 questions about neuropathy (numbness/tingling in hands/feet and discomfort in hands/feet) with answers ranging from 0 (Not at all) to 4 (Very Much). The total score ranges from 0 to 16. A lower score indicates less neuropathy symptoms. (NCT02573493)
Timeframe: Baseline and one year after completion of treatment (approximately 74 weeks)

,,
Interventionscore on a scale (Mean)
BaselineEnd of treatment
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT0.191.55
Arm 2: Nab-Paclitaxel (A) + CRT0.380.91
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT0.271.54

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Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site

"Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note.~Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality" (NCT02573493)
Timeframe: Completion of 2 cycles (approximately 6 weeks)

InterventionParticipants (Count of Participants)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT28
Arm 2: Nab-Paclitaxel (A) + CRT8

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Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)

OS: duration of time from date of diagnosis to late date alive or time of death from any cause. (NCT02573493)
Timeframe: Through one year after completion of treatment (approximately 74 weeks)

Interventionpercentage of particpants (Number)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT100
Arm 2: Nab-Paclitaxel (A) + CRT87.50
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT92.31

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Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events

(NCT02573493)
Timeframe: 30 days after completion of treatment (estimated to be 15-25 weeks)

InterventionParticipants (Count of Participants)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction23
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction4
Arm 1 CRT: Cisplatin + Radiation Therapy37
Arm 3 CR: Cisplatin + Radiation Therapy4

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Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site

"Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note.~Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality" (NCT02573493)
Timeframe: Completion of 2 cycles (approximately 6 weeks)

InterventionParticipants (Count of Participants)
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT9

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Arm 3: Median Percent Weight Loss

(NCT02573493)
Timeframe: Completion of treatment (estimated to be 11-15 weeks)

Interventionpercentage of weight loss (Median)
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT6.7

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Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes

"The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note.~Complete response - complete resolution - 100% decrease/minimal residual mucosal abnormality" (NCT02573493)
Timeframe: Completion of 2 cycles (approximately 6 weeks)

InterventionParticipants (Count of Participants)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT18
Arm 2: Nab-Paclitaxel (A) + CRT14
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT3

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Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes

"The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note.~Partial response - 99%-50% decrease" (NCT02573493)
Timeframe: Completion of 2 cycles (approximately 6 weeks)

InterventionParticipants (Count of Participants)
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT11
Arm 2: Nab-Paclitaxel (A) + CRT14
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT7

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Evaluation of the Efficacy of Pembrolizumab Given in Combination With Definitive CRT by Determining the Number of Participants With Complete Response at Treatment End (Day 150)

"Response was determined using a composite end point of overall end-of-treatment (EOT) complete response (CR) at day 150 (approximately 12 weeks after completion of chemoradiotherapy) by CT of the neck (RECIST 1.1).~Optional positron emission tomography (PET) imaging was allowed rather than neck dissection if CT could not confirm CR. Complete metabolic response was assessed using Hopkins score of 1, 2, or 3 on PET imaging. For those without an imaging CR, pathologic confirmation was recommend (but not required) by selective neck dissection and/or directed biopsy of the suspected active disease site. If pathologic evaluation of the potential disease site confirmed no residual invasive or in situ cancer, the patient was determined to have a pathologic CR. In cases with both an imaging CR and pathologic response assessment, the pathologic response defined final overall response. Therefore, patients with a final EOT CR included those with either an imaging (CT or PET) or pathologic CR." (NCT02586207)
Timeframe: Day 150 (post treatment imaging)

InterventionParticipants (Count of Participants)
Single Arm47

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Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.

"To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN).~Number of participants affected by AEs will be reported by grade and percentage of participants affected.~Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided." (NCT02586207)
Timeframe: through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment)

InterventionParticipants (Count of Participants)
Single Arm57

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Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2

Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. (NCT02659059)
Timeframe: From first dose to 30 days post last dose

InterventionParticipants (Count of Participants)
ALT OR AST >3XULNALT OR AST >5XULNALT OR AST >10XULNALT OR AST >20XULNTOTAL BILIRUBIN >2XULNConcurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 1 dayConcurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 30 days
Nivolumab+Ipilimumab+Chemotherapy2211000

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Progression Free Survival (PFS) - Part 1

Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT02659059)
Timeframe: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)

InterventionMonths (Median)
Nivolumab+Ipilimumab5.19

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Overall Survival (OS) - Part 2

Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. (NCT02659059)
Timeframe: From the date of first treatment to the date of death due to any cause (Up to approximately 59 months)

InterventionMonths (Median)
Nivolumab+Ipilimumab+Chemotherapy19.35

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Overall Survival (OS) - Part 1

Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive. (NCT02659059)
Timeframe: From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)

InterventionMonths (Median)
Nivolumab+Ipilimumab20.83

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Objective Response Rate (ORR) - Part 1

"Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT02659059)
Timeframe: From first dose up to approximately 72 months

InterventionPercentage of participants (Number)
Nivolumab+Ipilimumab32.3

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Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2

"Dose limiting toxicities (DLTs) were defined as any of the items listed below.~Any Grade 2 drug-related uveitis or eye pain that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment.~Any Grade 2 drug-related pneumonitis or interstitial lung disease that does not resolve to dose delay and systemic steroids in 14 days.~Any Grade 3 non-skin drug-related adverse event with the exception of laboratory abnormalities that cannot be alleviated or controlled by appropriate care within 14 days.~Any Grade 4 drug-related adverse event including laboratory abnormalities except Grade 4 leukopenia or neutropenia lasting < 14 days and asymptomatic amylase/lipase elevation.~Drug-related hepatic function laboratory abnormalities." (NCT02659059)
Timeframe: 9 weeks after first dose

InterventionParticipants (Count of Participants)
Nivolumab+Ipilimumab+Chemotherapy1

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Objective Response Rate (ORR) - Part 2

"Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT02659059)
Timeframe: From first dose up to approximately 59 months

InterventionPercentage of participants (Number)
Nivolumab+Ipilimumab+Chemotherapy47.2

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Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1

"Progression Free Survival (PFS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase" (NCT02659059)
Timeframe: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)

InterventionMonths (Median)
High TMB (>=10 Mutations/MB)Low TMB (<10 Mutations/MB)
Nivolumab+Ipilimumab10.842.79

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Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2

Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. (NCT02659059)
Timeframe: From first dose to 30 days post last dose

InterventionParticipants (Count of Participants)
TSH > ULNTSH > ULN with TSH <= ULN at baselineTSH > ULN with at least one FT3/FT4 test value < LLNTSH > ULN with all other FT3/FT4 test values ≥ LLNTSH > ULN with FT3/FT4 test missingTSH < LLNTSH < LLN with TSH >= LLN at baselineTSH < LLN with at least one FT3/FT4 test value > ULNTSH < LLN with all other FT3/FT4 test values <= ULNTSH < LLN with FT3/Ft4 test missing
Nivolumab+Ipilimumab+Chemotherapy1078111312760

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Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1

"Progression Free Survival (PFS) by PD-L1 expression levels was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells)" (NCT02659059)
Timeframe: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)

InterventionMonths (Median)
PD-L1 ≥1%PD-L1 <1%
Nivolumab+Ipilimumab6.802.92

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Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1

"Overall survival (OS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.~High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase" (NCT02659059)
Timeframe: From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)

InterventionMonths (Median)
High TMB (>=10 Mutations/MB)Low TMB (<10 Mutations/MB)
Nivolumab+Ipilimumab47.3111.33

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Overall Survival (OS) by PD-L1 Expression Levels - Part 1

"Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.~PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells)" (NCT02659059)
Timeframe: From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)

InterventionMonths (Median)
PD-L1 ≥1%PD-L1 <1%
Nivolumab+Ipilimumab26.5113.70

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Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1

"Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase" (NCT02659059)
Timeframe: From first dose up to approximately 72 months

InterventionPercentage of participants (Number)
High TMB (>=10 Mutations/MB)Low TMB (<10 Mutations/MB)
Nivolumab+Ipilimumab52.116.0

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Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1

Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 <1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. (NCT02659059)
Timeframe: From first dose to database lock (Up to 18 months)

InterventionPercentage of participants (Number)
PD-L1 ≥1%PD-L1 <1%
Nivolumab+Ipilimumab41.314.9

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Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1

"Objective response rate (ORR) by PD-L1 expression levels was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells)" (NCT02659059)
Timeframe: From first dose up to approximately 72 months

InterventionPercentage of participants (Number)
PD-L1 ≥1%PD-L1 <1%
Nivolumab+Ipilimumab44.217.1

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Number of Participants With Adverse Events (AEs) - Part 2

Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy. (NCT02659059)
Timeframe: Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose

InterventionParticipants (Count of Participants)
Adverse Events (AEs)Serious Adverse Events (SAEs)Deaths due to Disease progressionDeaths due to Study drug toxicityDeaths due to unknown causesDeaths due to other causes
Nivolumab+Ipilimumab+Chemotherapy36269016

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Progression Free Survival (PFS) - Part 2

Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT02659059)
Timeframe: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 59 months)

InterventionMonths (Median)
Nivolumab+Ipilimumab+Chemotherapy10.81

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Response Rate

"Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation.~To test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology (biphasic versus sarcomatoid)." (NCT02709512)
Timeframe: approximately 18 months

InterventionParticipants (Count of Participants)
Drug: ADI-PEG 20 Plus Pem Platinum12
Drug: Placebo Plus Pem Platinum12

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Progression Free Survival

The key secondary endpoint for the phase 3 portion is PFS, which will be analyzed only if the analysis of OS is statistically significant at the final analysis, with alpha level of 0.05 (two-sided) using the same statistical methodologies as applied to OS. (NCT02709512)
Timeframe: approximately 18 months

Interventionmonths (Median)
Drug: ADI-PEG 20 Plus Pem Platinum6.24
Drug: Placebo Plus Pem Platinum5.65

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Overall Survival

"Overall survival is defined as the time from randomization until death. In the event that no death was documented prior to study termination or analysis cutoff, OS was censored at the last known date the subject was known to be alive, either through completion of on-study visits or through survival follow-up contact.~The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology).~The Kaplan-Meier curves were also plotted. A Cox proportional hazard model with an adjustment for tumor histology (biphasic vs sarcomatoid) was used to compute the estimated hazard ratio and two-sided 95% CI. The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology). The significance level to be used in the OS analysis at the final analysis was based on α = 0.04999 (two-sided)." (NCT02709512)
Timeframe: 18 months

Interventionmonths (Median)
Drug: ADI-PEG 20 Plus Pem Platinum9.30
Drug: Placebo Plus Pem Platinum7.66

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Overall Survival Phase 3 Interim Analysis

"The primary analysis of OS Phase 3 was performed at the interim analysis. This was performed once 50% of the planned OS events for phase 3 have occurred (ie, 169 of the 338 planned OS events). This interim analysis will evaluate OS in the ITT population in an unblinded manner. The OS data at the second interim analysis will be analyzed to support the following decisions:~Futility stopping: Terminate the study due to futility at the interim analysis. Sample size re-estimation: Increase the target number of OS events after the second interim analysis.. The treatment effect on OS will be evaluated using the stratified log-rank test (stratified by tumor histology)." (NCT02709512)
Timeframe: Approximately 18 months

Interventionmonths (Median)
Drug: ADI-PEG 20 Plus Pem Platinum9.82
Drug: Placebo Plus Pem Platinum7.49

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Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 - Extended Collection

Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) (NCT02741570)
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)

InterventionMonths (Median)
Nivolumab + Ipilimumab17.74
EXTREME Regimen14.59

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Objective Response Rate (ORR)

"Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT02741570)
Timeframe: From randomization up to approximately 65 months

,
InterventionPercent (Number)
All randomized participantsRandomized PD-L1 CPS >= 20 participants
EXTREME Regimen37.135.4
Nivolumab + Ipilimumab24.234.1

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Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1

Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) (NCT02741570)
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)

InterventionMonths (Median)
Nivolumab + Ipilimumab15.67
EXTREME Regimen13.24

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Duration of Objective Response (DOR)

"The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates)~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT02741570)
Timeframe: From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)

,
InterventionMonths (Median)
All randomized participantsRandomized PD-L1 CPS >= 20 participants
EXTREME Regimen5.886.97
Nivolumab + Ipilimumab16.5933.51

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Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20

Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) (NCT02741570)
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)

InterventionMonths (Median)
Nivolumab + Ipilimumab17.58
EXTREME Regimen14.59

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Progression Free Survival (PFS)

"PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates)~Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)." (NCT02741570)
Timeframe: From randomization to disease progression or death (Up to approximately 65 months)

,
InterventionMonths (Median)
Randomized participantsRandomized PD-L1 CPS >= 20 participants
EXTREME Regimen6.776.97
Nivolumab + Ipilimumab3.295.39

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Overall Survival (OS) in All Randomized Participants - Extended Collection

Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) (NCT02741570)
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)

InterventionMonths (Median)
Nivolumab + Ipilimumab13.90
EXTREME Regimen13.50

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Overall Survival (OS) in All Randomized Participants

Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) (NCT02741570)
Timeframe: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)

InterventionMonths (Median)
Nivolumab + Ipilimumab13.90
EXTREME Regimen13.50

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Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)

EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed. (NCT02855944)
Timeframe: Baseline to the end of Cycle 6, or up to approximately 6 months

Interventionscore on a scale (Least Squares Mean)
Rucaparib0.6
Chemotherapy0.4

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Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)

EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed. (NCT02855944)
Timeframe: Baseline to the end of Cycle 6, or up to approximately 6 months

Interventionscore on a scale (Least Squares Mean)
Rucaparib0.5
Chemotherapy0.3

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Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)

The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib7.4
Chemotherapy5.7

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Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)

The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from Cycle 1 Day 1 (C1D1) until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib7.4
Chemotherapy5.7

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (ITT Population)

A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or response per Gynecologic Cancer InterGroup Cancer Antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of patients (Number)
Rucaparib47.8
Chemotherapy40.5

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population)

A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of participants (Number)
Rucaparib37.9
Chemotherapy30.2

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)

A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of participants (Number)
Rucaparib40.3
Chemotherapy32.3

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Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)

A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionmonths (Median)
Rucaparib9.4
Chemotherapy7.2

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Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)

A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionmonths (Median)
Rucaparib9.4
Chemotherapy7.2

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Overall Survival (ITT Population)

Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive. (NCT02855944)
Timeframe: All patients were followed for survival up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib19.4
Chemotherapy25.4

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Overall Survival (Efficacy Population)

Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive. (NCT02855944)
Timeframe: All patients were followed for survival up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib21.1
Chemotherapy26.2

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (Efficacy Population)

A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or response per Gynecologic Cancer InterGroup Cancer Antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of patients (Number)
Rucaparib50.7
Chemotherapy43.6

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Maximum Concentration (Cmax) of Pembrolizumab in Part A Cycle 1

Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusion

Interventionµg/mL (Geometric Mean)
Part A Combined Cohort 180.0
Part A Combined Cohort 273.8
Part A Combined Cohorts 1 and 276.2

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Number of Participants Who Discontinued Study Treatment Due to An Adverse Event (AE)

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who discontinued due to an AE was reported for each arm. (NCT02862457)
Timeframe: Up to approximately 38.5 months

InterventionParticipants (Count of Participants)
Part A Cohort 1: Epacadostat 25 mg0
Part A Cohort 1: Epacadostat 100 mg1
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab0
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab1
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed0
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed3
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel3

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Trough Concentration (Ctrough) of Epacadostat in Part A

Ctrough was the lowest concentration of epacadostat in plasma just before the next dose for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Ctrough for Cohort 1 was measured on Days 1, 5, and 12 and Ctrough for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Ctrough is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose

,
InterventionnM (Geometric Mean)
Day 5
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab106.0
Part A Cohort 2: Epacadostat 25 mg+PembrolizumabNA

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Time to Maximum Concentration (Tmax) of Epacadostat in Part A

Tmax was the time required to reach the maximum concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Tmax for Cohort 1 was measured on Days 1, 5, and 12 and Tmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Tmax is presented as a Median with a full range. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
Interventionhours (Median)
Day 1Day 5Day 12
Part A Cohort 1: Epacadostat 100 mg2.002.002.00
Part A Cohort 1: Epacadostat 25 mg2.002.002.00

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Time to Maximum Concentration (Tmax) of Epacadostat in Part A

Tmax was the time required to reach the maximum concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Tmax for Cohort 1 was measured on Days 1, 5, and 12 and Tmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Tmax is presented as a Median with a full range. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
Interventionhours (Median)
Day 5
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab2.00
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab2.00

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Terminal Half-Life (t1/2) of Epacadostat in Part A

t1/2 was the time required to divide the epacadostat concentration by two after reaching pseudo-equilibrium. Plasma t1/2 was measured for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, t1/2 for Cohort 1 was measured on Days 1, 5, and 12 and t1/2 for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). t1/2 is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
Interventionhours (Geometric Mean)
Day 1Day 5Day 12
Part A Cohort 1: Epacadostat 100 mg2.552.822.43
Part A Cohort 1: Epacadostat 25 mg3.943.014.27

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Terminal Half-Life (t1/2) of Epacadostat in Part A

t1/2 was the time required to divide the epacadostat concentration by two after reaching pseudo-equilibrium. Plasma t1/2 was measured for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, t1/2 for Cohort 1 was measured on Days 1, 5, and 12 and t1/2 for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). t1/2 is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
Interventionhours (Geometric Mean)
Day 5
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab3.77
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab2.62

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Maximum Concentration (Cmax) of Epacadostat in Part A

Cmax was the maximum observed concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Cmax for Cohort 1 was measured on Days 1, 5, and 12 and Cmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Cmax is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
InterventionnM (Geometric Mean)
Day 1Day 5Day 12
Part A Cohort 1: Epacadostat 100 mg106011001200
Part A Cohort 1: Epacadostat 25 mg327269294

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Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)

A DLT was defined as the occurrence of any treatment-emergent adverse event occurring up to and including Study Day 7 for Part A Cohort 1 or Day 21 for Part A Cohort 2 and Part B. The following criteria defined DLTs: Grade (G) 4 thrombocytopenia; G4 neutropenia (despite optimal supportive care in Part B) lasting >1 week; febrile neutropenia (only if considered clinically significant in Part B); G4 toxicity; G3 laboratory abnormality lasting >1 week: G3 toxicity excluding nausea or vomiting controlled within 72 hours, rash in the absence of desquamation, no mucosal involvement, does not require systemic steroids, and resolves to G1 by the next scheduled dose of pembrolizumab or 14 days; G2 or higher episcleritis, uveitis, or iritis; unable to receive 75% of epacadostat or 1 dose of pembrolizumab during the DLT observation period because of toxicity, even if the toxicity does not meet DLT criteria; or >2 week delay in initiating Cycle 2 due to toxicity. (NCT02862457)
Timeframe: Up to Day 7 for Part A Cohort 1; up to Day 21 for Part A Cohort 2 and Part B

InterventionParticipants (Count of Participants)
Part A Cohort 1: Epacadostat 25 mg0
Part A Cohort 1: Epacadostat 100 mg0
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab0
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab1
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed1
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed2
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel2

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Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A

AUC0-t was defined as the AUC from zero to the time of the last measurable concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, AUC0-t for Cohort 1 was measured on Days 1, 5, and 12 and AUC0-t for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). AUC0-t is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
InterventionnM•hour (Geometric Mean)
Day 1Day 5Day 12
Part A Cohort 1: Epacadostat 100 mg425046704710
Part A Cohort 1: Epacadostat 25 mg85510601020

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Maximum Concentration (Cmax) of Pembrolizumab in Part B Cycle 1

Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+ 3 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusion

Interventionµg/mL (Geometric Mean)
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed73.8
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed64.3
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel65.3
Part B Combined Cohorts 1, 2, and 368.0

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Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A

AUC0-t was defined as the AUC from zero to the time of the last measurable concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, AUC0-t for Cohort 1 was measured on Days 1, 5, and 12 and AUC0-t for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). AUC0-t is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
InterventionnM•hour (Geometric Mean)
Day 5
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab3950
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab1260

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Number of Participants Who Experienced At Least One Adverse Event (AE)

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experienced an AE was reported for each arm. (NCT02862457)
Timeframe: Up to approximately 39.7 months

InterventionParticipants (Count of Participants)
Part A Cohort 1: Epacadostat 25 mg3
Part A Cohort 1: Epacadostat 100 mg2
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab3
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab6
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed7
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed6
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel6

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Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8

Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+3 combined. Per protocol, blood sampling for Ctrough was taken at pre-dose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Predose prior to the Cycles 1, 2, 4, 6, and 8 infusion

,,,
Interventionµg/mL (Geometric Mean)
Cycle 1Cycle 2Cycle 4Cycle 6Cycle 8
Part B Cohort 1: Pembrolizumab+Cisplatin+PemetrexedNA16.637.853.865.4
Part B Cohort 2: Pembrolizumab+Carboplatin+PemetrexedNA17.428.140.552.7
Part B Cohort 3: Pembrolizumab+Carboplatin+PaclitaxelNA8.6925.421.534.5
Part B Combined Cohorts 1, 2, and 3NA13.331.538.650.3

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Trough Concentration (Ctrough) of Epacadostat in Part A

Ctrough was the lowest concentration of epacadostat in plasma just before the next dose for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Ctrough for Cohort 1 was measured on Days 1, 5, and 12 and Ctrough for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Ctrough is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose

,
InterventionnM (Geometric Mean)
Day 1Day 5Day 12
Part A Cohort 1: Epacadostat 100 mgNA87.795.4
Part A Cohort 1: Epacadostat 25 mgNANANA

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Maximum Concentration (Cmax) of Epacadostat in Part A

Cmax was the maximum observed concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Cmax for Cohort 1 was measured on Days 1, 5, and 12 and Cmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Cmax is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose

,
InterventionnM (Geometric Mean)
Day 5
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab852
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab371

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Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8

Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, blood sampling for Ctrough was taken at predose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation. (NCT02862457)
Timeframe: Predose prior to the Cycles 1, 2, 4, 6, and 8 infusion

,,
Interventionµg/mL (Geometric Mean)
Cycle 1Cycle 2Cycle 4Cycle 6Cycle 8
Part A Combined Cohort 1NA17.324.528.538.2
Part A Combined Cohort 2NA17.941.851.047.9
Part A Combined Cohorts 1 And 2NA17.635.039.845.2

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Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionh*ug/ml (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)4800
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)12300
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)39800
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)10800

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Number of All Study Participants Who Demonstrate a Tumor Response

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionParticipants (Number)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)0
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)1
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)0
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)1
MEL: Sintilimab 200mg Q3W (Cohort A)1
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)13
NSCLC: Sintilimab 200mg Q3W (Cohort C)5
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)13
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)11
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)17
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)3
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)1

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DOR According to RECIST 1.1 as Assessed by Investigator

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)NA
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)NA
NSCLC: Sintilimab 200mg Q3W (Cohort C)368.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)NA
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)170.5
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)181.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)NA

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Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

(NCT02937116)
Timeframe: Up to 28 days in Cycle 1

InterventionParticipants (Number)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)0
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)0
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)0
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)0

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Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator

ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1. (NCT02937116)
Timeframe: Through out the study (up to 2 years)

Interventionpercentage of participants (Number)
MEL: Sintilimab 200mg Q3W (Cohort A)4.5
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)14.9
NSCLC: Sintilimab 200mg Q3W (Cohort C)13.5
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)61.9
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)55.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)85.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)42.9
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)14.3

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OS for Participants

(NCT02937116)
Timeframe: Through out the study

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)518.0
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)342.0
NSCLC: Sintilimab 200mg Q3W (Cohort C)431.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)566.0
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)461.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)NA

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PFS According to RECIST 1.1 as Assessed by Investigator

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)62.0
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)66.0
NSCLC: Sintilimab 200mg Q3W (Cohort C)84.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)377.0
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)194.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)230.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)NA

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Clearance of IBI308 in Plasma After Single Dose Administration

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionml/h (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)8.53
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)11.7
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)13.7
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)12.9

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The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

InterventionDays (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)17
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)12.7
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)12.5
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)16.1

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Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionug/ml (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)21.9
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)69.7
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)220
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)54.6

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Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionhours (Median)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)1.05
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)2.07
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)2.27
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)1.93

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TTR According to RECIST 1.1 as Assessed by Investigator

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)63.0
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)64.0
NSCLC: Sintilimab 200mg Q3W (Cohort C)63.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)63.0
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)62.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)63.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)62.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)62.0

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Volume of Distribution of IBI308 in Plasma After Single Dose Administration

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

InterventionL (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)5.02
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)5.14
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)5.95
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)7.2

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Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window

Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population. (NCT02983045)
Timeframe: Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.

,,
InterventionParticipants (Count of Participants)
Patients with at least one eventEndocrine disorders: Adrenal insufficiencyEndocrine disorders: HyperthyroidismMetabolism and nutrition disorders: Hyponatraemia
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab1001
Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab1100
Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab1010

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Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window

Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population. (NCT02983045)
Timeframe: Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.

,,,,
InterventionParticipants (Count of Participants)
At least 1 DLTMetabolism and Nutrition Disorders: AcidosisMetabolism and Nutrition Disorders: HyperglycaemiaVascular Disorders: Hypotension
Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w0000
Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w0000
Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w0000
Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w0000
Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w2111

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Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production

Xerostomia will also be assessed by measurement of unstimulated saliva production post treatment. (NCT02990468)
Timeframe: 6 months

Interventiongram (Mean)
Phase 1: Group 10.42
Phase 1: Group II1.090
Phase 2: Group III1.255

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Incidence of Radiation-induced Xerostomia by Clinician Scoring

Xerostomia will be assessed using Maximum Xerostomia Clinical Score Common Terminology Criteria for Adverse Events (CTCAE) 4.03. Scores range from 0 to 5 with 0 being no xerostomia and 5 being the worst. Mean maximum xerostomia grade of patients assessed is reported. (NCT02990468)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Phase 1: Group 11
Phase 1: Group II1.33
Phase 2: Group III1.29

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Duration of Radiation-induced Mucositis

Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Duration of Oral Mucositis WHO Grade 3 or higher measured as the days of severe oral mucositis. (NCT02990468)
Timeframe: 6 month 6 months

Interventiondays (Mean)
Phase 1: Group 122
Phase 1: Group II18
Phase 2: Group III37.4

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Incidence of Radiation-induced Xerostomia by Stimulated Saliva Production

Xerostomia will also be assessed by measurement of stimulated saliva production posttreatment. (NCT02990468)
Timeframe: 6 months

Interventiongram (Mean)
Phase 1: Group 11.487
Phase 1: Group II2.387
Phase 2: Group III2.115

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Incidence Radiation-induced Mucositis by Clinician Scoring

Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Higher scores are indicative of worse symptoms. Grade 0-5. We are reporting the incidence of the patients that had mucositis grade 1-5. (NCT02990468)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Phase 1: Group 11
Phase 1: Group II1
Phase 2: Group III10

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PFS2 in PD-L1 TC >= 25% LREM Analysis Set

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.8
Platinum-based SoC10.9

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PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% LREM Analysis Set

The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab5.7
Platinum-based SoC5.5

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PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% Analysis Set

The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab5.6
Platinum-based SoC4.5

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PFS Based on Investigator Assessment According to RECIST 1.1 in LREM Analysis Set

The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab5.5
Platinum-based SoC5.6

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Overall Survival (OS)

OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months [data cut-off (DCO) 27 October 2022]

Interventionmonths (Median)
Durvalumab14.6
Platinum-based SoC12.8

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OS in PD-L1 TC >= 50% LREM Analysis Set

OS is defined as the time from the date of randomization until death due to ay cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab14.9
Platinum-based SoC14.9

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OS in PD-L1 TC >= 50% Analysis Set

OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab14.6
Platinum-based SoC11.8

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OS in Participants With LREM

OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab14.6
Platinum-based SoC15.0

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OS at 24 Months in PD-L1 TC >= 50% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab36.9
Platinum-based SoC32.6

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OS at 24 Months in PD-L1 TC >= 50% Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab37.0
Platinum-based SoC27.0

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OS at 24 Months in PD-L1 TC > = 25% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab34.7
Platinum-based SoC32.8

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OS at 24 Months

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab34.6
Platinum-based SoC27.2

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OS at 18 Months in PD-L1 TC >= 50% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months

Interventionpercentage of participants (Number)
Durvalumab44.3
Platinum-based SoC42.2

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OS at 18 Months in PD-L1 TC >= 50% Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months

Interventionpercentage of participants (Number)
Durvalumab43.2
Platinum-based SoC34.9

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OS at 18 Months in PD-L1 TC > = 25% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months

Interventionpercentage of participants (Number)
Durvalumab43.0
Platinum-based SoC41.4

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OS at 18 Months

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months.

Interventionpercentage of participants (Number)
Durvalumab42.5
Platinum-based SoC34.2

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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% LREM Analysis Set

ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab44.0
Platinum-based SoC43.7

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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% Analysis Set

ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab42.1
Platinum-based SoC40.7

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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 25% LREM Analysis Set

ORR (per RECIST 1.1 using Investigator assessments)was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab38.5
Platinum-based SoC40.2

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Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment

ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs). Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab37.6
Platinum-based SoC37.4

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Duration of Response (DoR) as Per RECIST 1.1 Using Investigator Assessment

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.9
Platinum-based SoC4.2

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DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% LREM Analysis Set

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab12.2
Platinum-based SoC4.2

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DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% Analysis Set

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab12.2
Platinum-based SoC4.2

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DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=25% LREM Analysis Set

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.6
Platinum-based SoC4.2

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APF12 in PD-L1 TC >= 50% LREM Analysis Set

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab26.5
Platinum-based SoC14.5

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APF12 in PD-L1 TC >= 50% Analysis Set

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab26.1
Platinum-based SoC11.7

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APF12 in PD-L1 TC >= 25% LREM Analysis Set

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab24.1
Platinum-based SoC16.4

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Alive and Progression-Free at 12 Months (APF12)

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab25.5
Platinum-based SoC13.3

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Time to Deterioration of EORTC QLQ-LC13

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
CoughDyspneaChest pain
Durvalumab7.52.89.0
Platinum-based SoC6.63.66.4

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Time to Deterioration of EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
CoughDyspneaChest pain
Durvalumab9.23.69.8
Platinum-based SoC8.23.66.6

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Time to Deterioration of EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
Global health statusPhysical functioningAppetite lossFatigue
Durvalumab7.47.49.35.5
Platinum-based SoC5.54.73.71.8

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Time to Deterioration of EORTC QLQ-C30

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration (a decrease in the function scales or the global health status/ health-related quality of life [HRQoL] from baseline of ≥10) that was confirmed at a subsequent visit or death in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
Global health statusPhysical functioningAppetite lossFatigue
Durvalumab7.37.49.24.9
Platinum-based SoC3.83.83.61.8

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Percentage of Participants With Antidrug Antibody (ADA) Response to Durvalumab

Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. (NCT03003962)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Treatment-emergent ADA positiveTreatment-boosted ADAPersistently positiveTransiently positive
Durvalumab0.80.400.8

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Percentage of Participants With ADA Response to Durvalumab in LREM Analysis Set

Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. (NCT03003962)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Treatment-emergent ADA positiveTreatment-boosted ADAPersistently positiveTransiently positive
Durvalumab1.00.501.0

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Number of Participants With ECOG Performance Status in PD-L1 TC >=25% LREM Analysis Set

ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported. (NCT03003962)
Timeframe: From Baseline and until follow-up period of 57 months

,
Interventionnumber of participants (Number)
Restricted activity, BaselineRestricted activity, Follow-up Month 57
Durvalumab2210
Platinum-based SoC2032

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Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported. (NCT03003962)
Timeframe: From Baseline and until follow-up period of 57 months

,
Interventionnumber of participants (Number)
Restricted activity, BaselineRestricted activity, Follow-up Month 57
Durvalumab2670
Platinum-based SoC2552

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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire Version 3 (QLQ-C30)

The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
Global health statusPhysical functioningFatigueAppetite loss
Durvalumab-0.7-3.31.4-1.1
Platinum-based SoC-7.4-6.17.29.1

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Change From Baseline in EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set

The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
CoughDyspneaChest pain
Durvalumab-6.62.9-0.7
Platinum-based SoC-8.63.9-1.0

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Change From Baseline in EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set

The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
Global health statusPhysical functioningFatigueAppetite loss
Durvalumab-1.4-3.92.2-0.2
Platinum-based SoC-7.3-6.07.79.8

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Change From Baseline in EORTC 13-Item Lung Cancer Quality of Life Questionnaire (QLQ-LC13)

The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
CoughDyspneaChest pain
Durvalumab-6.42.4-1.0
Platinum-based SoC-7.94.1-0.2

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Time From Randomization to Second Progression (PFS2)

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.3
Platinum-based SoC9.3

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Progression Free Survival (PFS) Based on Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

The PFS (per RECIST 1.1) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). Progression of disease per RECIST 1.1, when either 1 of the criteria met: Target lesion (TL): at least a 20% increase in the sum of diameters of TLs, for reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Non-target lesion (NTL): Unequivocal progression of existing NTLs. It may be due to an important progression in 1 lesion only or in several lesions. In all cases the progression must be clinically significant for the physician to consider changing (or stopping) therapy. New lesions: the presence of 1 or more new lesions was assessed as progression. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab5.4
Platinum-based SoC4.8

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PFS2 in PD-L1 TC >= 50% LREM Analysis Set

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab12.0
Platinum-based SoC10.9

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PFS2 in PD-L1 TC >= 50% Analysis Set

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.3
Platinum-based SoC8.8

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Change From Baseline in Global Health Status/Quality of Life (GHS/QoL)

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) contains 30 items and measures five functional dimensions (physical, role, emotional, cognitive and social), three symptom items (fatigue, nausea/vomiting, and pain), six single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, so that a higher score indicates a better overall GHS. A change from baseline of 10 points on the 100-point EORTC QLQ-C30 scale is considered as clinically relevant. Based on a constrained longitudinal data analysis (cLDA) model with the patient reported outcomes (PRO) scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of human papilloma virus (HPV) status and overall cancer stage. (NCT03040999)
Timeframe: Prior to the first dose of study treatment (Baseline) and up to Week 45

InterventionScore on a scale (Least Squares Mean)
Pembrolizumab + Cisplatin + CRT1.95
Placebo + Cisplatin + CRT6.08

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Change From Baseline in Physical Functioning

Participant responded to 5 questions from the EORTC QLQ-C30 about their physical functioning scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100, where a higher score indicates a better quality of life. A change from baseline of 10 points on the 100-point scale is considered as clinically relevant. Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage. (NCT03040999)
Timeframe: Prior to the first dose of study treatment (Baseline) and up to Week 45

InterventionScore on a scale (Least Squares Mean)
Pembrolizumab + Cisplatin + CRT-5.54
Placebo + Cisplatin + CRT-3.46

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Event-free Survival (EFS)

EFS is the time from date of randomization to the date of first record of any of the following events: death due to any cause; progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR) or biopsy as indicated for locoregional progression or recurrence or distant metastasis. As well as the first record of the following types of surgery: salvage surgery for persistent or residual disease at the primary tumor site requiring surgical removal when invasive cancer is present on final pathology; neck dissection or surgery (performed for clinical or radiological disease progression per RECIST 1.1) ≤ 20 weeks from end of CRT when invasive cancer is present; or neck dissection or surgery >20 weeks from end of CRT when invasive cancer is present. From product-limit (Kaplan-Meier) method for censored data. (NCT03040999)
Timeframe: Up to approximately 62 months

InterventionMonths (Median)
Pembrolizumab + Cisplatin + CRTNA
Placebo + Cisplatin + CRT46.6

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Number of Participants Discontinuing Study Drug Due to an AE

An AE is any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE is any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. (NCT03040999)
Timeframe: From time of first dose of study treatment until the end of treatment (up to approximately 16 months)

InterventionParticipants (Count of Participants)
Pembrolizumab + Cisplatin + CRT164
Placebo + Cisplatin + CRT132

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Change From Baseline in Swallowing, Speech, and Pain Symptoms

EORTC QLQ Head and Neck Questionnaire (H&N35) consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality), Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Change from baseline in swallowing, speech, and pain symptoms was measured. A change from baseline of 10 points on the 100-point EORTC QLQ-H&N35 is considered as clinically relevant. Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage. (NCT03040999)
Timeframe: Prior to the first dose of study treatment (Baseline) and up to Week 45

,
InterventionScore on a scale (Least Squares Mean)
SwallowingSpeechPain
Pembrolizumab + Cisplatin + CRT-3.88-6.23-10.62
Placebo + Cisplatin + CRT-3.56-4.97-12.07

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Overall Survival (OS)

OS is the time from randomization to death due to any cause, from product-limit (Kaplan-Meier) method for censored data. The hypothesis was that pembrolizumab in combination with CRT is superior to placebo in combination with CRT; but based on the protocol, because the statistical criterion for success in the primary EFS hypothesis was not met, the OS hypothesis was not tested (NCT03040999)
Timeframe: Up to approximately 62 months

InterventionMonths (Median)
Pembrolizumab + Cisplatin + CRTNA
Placebo + Cisplatin + CRTNA

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Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE is any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. (NCT03040999)
Timeframe: From time of first dose of study treatment until 90 days after last dose (up to approximately 19 months)

InterventionParticipants (Count of Participants)
Pembrolizumab + Cisplatin + CRT398
Placebo + Cisplatin + CRT397

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Number of Patients With Solitary Elective Volume Recurrence

The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator. (NCT03067610)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Radiation Therapy0

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Overall Survival

Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method. (NCT03067610)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Radiation Therapy89

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Progression-free Survival

Progression-free survival will be calculated from the initiation of treatment. Progression is confirmed by biopsy, which will be used as the date of progression. (NCT03067610)
Timeframe: 2 year

Interventionpercentage of patients (Number)
Radiation Therapy79

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Total Number of Participants With Gastrostomy Dependence

The prevalence of gastrostomy use up to 2 years will be described. (NCT03067610)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Radiation Therapy31

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Probability of Locoregional or Distant Tumor Failure

The percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk. Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death. (NCT03067610)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Locoregional recurrenceDistant metastasis
Radiation Therapy1414

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Quality of Life (QOL) Patient Reported Outcomes (PRO)

"Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI).~EORTC QLQ-C30 and QLQ-H&N35 are scored on a 4-point categorical scale ranging from 1 not at all to 4 very much. This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms.~MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning." (NCT03067610)
Timeframe: 12 months

,,,
Interventionscore on a scale (Mean)
EORTC QLQ30 globalEORTC QLQ30 physical fcnEORTC QLQ30 role fcnEORTC QLQ30 emotional fcnEORTC QLQ30 cognitive fcnEORTC QLQ30 social fcnEORTC HN35 dry mouthEORTC HN35 sticky salivaEORTC HN35 sensesEORTC HN35 painEORTC HN35 speechComposite MDADI
Total Cohort 12 Month85.993.095.388.290.790.338.027.115.97.99.884.9
Total Cohort 3 Month76.987.482.587.789.585.159.038.025.716.513.479.6
Total Cohort 6 Month79.290.385.682.986.485.647.727.320.114.219.276.9
Total Cohort Baseline71.490.381.978.090.085.214.415.76.724.418.481.3

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Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab

Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against durvalumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. (NCT03164616)
Timeframe: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, durvalumab).

,
InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (ADA positive post-baseline only)ADA positive at baseline onlyADA positive post-baseline and positive at baselinePersistently positiveTransiently positivenAb positive at any visit
D + SoC33191181327133
T + D + SoC4229227878263

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PK of Tremelimumab; Peak and Trough Serum Concentrations

To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively. (NCT03164616)
Timeframe: Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021.

Interventionμg/mL (Geometric Mean)
Week 0Week 3Week 12Follow-up (3 months)
T + D + SoC23.174.167.820.86

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Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13)

The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and treatment-related symptoms from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration. (NCT03164616)
Timeframe: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever came first). Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

,,
Interventionmonths (Median)
QLQ-LC13 CoughQLQ-LC13 HemoptysisQLQ-LC13 DyspneaQLQ-LC13 Pain in ChestQLQ-LC13 Pain in Arm or ShoulderQLQ-LC13 Pain in Other Parts
D + SoC11.014.05.09.58.98.9
SoC Alone8.811.43.68.68.85.8
T + D + SoC9.717.85.410.08.99.7

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Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations

To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively. (NCT03164616)
Timeframe: Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021.

,
Interventionmicrograms/milliliter (μg/mL) (Geometric Mean)
Week 0Week 3Week 12Follow-up (3 months)
D + SoC505.0191.53212.1116.06
T + D + SoC418.8082.08195.6213.42

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Duration of Response (DoR)

DoR (per RECIST 1.1 using BICR assessments) was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. The end of response coincided with the date of progression or death from any cause used for the RECIST 1.1 PFS endpoint. The time of the initial response was defined as the latest of the dates contributing towards the first visit of PR or CR. Results are presented for the pre-specified DoR analysis using unconfirmed responses based on BICR. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionmonths (Median)
T + D + SoC7.4
D + SoC6.0
SoC Alone4.2

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Number of Patients With ADA Response to Tremelimumab

Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against tremelimumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. (NCT03164616)
Timeframe: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, tremelimumab).

InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (ADA positive post-baseline only)ADA positive at baseline onlyADA positive post-baseline and positive at baselinePersistently positiveTransiently positivenAb positive at any visit
T + D + SoC443833545221831

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Time From Randomization to Second Progression (PFS2)

PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS) or death. The date of second progression was recorded by the Investigator and defined according to local standard clinical practice and could involve any of: objective radiological imaging, symptomatic progression or death. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionmonths (Median)
T + D + SoC10.4
D + SoC10.2
SoC Alone9.4

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Progression-Free Survival (PFS); D + SoC Compared With SoC Alone

PFS (per RECIST version 1.1 [RECIST 1.1] using Blinded Independent Central Review [BICR] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity). (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionmonths (Median)
D + SoC5.5
SoC Alone4.8

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PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

PFS (per RECIST 1.1 using BICR assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months.

Interventionmonths (Median)
T + D + SoC6.2
D + SoC5.5
SoC Alone4.8

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Overall Survival (OS); D + SoC Compared With SoC Alone

OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity). (NCT03164616)
Timeframe: From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

Interventionmonths (Median)
D + SoC13.3
SoC Alone11.7

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OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT03164616)
Timeframe: From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

Interventionmonths (Median)
T + D + SoC14.0
D + SoC13.3
SoC Alone11.7

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Objective Response Rate (ORR)

ORR (per RECIST 1.1 using BICR assessments) was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR). Results are presented for the pre-specified ORR analysis using unconfirmed responses based on BICR. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionpercentage of patients (Number)
T + D + SoC46.3
D + SoC48.5
SoC Alone33.4

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Overall Survival (OS)

OS was defined as the time from the first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. The median duration of OS was not derived for less than (<) 10 participants. (NCT03317496)
Timeframe: From first dose of study treatment until death due to any cause (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin18.1
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin15.1

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Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT)

DLTs=occurrence of any AEs attributable to study treatment in first 2 treatment cycles:Hematologic: grade(G)4 neutropenia lasting >7days;febrile neutropenia with body temperature >=38 degree Celsius for >1hour; G>=3 neutropenic infection(absolute neutrophil count <1.0*10^9/L),G>=3 thrombocytopenia (platelet count<50.0-25.0*10^9/L)with bleeding;G4 thrombocytopenia(PC<25.0*10^9/L),G4 anemia(life-threatening).Non-hematologic: any G4 toxicities;G3 toxicities persisting for >3days despite medical treatment(nausea,vomiting,diarrhea)except endocrinopathies controlled with hormonal therapy;ALT/AST >3*upper limit of normal(ULN)if normal at baseline or 2*Baseline(>ULN at baseline)with total bilirubin >2*ULN and alkaline phosphatase <2*ULN;G3 QTcF prolongation after correction of any reversible cause(electrolyte abnormalities/hypoxia).Delay of >=3weeks in scheduled administration/failure to deliver 75% of doses due to toxicities attributable to any study treatment. DLT-evaluable analysis set. (NCT03317496)
Timeframe: Day 1 up to Week 6 (first 2 treatment cycles; 1 cycle = 21 days)

InterventionParticipants (Count of Participants)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin0
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin1
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin0
Phase 1b Lead-in: Avelumab 1200mg+Gemcitabine/Cisplatin1

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Progression Free Survival (PFS) as Per RECIST v 1.1 by Investigator Assessment

PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. The median duration of PFS was not derived for less than (<) 10 participants. (NCT03317496)
Timeframe: From start of treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin9.8
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin5.4

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Time-to-Tumor Response (TTR) as Per RECIST v 1.1 by Investigator Assessment

TTR was defined as the time from the date of first dose of study treatment to the first documentation of objective response (CR or PR) as assessed by investigator according to RECIST v 1.1. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. (NCT03317496)
Timeframe: From first dose of study treatment until first documentation of CR or PR (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin2.8
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin1.4
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin1.3
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin1.5

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Number of Participants With Grade 3 or Higher Laboratory Abnormalities by CTCAE Grade

Participants with laboratory abnormalities of any Grade as per NCI CTCAE toxicity grading v4.03 were summarized:hematology(anemia,hemoglobin increased,lymphocyte count decreased,lymphocyte count increased, neutrophil count decreased,platelet count decreased and white blood cell decreased)and clinical chemistry(alanine aminotransferase increased,alkaline phosphatase,increased,aspartate,aminotransferase increased,blood bilirubin increased,cholesterol high,creatinine phosphokinase[cpk] increased,creatinine increased,gamma-glutamyl transferase[ggt] increased,hypercalcemia,hyperglycemia,hyperkalemia, hypermagnesemia,hypernatremia,hypertriglyceridemia,hypoalbuminemia,hypocalcemia,hypoglycemia,hypokalemia,hypomagnesemia,hyponatremia, hypophosphatemia,serum amylase increased and lipase increased).As per NCI CTCAE toxicity grading v4.03, Grade1=mild;Grade2=moderate;Grade3=severe;Grade4=life-threatening;Grade 5=death.Parameters with at least 1 participant with abnormal value are reported. (NCT03317496)
Timeframe: From screening up to 90 days after last dose of study drug (maximum up to 5 years approximately)

,,,
InterventionParticipants (Count of Participants)
ALANINE AMINOTRANSFERASE INCREASEDALKALINE PHOSPHATASE INCREASEDASPARTATE AMINOTRANSFERASE INCREASEDBLOOD BILIRUBIN INCREASEDCPK INCREASEDCREATININE INCREASEDGGT INCREASEDHYPERGLYCEMIAHYPERKALEMIAHYPOKALEMIAHYPONATREMIALIPASE INCREASEDSERUM AMYLASE INCREASEDHYPOPHOSPHATEMIAHYPOMAGNESEMIAHYPOCALCEMIAHYPERTRIGLYCERIDEMIAHYPERNATREMIAHYPERMAGNESEMIAHYPERCALCEMIAANEMIALYMPHOCYTE COUNT DECREASEDLYMPHOCYTE COUNT INCREASEDNEUTROPHIL COUNT DECREASEDPLATELET COUNT DECREASEDWHITE BLOOD CELL DECREASED
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin00000010001101000000010303
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin10110122102220003000550827
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin10100102010102020000230332
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin31201044254443212111671211116

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Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression

PD-L1 expression was determined using the Ventana PD-L1 SP263 IHC assay. PD-L1-positive status in UC cohorts was defined using an algorithm that combines assessments of PD-L1 staining on tumor and immune cells scored by pathologists and in NSCLC cohorts was defined as PD-L1 expression on >=1% of tumor cells. PD-L1 expression at baseline and on-treatment were reported in this outcome measure. (NCT03317496)
Timeframe: Baseline and Cycle 2 Day 8 (each cycle of 21 days)

,,,
InterventionParticipants (Count of Participants)
Baseline- Positive PD-L1Baseline- Negative PD-L1Baseline- Unknown PD-L1On-treatment (Cycle 2 Day 8)- Positive PD-L1On-treatment (Cycle 2 Day 8)- Negative PD-L1On-treatment (Cycle 2 Day 8)- Unknown PD-L1
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin141105
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin6702110
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin042024
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin281303632

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Adverse event (AE) was any untoward medical occurrence in a participants who received any study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. (NCT03317496)
Timeframe: From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately)

,,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEs
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin65
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin139
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin63
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin4020

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Serum Concentration of Avelumab

The lower limit of quantification (LLOQ) for avelumab was 0.2 micrograms per milliliter. Pharmacokinetic concentration analysis set was subset of safety analysis set and included participants who had at least one concentration measurement for avelumab or other study drugs which they were assigned to receive. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. (NCT03317496)
Timeframe: Pre-dose, 1 hour post-dose on Day 1 of Cycle 1, 2, 3, 6, 10, 14; 336 hours post-dose on Day 15 of Cycle 1, 2, 3 (each cycle of 21 days)

,,,
InterventionMicrograms per milliliter (Geometric Mean)
Cycle 1/Day 1- 1 hourCycle 1/Day 15- 336 hoursCycle 2/Day 1- pre-doseCycle 2/Day 1- 1 hourCycle 2/Day 15- 336 hoursCycle 3/Day 1- pre-doseCycle 3/Day 1- 1 hourCycle 3/Day 15- 336 hoursCycle 6/Day 1- pre-doseCycle 6/Day 1- 1 hourCycle 10/Day 1- pre-doseCycle 10/Day 1- 1 hourCycle 14/Day 1- pre-doseCycle 14/Day 1- 1 hour
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin284.116.514.328104.516.824.87893.8126.1710.86245.46.6206.04012.2429.05
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin172.29.5703.754197.013.555.651204.017.159.518208.38.695222.013.37216.6
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin173.312.324.780164.216.878.122147.019.4011.3892.539.523179.014.97215.3
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin300.214.715.013311.918.666.771296.822.5510.39344.018.55242.916.49402.2

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Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment

OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. (NCT03317496)
Timeframe: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately)

InterventionPercentage of Participants (Number)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin50.0
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin53.8
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin33.3
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin39.0

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Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue

Mutational load within tumor tissue was defined as number per megabase of the genome, coding, base substitution, and indel mutations present in the sample. Mutational load was determined in whole blood samples using next generation deoxyribonucleic acid (DNA) sequencing followed by computational analysis. (NCT03317496)
Timeframe: Pre-dose on Day 1 of Cycle 1

InterventionMutations per megabase (Mean)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin4.3
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin2.8
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin4.4
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin2.5

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Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment

DOR was defined as time from first documentation of objective response (confirmed CR or PR) to the date of first PD documentation or death due to any cause, whichever occurs first. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. Median DOR was not derived for < 5 participants. (NCT03317496)
Timeframe: From date of first documented response to date of first documented PD or death due to any cause, whichever occurred first (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin9.6
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/CisplatinNA

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Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03

AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using NCI CTCAE v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with grade 3 or higher TEAEs were reported. (NCT03317496)
Timeframe: From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately)

InterventionParticipants (Count of Participants)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin5
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin12
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin6
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin37

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Progression-free Survival

To obtain preliminary information about the progression-free survival of AZD1775 in combination with radiotherapy and concurrent cisplatin in women with locally advanced gynecological cancer. Progression is defined a clinical or radiological using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT03345784)
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years

InterventionParticipants (Count of Participants)
4 Months Post Treatment725043674 Months Post Treatment725043682 Years Post Treatment725043672 Years Post Treatment72504368
Lost to Follow-UpAlive and progression-free post-treatment
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -14
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 10
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -10
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 13
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -13
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -11

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Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin

To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments. (NCT03345784)
Timeframe: Up to 2 years

,
Interventionevents (Number)
All Grade 1-2 ToxicitiesRelated Grade 1-2 ToxicitiesAll Grade 3-4 ToxicitiesRelated Grade 3-4 Toxicities
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1533633
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1463788

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Response Rate

"Best overall response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was defined as complete response (CR) or partial response (PR).~CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." (NCT03382561)
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months

Interventionproportion of participants (Number)
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)0.77
Arm B (Cisplatin/Carboplatin and Etoposide; CE)0.80

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Overall Survival (OS)

OS is defined as the time from maintenance randomization until death of any cause. (NCT03382561)
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until off treatment or end of observation. Then every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months.

Interventionmonths (Median)
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)11.2
Arm B (Cisplatin/Carboplatin and Etoposide; CE)8.1

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Progression-free Survival (PFS)

"PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free.~Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression was defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm." (NCT03382561)
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months

Interventionmonths (Median)
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)5.5
Arm B (Cisplatin/Carboplatin and Etoposide; CE)4.9

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Tumor Response Rate of Newly Diagnosed p16INK4a Negative, HPV-unrelated HNSCC to Neoadjuvant Palbociclib Monotherapy

"Tumor response rate is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) based on RECIST criteria~CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." (NCT03389477)
Timeframe: 2 cycles (56 days)

InterventionParticipants (Count of Participants)
Step 1 Neoadjuvant Palbociclib for Cohort 1 and Cohort 26

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Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities

"The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2.~This measures presents the number of reported dose-limiting toxicities during the PRV111 treatment period" (NCT03502148)
Timeframe: 4 treatment visits in the 21 days prior to surgery

Interventiondose-limiting toxicities (Number)
Neoadjuvant PRV111 (Safety Population)0

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Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses

"The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2.~This measures presents the number of tumor responses during the PRV111 treatment period" (NCT03502148)
Timeframe: Subjects were evaluated for efficacy during the 4 treatment visits in the 21 days prior to surgery

InterventionParticipants (Count of Participants)
Neoadjuvant PRV111 (Efficacy Population)7

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Number of Loco-regional Recurrences

Number of loco-regional recurrences at follow-up (NCT03502148)
Timeframe: Assessed 1, 3 and 6 months post surgery

Interventionnumber of locoregional recurrences (Number)
Neoadjuvant PRV111 (Efficacy Population)0

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Systemic Platinum Levels (Cmax)

Levels of platinum content in blood, using a validated bioanalytical ICP-MS method. Blood drawn was digested via microwave and used to evaluate the amount of systemic cisplatin exposure from PRV111 (Correlated to the amount of platinum detected). A single value for Cmax was calculated by averaging values for all subjects. (NCT03502148)
Timeframe: Cmax is a single value of the highest concentration of platinum in the blood reported from samples taken post-dose across all 4 treatment visits (Baseline [0], 30, 60, and 120 minutes at Visits 1-4)

InterventionµM (Mean)
Neoadjuvant PRV111 (Safety Population)0.24

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Technical Success - Residual Cisplatin Levels Post-application

Platinum content in each residual PRV111, using a validated bioanalytical ICP-MS method and the results for all applications were averaged. (NCT03502148)
Timeframe: 4 treatment visits in the 21 days prior to surgery

Interventionpercentage of drug released (Mean)
Neoadjuvant PRV111 (Safety Population)91.7

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Tumor Response (Tumor Volume Change From Baseline and Pre-op Visit, Approximately 21 Days Prior to Surgical Excision of the Tumor)

Assessed by clinical measurement at baseline and at the pre-op visit (NCT03502148)
Timeframe: Assessed within the 21 days prior to surgical excision of the tumor

Interventionpercentage of tumor volume reduction (Mean)
Neoadjuvant PRV111 (Efficacy Population)69

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Tumor and Lymph Node (if Available) Platinum Levels

Levels of platinum content in tumor tissue and/or lymph tissue, using a validated bioanalytical ICP-MS method. Resected tissues were digested via microwave and used to evaluate the amount of cisplatin delivered by PRV111 (Correlated to the amount of platinum detected). (NCT03502148)
Timeframe: 21 days from baseline through surgical excision of the tumor

Interventionµg/g (Mean)
Average Tumor Platinum LevelAverage Lymph Node Platinum Level
Neoadjuvant PRV111 (Safety Population)337110

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Imaging-based Tumor Response: Complete Tumor Clearance Determined by Physician Performing Imaging

Clearance (yes or no) will be evaluated using non-invasive dynamic optical coherence tomography, high-intensity focused ultrasound and reflectance confocal microscopy imaging at Day 30 and Month 3. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines. (NCT03541252)
Timeframe: Day 30 and 3 months post treatment

InterventionParticipants (Count of Participants)
Day 30Month 3
Basal Cell Carcinoma Patients1318

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Tumor Response- Clinical Clearance Determined by Clinical Assessment by Physician

Tumor clearance (yes or no) will be evaluated clinically at Day 30 and Month 3. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines.¨ (NCT03541252)
Timeframe: Day 30 and Month 3 post treatment

InterventionParticipants (Count of Participants)
Clinical Clearance Day 30Clinical Clearance Month 3
Basal Cell Carcinoma Patients1318

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Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE

Non-blinded, clinical evaluation of local erythema, edema, flaking, crusting/scabbing, pustulation, scarring, hypo/hyperpigmentation, infection in treated areas will be performed by a physician using a FDA-approved LSR scale at Days 1, 3-5, 14, 30 and 3 months after AFL exposure. Each parameter was graded on a standardized 5-point severity scale (0-4) representing none, mild, moderate, prominent, and severe. A total composite score reflecting overall LSR severity was then calculated based on the sum of all parameters (minimum score 0- least severe; max score: 24-most severe). lower scores are better. (NCT03541252)
Timeframe: Days 1, 3-5, 14, 30 and 3 months post treatment

Interventionscore on a scale (Median)
Day 1 post treatmentDay 3-5 post treatmentDay 30 post treatmentMonth 3 post treatment
Basal Cell Carcinoma Patients7942

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Tumor Response- Histological Tumor Clearance Determined by Pathologist

"Histological verification of tumor clearance will be performed 3 months after first treatment using tissue sections from a 4 mm punch biopsy. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines.~NOTE: Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module since only 18 of the 19 patients consented to undergoing histologicla verification with biopsy. Those, presented data represents patients that underwent biopsy at the 3 month mark." (NCT03541252)
Timeframe: 3 months post treatment

InterventionParticipants (Count of Participants)
Basal Cell Carcinoma Patients17

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Progression-free Survival

Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier. (NCT03617913)
Timeframe: From registration to time of first documentation of progression or death from any cause, assessed up to 12 months

Interventionyears (Median)
Avelumab and Cisplatin IVNA

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Proportion of Participants With Complete Response (At 6 Months)

"Patients enrolled will have non-measurable disease based on imaging at baseline. Patients will be assessed for a response after 6 months of treatment using the results of a biopsy and cytology test. A complete response (CR) is defined as having a negative biopsy and negative urine cytology at 6 months from registration after finishing of concurrent RT and immunotherapy. Imaging of abdomen and pelvis confirming no systemic disease within 4 weeks of cystoscopy will be completed.~The proportion of patients reporting a CR is reported here with confidence intervals for the true success proportion using the binomial distribution." (NCT03617913)
Timeframe: At 6 months from registration

Interventionproportion of participants (Number)
Avelumab and Cisplatin IV0.5

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Percentage of Participants Taking Narcotics

-95% confidence intervals will be calculated assuming a binomial distribution (NCT03621696)
Timeframe: 6 weeks after POAmCRT (approximately 90 days)

Interventionpercentage of participants (Number)
Arm 1: POAmCRT40
Arm 2: POAmRT20
Arm 3: POACRT75

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Mean Percent Weight Change

"Weight in kilograms will be collected weekly during radiation~The percent weight loss from the baseline is calculated at any post-baseline" (NCT03621696)
Timeframe: Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)

Interventionpercent of change (Mean)
Arm 1: POAmCRT-4.89
Arm 2: POAmRT-3.18
Arm 3: POACRT-10.11

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Disease Recurrence Rate

(NCT03621696)
Timeframe: 24 months post-treatment (approximately 27 months)

InterventionParticipants (Count of Participants)
Arm 1: POAmCRT2
Arm 2: POAmRT1
Arm 3: POACRT3

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Change in Serum Creatinine

(NCT03621696)
Timeframe: Baseline to 6 weeks after POAmCRT (approximately 90 days)

Interventionmg/dL (Mean)
Arm 1: POAmCRT0.03
Arm 2: POAmRT0.08
Arm 3: POACRT-0.19

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Acute Toxicity

Number (percentage) of patients with physician-reported acute G3+ GI, GU and heme toxicities (NCT03690921)
Timeframe: Acute physician reported toxicity from start of treatment 12 weeks post-treatment

InterventionParticipants (Count of Participants)
IMPT for Anal Cancer (Single Arm Trial)2

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Complete Response at 12 Weeks

Number (percentage) patients who achieved a complete clinical response of their disease by 12 weeks after chemoradiation. (NCT03690921)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
IMPT for Anal Cancer (Single Arm Trial)6

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Overall Survival at 24 Months

Patients alive 24 months after chemoradiation. (NCT03690921)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
IMPT for Anal Cancer (Single Arm Trial)7

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Distant Metastasis-free Survival at 24 Months.

Patients alive without evidence of distant metastases 24 months after chemoradiation. (NCT03690921)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
IMPT for Anal Cancer (Single Arm Trial)5

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Complete Response at 24 Weeks

Number (percentage) patients who achieved a complete clinical response of their disease by 24 weeks after chemoradiation. (NCT03690921)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
IMPT for Anal Cancer (Single Arm Trial)6

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Local Progression Free Survival at 24 Months

Patients alive without evidence of local progression 24 months after chemoradiation. (NCT03690921)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
IMPT for Anal Cancer (Single Arm Trial)5

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Overall Survival (OS)

Survival time is defined as the time from second step registration to the date of death, or last known follow-up (censored). Percentage of participants alive at a given time (OS) was to be estimated by the Kaplan-Meier method. Median OS and OS at specific time points was to be reported, with 95% confidence intervals, for each mutation/regimen combination. Due to early accrual closure resulting in few patients, only the number of participants who died are provided, by mutation, and no statistical testing was done. (NCT03737994)
Timeframe: Baseline to the date of death or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

,
InterventionParticipants (Count of Participants)
Mutation = I1171: deathsMutation = None: deaths
Brigatinib01
Lorlatinib00

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Overall Survival (OS)

Survival time is defined as the time from second step registration to the date of death, or last known follow-up (censored). Percentage of participants alive at a given time (OS) was to be estimated by the Kaplan-Meier method. Median OS and OS at specific time points was to be reported, with 95% confidence intervals, for each mutation/regimen combination. Due to early accrual closure resulting in few patients, only the number of participants who died are provided, by mutation, and no statistical testing was done. (NCT03737994)
Timeframe: Baseline to the date of death or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

InterventionParticipants (Count of Participants)
Mutation = None: deaths
Ensartinib2

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Overall Survival (OS)

Survival time is defined as the time from second step registration to the date of death, or last known follow-up (censored). Percentage of participants alive at a given time (OS) was to be estimated by the Kaplan-Meier method. Median OS and OS at specific time points was to be reported, with 95% confidence intervals, for each mutation/regimen combination. Due to early accrual closure resulting in few patients, only the number of participants who died are provided, by mutation, and no statistical testing was done. (NCT03737994)
Timeframe: Baseline to the date of death or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

InterventionParticipants (Count of Participants)
Mutation = I1171: deaths
LDK378 (Ceritinib)0

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Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria

"ORR= number of subjects with best overall response (BOR) of complete or partial response (CR, PR) divided by number of evaluable subjects. BOR= best response recorded from start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up.~CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes < 10mm.~PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions.~PD: 20% increase of target lesions and/or new lesion(s).~ORR was to be compared using Fisher's exact test within each ALK inhibitor treatment arm (each mutation vs. no mutation) and also within the subset of subjects with no mutation comparing each experimental arm vs. pemetrexed. Due to early accrual closure (few subjects), only the number of subjects with BOR of CR or PR are provided, by mutation, no statistical testing. Analysis was to occur after each patient was potentially followed ≥ 24 weeks." (NCT03737994)
Timeframe: Baseline to 24 weeks

,
InterventionParticipants (Count of Participants)
Mutation = I1171: BOR of CR or PRMutation = None: BOR of CR or PR
Brigatinib01
Lorlatinib12

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Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria

"ORR= number of subjects with best overall response (BOR) of complete or partial response (CR, PR) divided by number of evaluable subjects. BOR= best response recorded from start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up.~CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes < 10mm.~PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions.~PD: 20% increase of target lesions and/or new lesion(s).~ORR was to be compared using Fisher's exact test within each ALK inhibitor treatment arm (each mutation vs. no mutation) and also within the subset of subjects with no mutation comparing each experimental arm vs. pemetrexed. Due to early accrual closure (few subjects), only the number of subjects with BOR of CR or PR are provided, by mutation, no statistical testing. Analysis was to occur after each patient was potentially followed ≥ 24 weeks." (NCT03737994)
Timeframe: Baseline to 24 weeks

InterventionParticipants (Count of Participants)
Mutation = None: BOR of CR or PR
Ensartinib0

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Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria

"ORR= number of subjects with best overall response (BOR) of complete or partial response (CR, PR) divided by number of evaluable subjects. BOR= best response recorded from start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up.~CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes < 10mm.~PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions.~PD: 20% increase of target lesions and/or new lesion(s).~ORR was to be compared using Fisher's exact test within each ALK inhibitor treatment arm (each mutation vs. no mutation) and also within the subset of subjects with no mutation comparing each experimental arm vs. pemetrexed. Due to early accrual closure (few subjects), only the number of subjects with BOR of CR or PR are provided, by mutation, no statistical testing. Analysis was to occur after each patient was potentially followed ≥ 24 weeks." (NCT03737994)
Timeframe: Baseline to 24 weeks

InterventionParticipants (Count of Participants)
Mutation = I1171: BOR of CR or PR
LDK378 (Ceritinib)0

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Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1

"Duration of overall response (DOR) is defined as the time from the first occurrence of a documented BOR of CR or PR to the first date of recorded disease progression (PD) or death from any cause (whichever occurs first). BOR is the best response recorded from the start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up.~CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes < 10mm.~PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions.~PD: 20% increase of target lesions and/or new lesion(s).~Median DOR was to be estimated, with 95% confidence intervals, for each mutation/regimen combination using the Kaplan-Meier method. Due to early accrual closure resulting in few subjects, only the mean and range DOR are provided, by mutation, and no statistical testing was done." (NCT03737994)
Timeframe: Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

Interventionmonths (Mean)
Mutation = I1171Mutation = None
Lorlatinib27.919.2

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Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria

Progression-free survival time is defined as the time from second step registration to the date of the first disease progression / progressive disease (PD), death, or last known follow-up (censored). Progressive disease is defined as a 20% increase of target lesions and/or new lesion(s). Percentage of participants progression-free at a given time (PFS) was to be estimated by the Kaplan-Meier method. Median PFS and PFS at specific time points was to be reported, with 95% confidence intervals, for each mutation (or no mutation)/regimen combination. Due to early accrual closure resulting in few participants, only the number of participants who progressed or died, by mutation, with no statistical testing. (NCT03737994)
Timeframe: Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

InterventionParticipants (Count of Participants)
Mutation = none: progression or death
Ensartinib2

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Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1

"Duration of overall response (DOR) is defined as the time from the first occurrence of a documented BOR of CR or PR to the first date of recorded disease progression (PD) or death from any cause (whichever occurs first). BOR is the best response recorded from the start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up.~CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes < 10mm.~PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions.~PD: 20% increase of target lesions and/or new lesion(s).~Median DOR was to be estimated, with 95% confidence intervals, for each mutation/regimen combination using the Kaplan-Meier method. Due to early accrual closure resulting in few subjects, only the mean and range DOR are provided, by mutation, and no statistical testing was done." (NCT03737994)
Timeframe: Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

Interventionmonths (Mean)
Mutation = None
Brigatinib3.5

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Number of Participants by Highest Grade Adverse Event Reported

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. (NCT03737994)
Timeframe: Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

InterventionParticipants (Count of Participants)Participants (Count of Participants)
Mutation = I110772512695Mutation = I110772512697Mutation = I110772512700Mutation = none72512697Mutation = none72512695Mutation = none72512698
Grade 1Grade 2Grade 3Grade 4Grade 5
Lorlatinib1
LDK378 (Ceritinib)1
LDK378 (Ceritinib)0
Brigatinib0
Lorlatinib0
Lorlatinib2
Ensartinib3
Brigatinib1
Ensartinib0

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Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria

Progression-free survival time is defined as the time from second step registration to the date of the first disease progression / progressive disease (PD), death, or last known follow-up (censored). Progressive disease is defined as a 20% increase of target lesions and/or new lesion(s). Percentage of participants progression-free at a given time (PFS) was to be estimated by the Kaplan-Meier method. Median PFS and PFS at specific time points was to be reported, with 95% confidence intervals, for each mutation (or no mutation)/regimen combination. Due to early accrual closure resulting in few participants, only the number of participants who progressed or died, by mutation, with no statistical testing. (NCT03737994)
Timeframe: Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

,
InterventionParticipants (Count of Participants)
Mutation = I1107: progression or deathMutation = none: progression or death
Brigatinib11
Lorlatinib01

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Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria

Progression-free survival time is defined as the time from second step registration to the date of the first disease progression / progressive disease (PD), death, or last known follow-up (censored). Progressive disease is defined as a 20% increase of target lesions and/or new lesion(s). Percentage of participants progression-free at a given time (PFS) was to be estimated by the Kaplan-Meier method. Median PFS and PFS at specific time points was to be reported, with 95% confidence intervals, for each mutation (or no mutation)/regimen combination. Due to early accrual closure resulting in few participants, only the number of participants who progressed or died, by mutation, with no statistical testing. (NCT03737994)
Timeframe: Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months.

InterventionParticipants (Count of Participants)
Mutation = I1107: progression or death
LDK378 (Ceritinib)0

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Disease-free Survival (DFS) at 2 Years

Percentage of participants who survive disease-free at 2 years, where DFS is defined as the duration of time from study entry to date of first documented recurrence or progression of disease or death, whichever occurs first. Progression is assessed by RECIST 1.1.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT03738228)
Timeframe: Up to 2 years

InterventionPercentage of participants (Number)
Arm A68.4
Arm B52.9

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Post-treatment 3-month PET/CT Metabolic Response

Percentage of participants with complete post-treatment 3-month PET/CT metabolic response. The post-treatment 3-month PET/CT metabolic response is evaluated based on the ratio of post-treatment week-12 PET-CT SUVmax to base-line PET-CT scan SUV max, and the response will be classified as complete metabolic response for the ratio < 0.34, or classified as partial metabolic response for 0.34 <= the ratio < 0.76, or classified as stable metabolic response for 0.76 <= the ratio < 1.25, or classified as progressive metabolic disease for the ratio >= 1.25. (NCT03738228)
Timeframe: 3 months after completion of study treatment

InterventionPercentage of participants (Number)
Arm A71.4
Arm B50

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Immune Response

The immune response is measured by total T cell receptor beta (TCRB) clonal expansion in peripheral blood at day 21 from baseline using Adaptive Biotechnologies' immunoSEQ platform from Day -21 to Day 21 for group 1 (i.e., Arm A), and from Day 0 to Day 21 for group 2 (i.e., Arm B). The higher number of total TCR clonal expansion indicates better immune response. (NCT03738228)
Timeframe: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab

InterventionTotal number of expanded clones (Mean)
Arm A132.7
Arm B192.8

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Percentage of Participants With Dose Limiting Toxicities

A DLT is defined as any drug related adverse effects that occur during treatment period until 30 days after the completion of CRT and meet the criteria as evaluated by NCI CTCAE v.5 unless clearly unrelated to study therapy (e.g., disease progression). (NCT03738228)
Timeframe: Arm A: 111 days, i.e., from start of the priming dose of atezolizumab until 30 days after the completion of CRT Arm B: 90 days, i.e., from start of CRT until 30 days after the completion of CRT(Chemoradiation therapy).

InterventionPercentage of participants (Number)
Arm A0
Arm B21.43

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Pre-treatment PD-L1 Expression

Pre-treatment PD-L1 SP142 positive immune cells in tumor area in formalin-fixed paraffin-embedded (FFPE) biopsy primary tumor tissues (NCT03738228)
Timeframe: Within 3 days after randomization but before start of study treatment

Interventionpercentage of PDL-1 expression (Median)
Arm A0.75
Arm B0.5

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T Cell Receptor (TCR) Diversity

TCR diversity in peripheral blood is measured at day 21 by counting the number of unique rearrangements to a common number of T cells using Adaptive Biotechnologies' immunoSEQ platform. A higher TCR diversity indicates a richer TCR repertoire. (NCT03738228)
Timeframe: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab

Interventionnumber of unique rearrangements (Median)
Arm A12118
Arm B12237

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T Cell Receptor (TCR) Simpson Clonality

TCR Simpson clonality in peripheral blood is measured at day 21 using Adaptive Biotechnologies' immunoSEQ platform. It quantitates the extent of mono- or oligoclonal dominance within a TCR repertoire by measuring the shape of the clone frequency distribution ranging from 0 to 1, where values approaching 1 indicate a nearly monoclonal population. (NCT03738228)
Timeframe: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab

InterventionIndex (Median)
Arm A0.0505
Arm B0.0448

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Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v5.0. (NCT03738228)
Timeframe: Arm A: 111 days, i.e., from start of the priming dose of atezolizumab until 30 days after the completion of CRT Arm B 90 days, i.e., from start of CRT until 30 days after the completion of CRT

,
InterventionParticipants (Count of Participants)
Blood and lymphatic system disordersCardiac DisordersGastrointestinal DisordersGeneral disorders and administrative site conditionsInfections and InfestationsInvestigationsMetabolism and Nutrition DisordersMusculoskeletal and Connective Tissue DisordersRenal and Urinary DisordersReproductive System and Breast Disorders
Arm A4121320011
Arm B6040274202

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Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

"Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13.~Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration.~NA is not applicable. The upper confidence limit was not calculable because of an insufficient number of participants with events." (NCT03775486)
Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

,
Interventionmonths (Median)
EORTC QLQ-LC13: DyspnoeaEORTC QLQ-LC13: CoughingEORTC QLQ-LC13: HaemoptysisEORTC QLQ-LC13: Pain In ChestEORTC QLQ-LC13: Pain In Arm Or ShoulderEORTC QLQ-LC13: Pain In Other Parts
Durvalumab/Olaparib Combination Therapy10.011.715.013.815.010.3
Durvalumab/Placebo Therapy9.710.612.611.59.710.6

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Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

"Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented.~The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function.~A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems." (NCT03775486)
Timeframe: Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.

,
Interventionchange from baseline score (Mean)
EORTC QLQ-C30: FatigueEORTC QLQ-C30: Appetite loss
Durvalumab/Olaparib Combination Therapy0.15-0.13
Durvalumab/Placebo Therapy-1.49-3.35

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Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

"Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented.~The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity." (NCT03775486)
Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

,
Interventionchange from baseline score (Mean)
EORTC QLQ-LC13: DyspnoeaEORTC QLQ-LC13: CoughingEORTC QLQ-LC13: Pain in chest
Durvalumab/Olaparib Combination Therapy-1.27-2.141.31
Durvalumab/Placebo Therapy-0.76-3.093.57

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Concentration of Durvalumab

Concentration (pharmacokinetics) of durvalumab (NCT03775486)
Timeframe: Assessed from start of initial therapy up to 2 years.

,
Interventionμg/mL (Geometric Mean)
Cycle 01 Day 01 (Initial Therapy Phase) Post doseCycle 02 Day 01 (Initial Therapy Phase) Pre doseCycle 04 Day 01 (Initial Therapy Phase) Pre doseCycle 01 (Maintenance Phase) Post doseCycle 02 (Maintenance Phase) Pre doseCycle 05 (Maintenance Phase) Pre doseCycle 08 (Maintenance Phase) Pre doseCycle 11 (Maintenance Phase) Pre doseCycle 14 (Maintenance Phase) Pre doseCycle 17 (Maintenance Phase) Pre doseCycle 20 (Maintenance Phase) Pre doseMonth 03 (Maintenance Phase) Pre dose
Durvalumab/Olaparib Combination Therapy417.15276.812155.461535.078159.157166.644198.932210.794276.612264.096528.04612.289
Durvalumab/Placebo Therapy453.72476.959154.947524.306160.315147.848154.057186.092182.042217.137112.27612.769

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Duration of Response

"Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression.~Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method." (NCT03775486)
Timeframe: From date of first documented response until objective radiological disease progression or death, up to 18 months.

,
Interventionpercent (Number)
Percentage of participants remaining in response at 3 monthsPercentage of participants remaining in response at 6 monthsPercentage of participants remaining in response at 9 monthsPercentage of participants remaining in response at 12 months
Durvalumab/Olaparib Combination Therapy90.579.169.269.2
Durvalumab/Placebo Therapy85.165.765.765.7

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Overall Survival

"Overall survival (OS) across the maintenance phase.~OS is defined as time from date of randomization until the date of death by any cause" (NCT03775486)
Timeframe: From randomization until the date of death due to any cause, up to 18 months.

,
InterventionParticipants (Count of Participants)
DeathCensored participants (still in survival at follow up or terminated study prior to death)
Durvalumab/Olaparib Combination Therapy4490
Durvalumab/Placebo Therapy4590

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Presence of Anti-drug Antibodies (ADAs) for Durvalumab

Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab (NCT03775486)
Timeframe: Assessed from start of initial therapy up to 2 years.

,
InterventionParticipants (Count of Participants)
ADA prevalence (any ADA positive, baseline or post-baseline)ADA incidence (treatment-induced or treatment-boosted)ADA positive post-baseline and positive at baselineADA positive post-baseline and not detected at baseline (treatment-induced)ADA not detected at post-baseline and positive at baselineTreatment-boosted ADAPersistent positiveTransient positiveNeutralizing anti-drug antibody positive at any visit
Durvalumab/Olaparib Combination Therapy1150560051
Durvalumab/Placebo Therapy941440321

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Progression-free Survival

"Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1.~PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression)." (NCT03775486)
Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

,
InterventionParticipants (Count of Participants)
RECIST progression: Target LesionsRECIST progression: Non Target LesionsRECIST progression: New LesionsDeath in the absence of progressionCensored subjects: Censored RECIST progressionCensored subjects: Censored deathCensored subjects: Progression-free at time of analysisCensored subjects: Progression-free prior to lost to follow-upCensored subjects: Progression-free prior to withdrawal of consentCensored subjects: Progression-free prior to discontinuation due to other reasonCensored subjects: No post-baseline evaluable tumor assessment
Durvalumab/Olaparib Combination Therapy402844801440302
Durvalumab/Placebo Therapy633039900340202

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Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

"Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30.~NA is not applicable. The upper confidence limit was not calculable because of an insufficient number of participants with events." (NCT03775486)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, up to 18 months.

,
Interventiontime to deterioration (months) (Median)
EORTC QLQ-C30: FatigueEORTC QLQ-C30: Nausea And VomitingEORTC QLQ-C30: PainEORTC QLQ-C30: DyspnoeaEORTC QLQ-C30: InsomniaEORTC QLQ-C30: Appetite LossEORTC QLQ-C30: ConstipationEORTC QLQ-C30: DiarrhoeaPhysical FunctioningRole FunctioningEmotional FunctioningCognitive FunctioningSocial FunctioningGlobal Health Status/Quality of Life
Durvalumab/Olaparib Combination Therapy8.812.210.212.213.811.712.213.812.010.012.210.29.310.2
Durvalumab/Placebo Therapy1012.69.711.010.611.512.011.512.010.611.010.610.09.7

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Response Rate

Per the revised INRC, response is comprised by responses in 3 components: primary tumor, soft tissue and bone metastases, and bone marrow. Primary and metastatic soft tissue sites were assessed using Response Evaluation Criteria in Solid Tumors and MIBG scans or FDG-PET scans if the tumor was MIBG non-avid. Bone marrow was assessed by histology or immunohistochemistry and cytology or immunocytology. Complete response (CR) - All components meet criteria for CR. Partial response (PR) - PR in at least one component and all other components are either CR, minimal disease (in bone marrow), PR (soft tissue or bone) or not involved (NI; no component with progressive disease (PD). Minor response (MR) - PR or CR in at least one component but at least one other component with stable disease; no component with PD. Stable disease (SD) - Stable disease in one component with no better than SD or NI in any other component; no component with PD. Progressive disease (PD) - Any component with PD. (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment

InterventionPercentage of patients (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)78.6

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Event-free Survival

Per the revised INRC, progressive disease is: 1) > 20% increase in the longest diameter of the primary tumor, taking as reference the smallest sum and ¬> increase of 5 mm in longest dimension, 2) Any new soft tissue lesion detected by CT/MRI that is MIBG avid or FDG-PET avid, 3) Any new soft tissue lesion seen on CT/MRI that is biopsied and found to be neuroblastoma or ganglioneuroblastoma, 4) Any new bone site that is MIBG avid, 5) Any new bone site that is FDG-PET avid and has CT/MRI findings of tumor or is histologically neuroblastoma or ganglioneuroblastoma 6) A metastatic soft tissue site with > 20% increase in longest diameter, taking as reference the smallest sum on study, and with > 5mm in sum of diameters of target soft tissue lesions, 7) A relative MIBG score ¬> 1.2, 8) Bone marrow without tumor infiltration that becomes >5% tumor infiltration, 9) Bone marrow with tumor infiltration that increases by > 2-fold and has > 20% tumor infiltration on reassessment. (NCT03786783)
Timeframe: Up to 1 year

InterventionPercent Probability (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)82.6

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"Percentage of Participants Who Are Feasibility Failure"

"Feasibility failures were defined as patients that did not receive >= 75% of the planned dinutuximab doses during Induction cycles 3-5. Assessed by estimation of the feasibility failure rate together with a 95% confidence interval." (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment

InterventionPercentage of patients (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)0.0

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Percentage of Participants With Unacceptable Toxicity

Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Assessed by estimation of the combined toxic death and unacceptable toxicity rate during Induction cycles 3-5 together with a 95% confidence interval. (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment

Interventionpercentage of patients (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)0.0

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Overall Survival

Kaplan-Meier method was used to estimate overall survival (OS). OS was defined as the time from study enrollment to death. 1-year OS is provided. (NCT03786783)
Timeframe: Up to 1 year

InterventionPercent Probability (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)95.0

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Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment

"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate." (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Safety Population71994742Per Protocol Population71994742By Treatment Cycle Population71994742
Responders, Central ReviewerNon-Responders, Central Reviewer
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg41
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg12
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg30
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg21

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Overall (Objective) Response Rate (ORR), Local Reader's Assessment

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg8

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Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment

"Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.~(CR) + partial response (PR) at Months 6" (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7

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Overall (Objective) Response Rate, Local Read

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6. (NCT03790111)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg6

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Median Progression Free Survival

Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. (NCT03790111)
Timeframe: Month 12

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg6.233

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Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA) (NCT03790111)
Timeframe: Month 6

Interventionmicrograms/Liter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-1.735

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Overall (Objective) Response Rate, Central Radiologist's Assessment

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7

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Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA) (NCT03790111)
Timeframe: Month 12

Interventionmicrograms/Liter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-5.608

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Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA) (NCT03790111)
Timeframe: End of Study as defined up to 24 months

Interventionmicrograms/Liter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg4.154

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Disease Control Rate End of Study, Local Reviewer

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg40

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Disease Control Rate (DCR), Local Reviewer

Disease control rate (DCR), Local Reviewer, 6 Months (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg40

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Disease Control Rate (DCR), Local Reviewer

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: Month 12 as defined by 1 year

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg40

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Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment

Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12. (NCT03790111)
Timeframe: Month 12

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7

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Disease Control Rate (DCR), Central Radiologist's Assessment

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: End of Study up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg35

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Disease Control Rate (DCR), Central Radiologist's Assessment

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.." (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg33

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Change From Baseline in Serum Albumin

Mean change from Baseline to Month 6 serum albumin levels (NCT03790111)
Timeframe: Month 6

Interventiong/L (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-0.2

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Change From Baseline in Serum Albumin

Mean change from Baseline to Month 12 serum albumin levels (NCT03790111)
Timeframe: Month 12

Interventiong/L (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-2.2

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Change From Baseline in Serum Albumin

Mean change from Baseline to End of Study serum albumin levels (NCT03790111)
Timeframe: End of Study as defined up to 24 months

Interventiong/L (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-1.2

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Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)

Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9) (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionUnits per milliliter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-153.98

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Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)

Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9) (NCT03790111)
Timeframe: Month 6

InterventionU/mL (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-229.82

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Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)

Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9) (NCT03790111)
Timeframe: Month 12

InterventionU/mL (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-18.04

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Progression Free Survival, Local Radiologist's Assessment

Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. (NCT03790111)
Timeframe: Month 12

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7.467

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Project Overall Survival Rate at Month 12

Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12. (NCT03790111)
Timeframe: 12 Months

InterventionProportion of participants (Number)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg0.60

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Disease Control Rate (DCR), Central Radiologist's Assessment

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: Month 12

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg33

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Project Overall Survival Rate at Month 6

Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6. (NCT03790111)
Timeframe: 6 Months

InterventionProportion of participants (Number)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg0.87

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Summary of Duration of Progression Free Survival, Local Radiologist's Assessment

Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months. (NCT03790111)
Timeframe: up to 7 months

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7.000

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Weight Change From Baseline

Mean change in weight at Month 12 from baseline measurement (NCT03790111)
Timeframe: Month 12

Interventionkg (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg1.69

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Weight Change From Baseline

Mean change in weight at Month 6 from baseline measurement (NCT03790111)
Timeframe: Month 6

Interventionkg (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-0.69

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Overall (Objective) Response Rate, Local Reader's Assessment

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12. (NCT03790111)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg8

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Overall Survival (OS)

Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause. (NCT03790111)
Timeframe: First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg17.667

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Progression Free Survival, Local Radiologist's Assessment

Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7.467

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Weight Change From Baseline

Mean change in weight from baseline to End of Study (NCT03790111)
Timeframe: End of Study as defined up to 24 months

Interventionkg (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-3.28

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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR, or death due to any cause, whichever occurred first. (NCT04003636)
Timeframe: Up to approximately 26 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)6.5
Arm B (Placebo+Gemcitabine+Cisplatin)5.6

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Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)138
Arm B (Placebo+Gemcitabine+Cisplatin)122

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Number of Participants Who Experience One or More Adverse Events (AE)

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)524
Arm B (Placebo+Gemcitabine+Cisplatin)532

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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. (NCT04003636)
Timeframe: Up to approximately 26 months

InterventionPercentage of Participants (Number)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)28.7
Arm B (Placebo+Gemcitabine+Cisplatin)28.5

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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

For participants who demonstrate a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)9.7
Arm B (Placebo+Gemcitabine+Cisplatin)6.9

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Overall Survival (OS)

Overall survival was defined as the time from randomization to death due to any cause. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)12.7
Arm B (Placebo+Gemcitabine+Cisplatin)10.9

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the Maximum Tolerated Dose (MTD)

The primary endpoint was the MTD of anlotinib, at which less than 33% of patients experienced a DLT in the frst treatment cycle. A DLT involving hematological toxicity was defned as grade 4 and above, non-hematological toxicity as grade 3 and above, and liver and kidney function injury as grade 2 and above. (NCT04012619)
Timeframe: 1 month

Interventionmg (Number)
Anlotinib Hydrochloride Combined With AP10

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Frequency and Severity of Pneumonitis

The primary toxicity of interest is grade 3 or higher pneumonitis. The incidence of grade 3 or worse pneumonitis attributable to treatment will be evaluated and compared against the PACIFIC trial results. All toxicities of all grades will be monitored on study and reported. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as toxicity. (NCT04372927)
Timeframe: Through study completion (up to 4 months)

Interventionparticipants (Number)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)1

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Frequency of Adverse Events

Frequency and severity of toxicities will be graded with Common Terminology Criteria for Adverse Events (CTCAE), version 5. Toxicities will be summarized as the proportion of patients with such toxicities, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients. All toxicities of all grades will be monitored on study and reported. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as toxicity. (NCT04372927)
Timeframe: Through study completion (up to 4 months)

Interventionparticipants (Number)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)1

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Overall Survival (OS)

Will be evaluated using the method of Kaplan-Meier. Confidence intervals for median times will be determined using the Brookmeyer-Crowley method. Confidence intervals around landmark times will be determined using Greenwood's formula for the variance and based on a log-log transformation applied on the survival function. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as response. Means and/or medians will be calculated for continuous outcomes. Confidence bounds will be provided for means and quartiles and ranges for median values. All confidence bounds will be presented as 95% bounds. (NCT04372927)
Timeframe: From study registration to death due to any cause

Interventionmonths (Mean)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)4

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Response Rate

Will be evaluated using the method of Kaplan-Meier. Confidence intervals for median times will be determined using the Brookmeyer-Crowley method. Confidence intervals around landmark times will be determined using Greenwood's formula for the variance and based on a log-log transformation applied on the survival function. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as response. Means and/or medians will be calculated for continuous outcomes. Confidence bounds will be provided for means and quartiles and ranges for median values. All confidence bounds will be presented as 95% bounds. (NCT04372927)
Timeframe: Through study completion (up to 4 months)

Interventionparticipants (Number)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)0

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Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR

Progression-free survival was defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurred first. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)5.6
Arm B (Placebo+Gemcitabine+Cisplatin)5.7

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Overall Survival (OS)

Overall survival was defined as the time from randomization to death due to any cause. Per protocol the final reported outcome for OS did not include any sensitivity or supportive analysis. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)14.1
Arm B (Placebo+Gemcitabine+Cisplatin)9.9

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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionPercentage (Number)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)36.0
Arm B (Placebo+Gemcitabine+Cisplatin)28.9

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Number of Participants Who Experience One or More Adverse Events (AE)

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)73
Arm B (Placebo+Gemcitabine+Cisplatin)82

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Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)18
Arm B (Placebo+Gemcitabine+Cisplatin)14

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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

For participants who demonstrated a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)10.2
Arm B (Placebo+Gemcitabine+Cisplatin)5.7

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