Trial | Phase | Enrollment | Study Type | Start Date | Status |
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 2 | 44 participants (Actual) | Interventional | 2005-10-31 | Completed |
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) | Interventional | 2011-07-06 | Active, 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 3 | 613 participants (Anticipated) | Interventional | 2013-03-22 | Recruiting |
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 2 | 130 participants (Anticipated) | Interventional | 2023-05-30 | Not yet recruiting |
Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol - The PIPAC-OPC2 Trial [NCT03287375] | Phase 2 | 143 participants (Actual) | Interventional | 2016-12-01 | Completed |
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 3 | 784 participants (Anticipated) | Interventional | 2021-04-21 | Active, 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in Intensity-modulated Radiotherapy Era [NCT02289807] | | 0 participants (Actual) | Interventional | 2015-03-31 | Withdrawn |
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas [NCT00047008] | Phase 3 | 743 participants (Actual) | Interventional | 2002-07-31 | Completed |
Phase II Trial of Cisplatin Combined With Oral TS-1 in Patients With Advanced Solid Tumors With Different Degrees of Liver Dysfunction [NCT03519074] | Phase 2 | 48 participants (Anticipated) | Interventional | 2016-07-22 | Recruiting |
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 1 | 8 participants (Actual) | Interventional | 2009-09-03 | Completed |
A Retrospective Study of Extremity Osteosarcoma Patients Who Recieved Intra-arterial Limb Infusion of Cisplatin During Neoadjuvant Chemotherapy [NCT03909776] | | 99 participants (Actual) | Interventional | 2019-01-01 | Completed |
Randomized Phase II Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer [NCT01283204] | Phase 2 | 180 participants (Actual) | Interventional | 2010-03-09 | Completed |
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 2 | 49 participants (Actual) | Interventional | 2015-04-14 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2011-01-31 | Withdrawn(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 3 | 111 participants (Actual) | Interventional | 2006-02-20 | Completed |
Panitumumab in Combination With Cisplatin/Gemcitabine Chemotherapy in Patients With Cholangiocarcinomas - a Randomized Clinical Phase II Study [NCT01320254] | Phase 2 | 93 participants (Actual) | Interventional | 2011-06-30 | Completed |
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 2 | 68 participants (Anticipated) | Interventional | 2023-12-05 | Not yet recruiting |
A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC) [NCT06064097] | Phase 2 | 50 participants (Anticipated) | Interventional | 2023-12-20 | Not yet recruiting |
Phase II Study of Bladder-SparIng ChemoradiatioN With Durvalumab in Clinical Stage III, Node PosItive BladdeR CancEr (INSPIRE) [NCT04216290] | Phase 2 | 95 participants (Anticipated) | Interventional | 2021-03-17 | Active, 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 3 | 660 participants (Anticipated) | Interventional | 2020-04-29 | Active, 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 2 | 160 participants (Actual) | Interventional | 2018-05-02 | Active, 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 2 | 333 participants (Anticipated) | Interventional | 2016-09-15 | Active, 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 1 | 22 participants (Actual) | Interventional | 2019-09-18 | Active, 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 2 | 117 participants (Actual) | Interventional | 2010-03-15 | Active, 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 3 | 403 participants (Actual) | Interventional | 2008-08-08 | Active, 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 1 | 33 participants (Actual) | Interventional | 2009-02-25 | Completed |
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 2 | 70 participants (Actual) | Interventional | 2010-10-31 | Terminated(stopped due to insufficient recruitment) |
Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer [NCT01375972] | Phase 2 | 92 participants (Actual) | Interventional | 2008-03-31 | Completed |
A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer [NCT01230996] | Phase 1/Phase 2 | 22 participants (Actual) | Interventional | 2010-07-31 | Completed |
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 2 | 30 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
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 2 | 156 participants (Actual) | Interventional | 2012-09-28 | Completed |
Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer [NCT03366766] | Phase 2 | 14 participants (Actual) | Interventional | 2017-12-20 | Completed |
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 2 | 88 participants (Actual) | Interventional | 2009-07-31 | Completed |
A Single Institutional Phase II Clinical Trial of Abraxane Combined With Cisplatin in Metastatic Breast Cancer [NCT01149798] | Phase 2 | 73 participants (Actual) | Interventional | 2010-06-30 | Completed |
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 3 | 380 participants (Anticipated) | Interventional | 2023-12-31 | Not 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 2 | 75 participants (Anticipated) | Interventional | 2023-05-31 | Not 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 2 | 120 participants (Actual) | Interventional | 2014-04-21 | Active, 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 1 | 37 participants (Actual) | Interventional | 2011-03-14 | Completed |
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 2 | 6 participants (Actual) | Interventional | 2009-09-30 | Completed |
INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN. [NCT01285674] | | 20 participants (Anticipated) | Interventional | 2011-01-31 | Not 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 3 | 334 participants (Anticipated) | Interventional | 2019-06-11 | Recruiting |
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 2 | 84 participants (Actual) | Interventional | 2010-05-31 | Completed |
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 1 | 45 participants (Anticipated) | Interventional | 2011-04-04 | Active, 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 3 | 222 participants (Actual) | Interventional | 2012-04-30 | Terminated |
A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer [NCT01198392] | Phase 3 | 270 participants (Anticipated) | Interventional | 2008-09-30 | Recruiting |
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 1 | 24 participants (Actual) | Interventional | 2011-01-31 | Completed |
Phase II Study of Patients With Peritoneal Carcinomatosis From Gastric Cancer Treated With Preoperative Systemic Chemotherapy Followed by Peritonectomy and Intraperitoneal Chemotherapy [NCT01379482] | Phase 2 | 18 participants (Actual) | Interventional | 2005-01-31 | Completed |
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 2 | 103 participants (Actual) | Interventional | 2019-06-28 | Active, 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 3 | 513 participants (Actual) | Interventional | 2003-05-31 | Completed |
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 3 | 1,381 participants (Actual) | Interventional | 2003-08-25 | Completed |
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma [NCT01327521] | Phase 3 | 0 participants (Actual) | Interventional | 2011-02-28 | Withdrawn(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 2 | 100 participants (Anticipated) | Interventional | 2019-05-22 | Recruiting |
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 2 | 60 participants (Anticipated) | Interventional | 2010-06-30 | Not 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 3 | 610 participants (Actual) | Interventional | 1994-07-31 | Completed |
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 2 | 5 participants (Actual) | Interventional | 2011-12-31 | Active, 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 1 | 6 participants (Actual) | Interventional | 2009-12-31 | Completed |
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 3 | 166 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients [NCT02036164] | Phase 3 | 500 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
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 3 | 165 participants (Anticipated) | Interventional | 2023-09-22 | Not 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 2 | 80 participants (Anticipated) | Interventional | 2011-02-28 | Recruiting |
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 3 | 1,005 participants (Actual) | Interventional | 2019-06-28 | Active, 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 3 | 538 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
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 2 | 12 participants (Actual) | Interventional | 2016-10-11 | Terminated(stopped due to bussiness reason) |
Study of Pd-1 Antibody in Combination With Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer [NCT04516616] | Phase 2 | 82 participants (Anticipated) | Interventional | 2020-12-01 | Recruiting |
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes and Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma [NCT02421640] | Phase 2 | 116 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting |
Induction Chemotherapy and Toripalimab Followed by Surgery or Radiotherapy for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma [NCT04995120] | Phase 2 | 42 participants (Anticipated) | Interventional | 2021-04-07 | Recruiting |
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 1 | 13 participants (Actual) | Interventional | 2010-08-31 | Terminated(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) | Interventional | 2015-03-31 | Recruiting |
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 2 | 25 participants (Anticipated) | Interventional | 2022-03-09 | Recruiting |
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) [NCT02072148] | | 112 participants (Actual) | Interventional | 2014-03-31 | Completed |
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 2 | 70 participants (Anticipated) | Interventional | 2023-06-23 | Recruiting |
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 3 | 230 participants (Anticipated) | Interventional | 2023-12-11 | Not yet recruiting |
Phase I/Ib Study of AKT Inhibitor Ipatasertib With Chemoradiation for Locally Advanced Head and Neck Cancer [NCT05172245] | Phase 1 | 46 participants (Anticipated) | Interventional | 2022-09-19 | Recruiting |
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Using Cisplatin, Mitomycin, and Adriamycin in Peritoneal Surface Malignancies Also Known as Hyperthermic Intraperitoneal Chemotherapy. [NCT02349958] | Phase 2 | 200 participants (Anticipated) | Interventional | 2006-09-30 | Recruiting |
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 1 | 23 participants (Actual) | Interventional | 2014-09-29 | Completed |
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 3 | 380 participants (Anticipated) | Interventional | 2022-03-29 | Recruiting |
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 2 | 91 participants (Actual) | Interventional | 2016-08-23 | Active, 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 2 | 76 participants (Anticipated) | Interventional | 2017-05-04 | Recruiting |
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 2 | 116 participants (Anticipated) | Interventional | 2018-12-31 | Not yet recruiting |
Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer [NCT03769935] | Phase 2 | 90 participants (Actual) | Interventional | 2017-01-01 | Completed |
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] | 2014-05-31 | Not 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 3 | 16 participants (Actual) | Interventional | 2020-01-29 | Terminated(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 1 | 40 participants (Actual) | Interventional | 2019-01-07 | Active, 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 1 | 10 participants (Actual) | Interventional | 2018-05-29 | Active, 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 2 | 34 participants (Actual) | Interventional | 2019-01-30 | Active, 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 2 | 0 participants (Actual) | Interventional | 2011-03-31 | Withdrawn(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 2 | 72 participants (Actual) | Interventional | 2017-01-20 | Completed |
A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer [NCT01348009] | Phase 1/Phase 2 | 63 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting |
Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients [NCT00392327] | Phase 3 | 379 participants (Actual) | Interventional | 2007-03-26 | Active, 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 2 | 76 participants (Anticipated) | Interventional | 2011-03-31 | Active, not recruiting |
Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury [NCT02250872] | Phase 2/Phase 3 | 182 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
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 2 | 20 participants (Anticipated) | Interventional | 2023-04-10 | Recruiting |
A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology [NCT02891447] | Phase 2 | 24 participants (Actual) | Interventional | 2016-09-01 | Completed |
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 2 | 100 participants (Anticipated) | Interventional | 2021-02-01 | Recruiting |
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 2 | 33 participants (Anticipated) | Interventional | 2023-02-18 | Recruiting |
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 2 | 99 participants (Actual) | Interventional | 2015-01-01 | Completed |
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 2 | 61 participants (Actual) | Interventional | 2017-05-12 | Active, 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 3 | 188 participants (Actual) | Interventional | 2005-08-31 | Completed |
Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer [NCT02182778] | Phase 3 | 246 participants (Actual) | Interventional | 2014-07-09 | Completed |
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 3 | 953 participants (Actual) | Interventional | 2015-11-03 | Active, 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 1 | 11 participants (Actual) | Interventional | 2010-01-18 | Terminated(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 2 | 195 participants (Actual) | Interventional | 2010-08-31 | Completed |
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 2 | 80 participants (Anticipated) | Interventional | 2008-03-31 | Active, 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 3 | 442 participants (Actual) | Interventional | 2004-12-31 | Completed |
A Pilot Study of Chemoradiotherapy Plus Temsirolimus (Torisel) for Advanced Head and Neck Cancer [NCT01326468] | | 0 participants (Actual) | Interventional | 2011-01-31 | Withdrawn(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 2 | 61 participants (Actual) | Interventional | 2005-01-31 | Completed |
A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer [NCT00394433] | Phase 2 | 38 participants (Actual) | Interventional | 2006-09-30 | Completed |
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 2 | 1 participants (Actual) | Interventional | 2010-02-28 | Terminated(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 3 | 334 participants (Actual) | Interventional | 2018-07-23 | Completed |
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 2 | 200 participants (Anticipated) | Interventional | 2022-04-06 | Recruiting |
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 1 | 26 participants (Anticipated) | Interventional | 2023-06-21 | Recruiting |
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 3 | 730 participants (Actual) | Interventional | 2020-08-07 | Active, 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 1 | 8 participants (Actual) | Interventional | 2021-01-25 | Active, 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 2 | 18 participants (Actual) | Interventional | 2017-07-31 | Active, not recruiting |
Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer [NCT01504815] | Phase 3 | 268 participants (Actual) | Interventional | 2012-03-31 | Active, not recruiting |
Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial [NCT00003907] | Phase 2 | 50 participants (Actual) | Interventional | 1999-12-15 | Completed |
Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer [NCT01097252] | Phase 3 | 104 participants (Actual) | Interventional | 2002-01-31 | Completed |
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 2 | 20 participants (Actual) | Interventional | 2018-03-09 | Completed |
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 2 | 460 participants (Anticipated) | Interventional | 2017-09-01 | Recruiting |
Primary Surgery Vs Primary Chemoradiation for Oropharyngeal Cancer (Scope Trial) - A Phase II/III Integrated Design Randomized Control Trial [NCT05144100] | Phase 2/Phase 3 | 498 participants (Anticipated) | Interventional | 2021-12-01 | Not yet recruiting |
Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy [NCT02492360] | | 0 participants (Actual) | Observational | 2017-12-31 | Withdrawn(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 2 | 160 participants (Anticipated) | Interventional | 2014-05-31 | Recruiting |
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 2 | 46 participants (Anticipated) | Interventional | 2023-12-15 | Not yet recruiting |
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study [NCT05857631] | | 90 participants (Anticipated) | Interventional | 2023-05-29 | Recruiting |
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial [NCT04473716] | Phase 1 | 20 participants (Actual) | Interventional | 2020-07-30 | Completed |
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 3 | 826 participants (Actual) | Interventional | 2018-12-06 | Active, not recruiting |
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years [NCT01096368] | Phase 3 | 479 participants (Actual) | Interventional | 2010-05-07 | Active, 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 2 | 29 participants (Actual) | Interventional | 2006-06-15 | Active, 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 3 | 160 participants (Anticipated) | Interventional | 2007-09-30 | Active, not recruiting |
Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma [NCT01029873] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2010-02-28 | Completed |
Four Cycles of Cisplatin-Based Chemotherapy in Metastatic Urothelial Carcinoma Compared to Six Cycles: Randomized Phase III Trial - FOCUS Study - [NCT03296306] | Phase 3 | 330 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
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 1 | 72 participants (Anticipated) | Interventional | 2014-05-31 | Active, 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 2 | 48 participants (Anticipated) | Interventional | 2017-06-27 | Recruiting |
Phase I /II Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma [NCT02446574] | Phase 1/Phase 2 | 33 participants (Actual) | Interventional | 2007-07-31 | Completed |
A Phase 1 Study of COTI-2 as Monotherapy or Combination Therapy for the Treatment of Advanced or Recurrent Malignancies [NCT02433626] | Phase 1 | 51 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting |
Phase â…¡ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis [NCT02291211] | Phase 2 | 60 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer [NCT02435186] | Phase 2 | 100 participants (Anticipated) | Interventional | 2015-06-30 | Not 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 2 | 90 participants (Anticipated) | Interventional | 2015-06-30 | Not 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 4 | 500 participants (Anticipated) | Interventional | 2017-10-06 | Recruiting |
A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas [NCT04620187] | Phase 2 | 55 participants (Anticipated) | Interventional | 2020-12-24 | Recruiting |
Cisplatin Combined With Irinotecan or Etoposide for Untreated Extensive-stage Small Cell Lung Cancer: a Multicenter Randomized Control Clinical Trial [NCT02323737] | Phase 2 | 62 participants (Actual) | Interventional | 2010-07-31 | Completed |
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 2 | 26 participants (Actual) | Interventional | 2018-04-27 | Active, not recruiting |
Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients With Newly Diagnosed High-Risk Neuroblastoma [NCT01798004] | Phase 1 | 150 participants (Actual) | Interventional | 2013-04-08 | Active, 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 1 | 99 participants (Actual) | Interventional | 2010-10-04 | Active, 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 2 | 156 participants (Actual) | Interventional | 2007-03-15 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2018-08-15 | Withdrawn(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 1 | 34 participants (Actual) | Interventional | 2016-08-23 | Completed |
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 2 | 50 participants (Actual) | Interventional | 2013-04-30 | Completed |
Sequential Chemoradiotherapy With Reduced Target Delineation and Radiation Doses During Radiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03389295] | Phase 2 | 118 participants (Actual) | Interventional | 2010-01-31 | Completed |
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 3 | 32 participants (Anticipated) | Interventional | 2012-02-29 | Recruiting |
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 2 | 70 participants (Actual) | Interventional | 2008-12-31 | Completed |
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 2 | 140 participants (Actual) | Interventional | 2004-07-14 | Completed |
"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 2 | 28 participants (Anticipated) | Interventional | 2020-09-28 | Recruiting |
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 2 | 14 participants (Actual) | Interventional | 2012-06-30 | Completed |
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 3 | 669 participants (Actual) | Interventional | 2017-01-02 | Active, not recruiting |
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer [NCT00337532] | Phase 2/Phase 3 | 50 participants | Interventional | 2005-05-31 | Completed |
Phase III Randomized Trial of HIPEC in Primary Stage Three & Four Ovarian Cancer After Interval Cytoreductive Surgery (FOCUS) [NCT05827523] | Phase 3 | 520 participants (Anticipated) | Interventional | 2023-05-31 | Recruiting |
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 2 | 1 participants (Actual) | Interventional | 2020-01-14 | Terminated(stopped due to low enrollment) |
Implementation and Evaluation of PIPAC for the Treatment of Patients With Peritoneal Carcinomatosis - a Feasibility Study. [NCT02320448] | Phase 2 | 35 participants (Actual) | Interventional | 2015-03-31 | Completed |
Cisplatin Based Regimen to Patients With Advanced Pancreatic Cancer and Homologous Recombination Deficiency [NCT06095141] | Phase 2/Phase 3 | 30 participants (Anticipated) | Interventional | 2023-12-01 | Recruiting |
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 2 | 180 participants (Anticipated) | Interventional | 2024-01-10 | Not 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 1 | 45 participants (Anticipated) | Interventional | 2017-04-17 | Active, 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 3 | 50 participants (Anticipated) | Interventional | 2022-01-10 | Recruiting |
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 2 | 189 participants (Anticipated) | Interventional | 2016-11-23 | Recruiting |
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 3 | 663 participants (Actual) | Interventional | 2021-06-23 | Active, 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 3 | 1,100 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
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 2 | 67 participants (Actual) | Interventional | 2017-12-21 | Terminated(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 3 | 290 participants (Anticipated) | Interventional | 2021-05-31 | Not yet recruiting |
Phase III Clinical Trial of Intravenous Paclitaxel Plus Intraperitoneal Cisplatin for Neo-adjuvant Chemotherapy in Patients With Advanced Ovarian Cancer [NCT04885270] | Phase 3 | 50 participants (Anticipated) | Interventional | 2021-08-04 | Recruiting |
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 2 | 99 participants (Anticipated) | Interventional | 2018-07-22 | Active, 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 3 | 1,118 participants (Actual) | Interventional | 2015-07-21 | Active, 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 1 | 91 participants (Actual) | Interventional | 2020-03-27 | Active, not recruiting |
Clinical Study of Adbelizumab Combined With Concurrent Chemoradiotherapy in Locally Advanced Cervical Cancer [NCT06149767] | Phase 2 | 26 participants (Anticipated) | Interventional | 2024-01-31 | Not 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 3 | 140 participants (Anticipated) | Interventional | 2023-08-16 | Recruiting |
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 2 | 22 participants (Anticipated) | Interventional | 2023-06-30 | Recruiting |
A Prospective Study of Dynamic Monitoring Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy [NCT03559803] | | 58 participants (Actual) | Interventional | 2016-10-31 | Active, 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 2 | 171 participants (Actual) | Interventional | 2007-12-31 | Completed |
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) | Interventional | 2011-08-24 | Terminated(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 2 | 50 participants (Anticipated) | Interventional | 2023-04-30 | Not yet recruiting |
Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors [NCT01014598] | Phase 1 | 11 participants (Actual) | Interventional | 2007-12-04 | Completed |
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 2 | 20 participants (Anticipated) | Interventional | 2021-03-08 | Recruiting |
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 3 | 839 participants (Actual) | Interventional | 2005-11-30 | Terminated(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) | Observational | 2019-03-10 | Completed |
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 2 | 48 participants (Actual) | Interventional | 2018-07-12 | Completed |
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 2 | 19 participants (Actual) | Interventional | 2005-01-12 | Completed |
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 2 | 50 participants (Actual) | Interventional | 2013-09-30 | Completed |
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 3 | 632 participants (Anticipated) | Interventional | 2018-06-30 | Not yet recruiting |
A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer [NCT01111942] | Early Phase 1 | 4 participants (Actual) | Interventional | 2010-02-28 | Terminated(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 1 | 23 participants (Actual) | Interventional | 2010-04-27 | Terminated(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 3 | 221 participants (Actual) | Interventional | 2010-06-30 | Terminated(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 2 | 171 participants (Actual) | Interventional | 2010-10-31 | Completed |
Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients [NCT02199418] | Phase 2 | 132 participants (Actual) | Interventional | 2013-01-31 | Completed |
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 2 | 90 participants (Anticipated) | Interventional | 2022-10-27 | Recruiting |
A Phase I Study of TS-1, Cisplatin & RAD001 (Everolimus) [NCT01096199] | Phase 1 | 35 participants | Interventional | | Terminated |
Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients [NCT01096745] | Phase 2 | 78 participants (Anticipated) | Interventional | 2010-07-31 | Terminated(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 3 | 1,012 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy: a Patient Preference Multicenter Randomized Phase II Trial [NCT06084897] | Phase 2 | 120 participants (Anticipated) | Interventional | 2023-10-16 | Recruiting |
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 3 | 309 participants (Anticipated) | Interventional | 2023-11-20 | Not 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 3 | 295 participants (Actual) | Interventional | 2022-06-16 | Active, 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 2 | 30 participants (Actual) | Interventional | 2016-03-08 | Active, not recruiting |
Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study [NCT00968799] | | 6 participants (Actual) | Interventional | 2008-02-29 | Terminated(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 2 | 32 participants (Actual) | Interventional | 2009-05-22 | Completed |
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 2 | 165 participants (Actual) | Interventional | 2008-02-25 | Active, 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 3 | 225 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting |
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 3 | 990 participants (Anticipated) | Interventional | 2021-01-10 | Active, 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 3 | 452 participants (Actual) | Interventional | 2019-02-07 | Active, not recruiting |
A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Protocol [NCT03737994] | Phase 2 | 10 participants (Actual) | Interventional | 2019-07-25 | Active, not recruiting |
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) [NCT03533582] | Phase 2/Phase 3 | 537 participants (Anticipated) | Interventional | 2018-05-24 | Recruiting |
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 3 | 2,059 participants (Anticipated) | Interventional | 2017-05-25 | Recruiting |
A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients [NCT02724579] | Phase 2 | 45 participants (Anticipated) | Interventional | 2017-11-17 | Recruiting |
Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment [NCT00980460] | Phase 3 | 236 participants (Actual) | Interventional | 2009-09-14 | Active, 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 3 | 1,501 participants (Actual) | Interventional | 2007-06-01 | Active, not recruiting |
PEI REGIMEN: A THERAPEUTIC OPTION IN SMALL CELL LUNG CANCER? A MONOINSTITUTIONAL EXPERIENCE OF 46 CONSECUTIVE CASES [NCT02324296] | | 46 participants (Actual) | Observational | 1998-12-31 | Completed |
Cisplatin and Sodium Thiosulfate Otoprotection With or Without SAHA/Vorinostat Histone Deacetylase Inhibition for Relapsed/Refractory Hepatoblastoma and Other Embryonal Tumors [NCT05756660] | Early Phase 1 | 33 participants (Anticipated) | Interventional | 2023-03-01 | Recruiting |
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 2 | 22 participants (Actual) | Interventional | 2018-06-06 | Completed |
Clinical Study of Disulfiram Combined With Cisplatin in the Treatment of Advanced Gastric Cancer [NCT05667415] | | 40 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients [NCT01100801] | Phase 2 | 90 participants (Anticipated) | Interventional | 2010-07-31 | Recruiting |
A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites [NCT01327235] | Phase 2 | 336 participants (Actual) | Interventional | 2011-03-31 | Completed |
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 3 | 1,734 participants (Actual) | Interventional | 2002-09-30 | Completed |
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 2 | 94 participants (Actual) | Interventional | 2010-08-31 | Completed |
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 1 | 29 participants (Actual) | Interventional | 1999-11-30 | Completed |
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer [NCT01874678] | | 45 participants (Actual) | Interventional | 2011-03-31 | Completed |
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 3 | 724 participants (Anticipated) | Interventional | 2018-05-14 | Active, not recruiting |
Cytoreductive Surgery Plus Hyperthermic Intraoperative Peritoneal Chemotherapy With Cisplatin to Treat Peritoneal Carcinomatosis From Upper Gastrointestinal Cancer; the HIPCUpp-trial [NCT01116791] | Phase 2 | 34 participants (Actual) | Interventional | 2010-07-31 | Terminated(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 2 | 102 participants (Anticipated) | Interventional | 2016-12-12 | Recruiting |
Perioperative Versus Preoperative Chemotherapy With Surgery in Patients With Locoregional Squamous Carcinoma of Esophagus [NCT01225523] | Phase 1 | 350 participants (Actual) | Interventional | 1997-01-31 | Completed |
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 2 | 62 participants (Anticipated) | Interventional | 2018-12-06 | Recruiting |
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 2 | 80 participants (Actual) | Interventional | 2011-09-02 | Completed |
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 3 | 432 participants (Anticipated) | Interventional | 2018-03-01 | Recruiting |
Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01245959] | Phase 3 | 476 participants (Anticipated) | Interventional | 2011-01-31 | Active, 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 2 | 105 participants (Actual) | Interventional | 2011-01-31 | Terminated |
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 2 | 40 participants (Actual) | Interventional | 2012-12-19 | Active, not recruiting |
Phase I Trial of MK-3475 and Concurrent Chemo/Radiation for the Elimination of Small Cell Lung Cancer [NCT02402920] | Phase 1 | 83 participants (Actual) | Interventional | 2015-07-22 | Active, 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 2 | 124 participants (Actual) | Interventional | 2015-12-03 | Completed |
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 1 | 35 participants (Actual) | Interventional | 2010-06-30 | Completed |
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 2 | 43 participants (Anticipated) | Interventional | 2020-11-17 | Recruiting |
A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer [NCT01282151] | Phase 3 | 148 participants (Actual) | Interventional | 2011-07-31 | Terminated(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 2 | 110 participants (Anticipated) | Interventional | 2009-11-30 | Recruiting |
Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer [NCT01284413] | Phase 1/Phase 2 | 68 participants (Actual) | Interventional | 2010-12-31 | Completed |
"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 1 | 9 participants (Actual) | Interventional | 2010-08-31 | Terminated |
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 2 | 101 participants (Actual) | Interventional | 2010-01-31 | Completed |
A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer [NCT02501278] | Phase 2 | 0 participants (Actual) | Interventional | 2016-05-31 | Withdrawn(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 2 | 30 participants (Anticipated) | Interventional | 2022-12-01 | Recruiting |
PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer [NCT04481204] | Phase 2 | 105 participants (Actual) | Interventional | 2023-04-18 | Active, 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 1 | 0 participants (Actual) | Interventional | | Withdrawn(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 2 | 0 participants (Actual) | Interventional | 2021-09-09 | Withdrawn(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 1 | 29 participants (Actual) | Interventional | 2018-07-16 | Active, 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 3 | 437 participants (Actual) | Interventional | 2016-05-10 | Active, 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 2 | 236 participants (Anticipated) | Interventional | 2016-08-31 | Recruiting |
Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer. [NCT00915850] | Phase 1/Phase 2 | 32 participants (Anticipated) | Interventional | 2007-08-31 | Recruiting |
CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors [NCT01014767] | Phase 3 | 27 participants (Actual) | Interventional | 2009-11-30 | Terminated(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 1 | 9 participants (Actual) | Interventional | 2015-09-30 | Completed |
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 3 | 249 participants (Anticipated) | Interventional | 2021-11-12 | Recruiting |
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 2 | 74 participants (Actual) | Interventional | 2015-02-02 | Active, not recruiting |
Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma [NCT00742924] | Phase 1 | 24 participants (Actual) | Interventional | 2008-08-31 | Completed |
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 2 | 34 participants (Actual) | Interventional | 2009-11-06 | Completed |
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 2 | 73 participants (Actual) | Interventional | 2012-07-31 | Completed |
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial) [NCT05419089] | Phase 2 | 199 participants (Anticipated) | Interventional | 2022-07-12 | Recruiting |
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 3 | 177 participants (Actual) | Interventional | 2006-11-30 | Active, 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 3 | 362 participants (Anticipated) | Interventional | 2013-08-31 | Recruiting |
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 2 | 70 participants (Anticipated) | Interventional | 2008-12-31 | Recruiting |
A Phase I Study of the PI3-Kinase Inhibitor BKM120 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors [NCT01971489] | Phase 1 | 0 participants (Actual) | Interventional | 2015-09-30 | Withdrawn |
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 2 | 9 participants (Actual) | Interventional | 2010-04-30 | Terminated(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 1 | 28 participants (Actual) | Interventional | 2016-12-01 | Terminated(stopped due to Funding) |
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients. [NCT00659269] | Phase 3 | 319 participants (Actual) | Interventional | 2006-07-31 | Completed |
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 3 | 278 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
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 1 | 43 participants (Anticipated) | Interventional | 2019-11-08 | Recruiting |
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 3 | 457 participants (Actual) | Interventional | 2019-07-22 | Active, not recruiting |
Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA) [NCT00304278] | Phase 2 | 21 participants (Actual) | Interventional | 2006-03-31 | Completed |
Role of Neoadjuvant Chemotherapy in the Conservative Management of Non-muscle Invasive Bladder Cancer (NMIBC) T1b [NCT04245618] | | 50 participants (Anticipated) | Observational | 2020-07-31 | Not 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 2 | 88 participants (Actual) | Interventional | 2008-02-29 | Terminated(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 2 | 45 participants (Actual) | Interventional | 2008-11-30 | Completed |
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 2 | 120 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
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 3 | 424 participants (Anticipated) | Interventional | 2023-08-31 | Not 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 3 | 360 participants (Anticipated) | Interventional | 2014-06-30 | Active, 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 2 | 69 participants (Actual) | Interventional | 2003-05-31 | Terminated(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 3 | 298 participants (Anticipated) | Interventional | 2021-08-16 | Recruiting |
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 3 | 468 participants (Anticipated) | Interventional | 2019-04-03 | Active, 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 2 | 56 participants (Actual) | Interventional | 2018-08-08 | Completed |
An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors [NCT02937116] | Phase 1 | 233 participants (Actual) | Interventional | 2016-10-19 | Completed |
Exploratory Study of Molecular Phenotype Changes and Personalized Treatment for Patients With Castration Resistant Prostate Cancer [NCT02208583] | | 150 participants (Anticipated) | Interventional | 2014-06-30 | Recruiting |
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 3 | 249 participants (Actual) | Interventional | 2017-08-01 | Completed |
Immunochemotherapy: Do Platin-based Chemotherapeutics Enhance Dendritic Cell Vaccine Efficacy in Melanoma Patients? [NCT02285413] | Phase 2 | 54 participants (Actual) | Interventional | 2011-02-28 | Completed |
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients [NCT01755897] | | 337 participants (Actual) | Interventional | 2012-11-30 | Completed |
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 2 | 57 participants (Actual) | Interventional | 2012-07-02 | Active, not recruiting |
[NCT02513355] | Phase 4 | 400 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
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 3 | 326 participants (Anticipated) | Interventional | 2020-07-06 | Recruiting |
Phase II Study Comparing Gemcitabine Plus Cisplatin to Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma [NCT02016417] | Phase 2 | 120 participants (Anticipated) | Interventional | 2014-05-31 | Not 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 1 | 40 participants (Anticipated) | Interventional | 2024-01-09 | Not 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 3 | 111 participants (Actual) | Interventional | 2014-02-28 | Completed |
Phase II Study Comparing Intensity Modulated Radiotherapy (IMRT) in Combination With Concurrent Chemotherapy and IMRT Alone for Stage II Nasopharyngeal Carcinoma [NCT02116231] | Phase 2 | 80 participants (Anticipated) | Interventional | 2014-04-30 | Not yet recruiting |
Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer [NCT02128243] | Phase 2 | 242 participants (Actual) | Interventional | 2014-09-30 | Completed |
Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia [NCT03249519] | | 999 participants (Anticipated) | Interventional | 2017-08-01 | Recruiting |
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 3 | 716 participants (Anticipated) | Interventional | 2017-03-31 | Not yet recruiting |
Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC [NCT02064491] | Phase 2 | 18 participants (Actual) | Interventional | 2014-02-28 | Completed |
Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma: A Randomized Phase III Trial [NCT04898374] | Phase 3 | 120 participants (Anticipated) | Interventional | 2021-05-01 | Recruiting |
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 2 | 128 participants (Anticipated) | Interventional | 2017-04-07 | Recruiting |
[NCT02444949] | Phase 2 | 75 participants (Actual) | Interventional | 2014-06-30 | Completed |
Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial [NCT03194061] | | 20 participants (Actual) | Interventional | 2015-01-01 | Active, 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 2 | 90 participants (Anticipated) | Interventional | 2021-08-31 | Not 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 2 | 60 participants (Anticipated) | Interventional | 2015-05-31 | Not yet recruiting |
A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma [NCT06172296] | Phase 3 | 478 participants (Anticipated) | Interventional | 2024-02-14 | Not 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 3 | 504 participants (Anticipated) | Interventional | 2023-10-09 | Recruiting |
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 2 | 41 participants (Anticipated) | Interventional | 2022-03-09 | Recruiting |
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 2 | 11 participants (Actual) | Interventional | 2018-01-31 | Completed |
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 1 | 38 participants (Anticipated) | Interventional | 2015-01-08 | Completed |
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 2 | 96 participants (Anticipated) | Interventional | 2022-09-30 | Not 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 2 | 19 participants (Actual) | Interventional | 2015-04-30 | Completed |
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 1 | 0 participants (Actual) | Interventional | 2023-12-31 | Withdrawn(stopped due to Funding) |
IMMUNOCERV: Evaluating the Safety of Chemoradiation Combined With PDS0101 Immunotherapy in Treating Locally Advanced Cervical Cancer [NCT04580771] | Phase 2 | 35 participants (Anticipated) | Interventional | 2020-10-14 | Recruiting |
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 1 | 2 participants (Actual) | Interventional | 2015-09-21 | Active, 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 3 | 685 participants (Actual) | Interventional | 2014-04-21 | Active, not recruiting |
Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant [NCT00082706] | Phase 2 | 46 participants (Actual) | Interventional | 2003-04-23 | Active, 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 1 | 18 participants (Anticipated) | Interventional | 2020-08-07 | Recruiting |
Immuno-Chemotherapy as Single Treatment Modality for Larynx Preservation (ICoLP) [NCT04030455] | Phase 2 | 25 participants (Anticipated) | Interventional | 2019-08-07 | Recruiting |
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 2 | 80 participants (Anticipated) | Interventional | 2022-10-01 | Not yet recruiting |
DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy [NCT05541016] | Phase 2 | 320 participants (Anticipated) | Interventional | 2023-02-21 | Recruiting |
CASPIAN-RT Trial: Hypofractionated Consolidative Radiation Therapy After Durvalumab (MEDI4736) Plus Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer [NCT05161533] | Phase 2 | 0 participants (Actual) | Interventional | 2023-10-19 | Withdrawn(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 2 | 3 participants (Actual) | Interventional | 2017-09-01 | Completed |
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 2 | 123 participants (Actual) | Interventional | 2010-02-05 | Completed |
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 1 | 12 participants (Anticipated) | Interventional | 2010-03-31 | Completed |
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma [NCT02281955] | Phase 2 | 115 participants (Actual) | Interventional | 2014-08-31 | Active, 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 2 | 20 participants (Actual) | Interventional | 2006-01-31 | Completed |
The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma [NCT06138028] | Phase 2/Phase 3 | 90 participants (Anticipated) | Interventional | 2023-09-20 | Recruiting |
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 2 | 22 participants (Anticipated) | Interventional | 2023-11-16 | Recruiting |
A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma [NCT05823311] | Phase 3 | 80 participants (Anticipated) | Interventional | 2023-10-31 | Recruiting |
Neoadjuvant Chemotherapy Plus Cystectomy vs Cystectomy Alone for cT0 Muscle-invasive Bladder Cancer After Maximal TURBt: Multicentre Prospective Randomized Controlled Trial [NCT05776758] | Phase 3 | 236 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
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 2 | 30 participants (Anticipated) | Interventional | 2023-12-31 | Recruiting |
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 2 | 100 participants (Anticipated) | Interventional | 2022-01-31 | Recruiting |
Phase II Study of Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer [NCT05521997] | Phase 2 | 42 participants (Anticipated) | Interventional | 2024-01-31 | Not 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 1 | 45 participants (Anticipated) | Interventional | 2022-06-13 | Recruiting |
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 3 | 124 participants (Actual) | Interventional | 2011-04-30 | Completed |
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 2 | 158 participants (Actual) | Interventional | 2007-03-31 | Completed |
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 2 | 60 participants (Anticipated) | Interventional | 2009-04-30 | Recruiting |
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 2 | 46 participants (Actual) | Interventional | 2016-10-31 | Completed |
Atezolizumab With Platinum and Etoposide Chemotherapy Followed by Cystectomy for Patients With Localized Small Cell Neuroendocrine Bladder Cancer [NCT05312671] | Phase 2 | 63 participants (Anticipated) | Interventional | 2022-06-27 | Recruiting |
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 2 | 114 participants (Anticipated) | Interventional | 2007-08-31 | Recruiting |
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 2 | 31 participants (Actual) | Interventional | 2007-12-31 | Terminated(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 2 | 112 participants (Anticipated) | Interventional | 2019-06-01 | Not yet recruiting |
Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer [NCT00976976] | Phase 2 | 46 participants (Actual) | Interventional | 2007-05-31 | Completed |
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 3 | 104 participants (Actual) | Interventional | 2008-06-30 | Completed |
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 2 | 10 participants (Actual) | Interventional | 2018-06-19 | Completed |
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 2 | 46 participants (Actual) | Interventional | 2006-12-13 | Completed |
A Phase II Study of Sorafenib With Gemcitabine/Cisplatin in Advanced Hepatocellular Carcinoma [NCT00808145] | Phase 2 | 0 participants (Actual) | Interventional | 2009-02-28 | Withdrawn(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) | Interventional | 2008-12-31 | Completed |
Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer [NCT00381706] | Phase 2 | 245 participants (Actual) | Interventional | 2006-09-15 | Completed |
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 2 | 113 participants (Actual) | Interventional | 2007-01-01 | Completed |
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 2 | 5 participants (Actual) | Interventional | 2005-07-31 | Completed |
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 3 | 640 participants (Actual) | Interventional | 2020-10-19 | Active, 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 2 | 158 participants (Anticipated) | Interventional | 2021-09-03 | Recruiting |
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 1 | 102 participants (Actual) | Interventional | 2005-12-31 | Completed |
A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer [NCT00003298] | Phase 2 | 39 participants (Actual) | Interventional | 1999-06-01 | Completed |
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 1 | 40 participants (Anticipated) | Interventional | 2014-05-19 | Active, 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 2 | 80 participants (Actual) | Interventional | 2001-05-31 | Completed |
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) | Interventional | 2007-02-28 | Completed |
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 2 | 12 participants (Actual) | Interventional | 2021-08-25 | Terminated(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 2 | 60 participants (Anticipated) | Interventional | 2016-05-31 | Not 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 3 | 241 participants (Actual) | Interventional | 2001-04-30 | Completed |
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 3 | 300 participants (Anticipated) | Interventional | 2013-07-31 | Recruiting |
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 2 | 16 participants (Actual) | Interventional | 2020-10-14 | Completed |
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 3 | 254 participants (Anticipated) | Interventional | 2016-03-31 | Completed |
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 2 | 67 participants (Actual) | Interventional | 2016-04-15 | Completed |
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 2 | 44 participants (Anticipated) | Interventional | 2019-05-01 | Recruiting |
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 2 | 41 participants (Actual) | Interventional | 2008-02-29 | Terminated(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) | Interventional | 2013-10-31 | Completed |
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 2 | 60 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting |
Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer [NCT00657423] | Phase 3 | 80 participants (Anticipated) | Interventional | 2008-04-30 | Recruiting |
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 3 | 352 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion [NCT02657460] | Phase 2 | 90 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
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 2 | 30 participants (Anticipated) | Interventional | 2020-11-30 | Not 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 3 | 476 participants (Anticipated) | Interventional | 2024-01-01 | Not 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 2 | 124 participants (Anticipated) | Interventional | 2023-10-31 | Recruiting |
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 2 | 60 participants (Anticipated) | Interventional | 2018-08-14 | Recruiting |
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 2 | 11 participants (Actual) | Interventional | 2009-04-30 | Terminated(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 2 | 168 participants (Actual) | Interventional | 2009-07-16 | Completed |
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 2 | 289 participants (Actual) | Interventional | 2009-02-28 | Completed |
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 1 | 14 participants (Actual) | Interventional | 2009-08-31 | Completed |
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 3 | 338 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
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 2 | 116 participants (Anticipated) | Interventional | 2008-03-31 | Recruiting |
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 2 | 21 participants (Anticipated) | Interventional | 2019-12-01 | Not yet recruiting |
A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors [NCT00072332] | Phase 1 | 0 participants | Interventional | 2003-08-31 | Completed |
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 2 | 221 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT00677118] | Phase 3 | 506 participants (Anticipated) | Interventional | 2006-06-30 | Active, 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 3 | 201 participants (Actual) | Interventional | 2005-04-30 | Completed |
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 4 | 6 participants (Actual) | Interventional | 2008-04-30 | Completed |
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 3 | 740 participants (Actual) | Interventional | 2008-07-31 | Completed |
Clinical Application of Efficacy Prediction Model Based on Epigenomics Sequencing Technology in Neoadjuvant Immunotherapy for Esophageal Cancer [NCT05880082] | Phase 2 | 62 participants (Anticipated) | Interventional | 2023-05-31 | Not 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) | Observational | 2023-05-16 | Not 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 1 | 144 participants (Anticipated) | Interventional | 2022-09-20 | Recruiting |
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 3 | 1,538 participants (Anticipated) | Interventional | 2018-05-18 | Active, 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 2 | 49 participants (Actual) | Interventional | 2005-12-31 | Completed |
Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer [NCT03998696] | Phase 4 | 60 participants (Actual) | Interventional | 2017-07-01 | Completed |
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 2 | 137 participants (Actual) | Interventional | 2008-01-31 | Terminated(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 2 | 20 participants (Anticipated) | Interventional | 2007-02-28 | Terminated(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 3 | 1,069 participants (Actual) | Interventional | 2019-09-24 | Active, not recruiting |
A Phase III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPSCC [NCT03811015] | Phase 3 | 636 participants (Anticipated) | Interventional | 2019-08-16 | Recruiting |
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 2 | 72 participants (Anticipated) | Interventional | 2023-10-30 | Recruiting |
Toripalimab in Combination With Cetuximab,Cisplatin and 5-FU for Conversion Therapy of Locally Nonresectable Oral Cavity Squamous Cell Carcinoma (OCSCC) [NCT06081582] | Phase 2 | 33 participants (Anticipated) | Interventional | 2023-07-06 | Recruiting |
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 1 | 50 participants (Actual) | Interventional | 2005-10-05 | Active, not recruiting |
A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer [NCT02254278] | Phase 2 | 316 participants (Actual) | Interventional | 2014-10-31 | Active, 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 2 | 30 participants (Actual) | Interventional | 1999-08-31 | Completed |
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 3 | 235 participants (Actual) | Interventional | 2009-10-28 | Completed |
Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer [NCT04017377] | | 15 participants (Anticipated) | Interventional | 2019-09-01 | Recruiting |
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 1 | 8 participants (Actual) | Interventional | 2019-04-30 | Completed |
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 2 | 101 participants (Actual) | Interventional | 2007-05-31 | Terminated(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 3 | 1,053 participants (Actual) | Interventional | 2005-05-31 | Completed |
Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients [NCT00950261] | Phase 2 | 0 participants (Actual) | Interventional | 2009-01-31 | Withdrawn(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 2 | 181 participants (Actual) | Interventional | 2007-06-30 | Completed |
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 2 | 60 participants (Actual) | Interventional | 2009-08-31 | Completed |
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 2 | 152 participants (Actual) | Interventional | 2007-11-30 | Completed |
A Phase I Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology [NCT03330028] | Phase 1 | 29 participants (Actual) | Interventional | 2017-10-27 | Completed |
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 1 | 431 participants (Actual) | Interventional | 2009-10-28 | Completed |
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 2 | 14 participants (Actual) | Interventional | 2010-08-31 | Completed |
[NCT02142010] | | 67 participants (Anticipated) | Interventional | 2014-08-31 | Recruiting |
Toripalimab With Paclitaxel and Cisplatin as Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma [NCT04804696] | Phase 2 | 53 participants (Anticipated) | Interventional | 2021-02-10 | Recruiting |
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 3 | 1,186 participants (Actual) | Interventional | 2017-06-01 | Active, 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) | Interventional | 2001-10-31 | Completed |
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 3 | 534 participants (Anticipated) | Interventional | 2016-01-31 | Not 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 3 | 707 participants (Actual) | Interventional | 2004-02-29 | Completed |
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 2 | 78 participants (Anticipated) | Interventional | 2022-12-15 | Recruiting |
A Phase I Adaptive Design Trial of Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors [NCT02537561] | Phase 1 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn(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 2 | 52 participants (Anticipated) | Interventional | 2023-01-25 | Recruiting |
A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients [NCT00916500] | Phase 2 | 71 participants (Actual) | Interventional | 2006-03-31 | Completed |
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 2 | 304 participants (Anticipated) | Interventional | 2011-07-31 | Recruiting |
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 1 | 21 participants (Actual) | Interventional | 2016-01-31 | Completed |
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) | Interventional | 2015-12-31 | Active, 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 2 | 232 participants (Actual) | Interventional | 2009-02-28 | Completed |
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 1 | 48 participants (Actual) | Interventional | 2006-12-31 | Completed |
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 2 | 92 participants (Actual) | Interventional | 2002-07-31 | Completed |
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 1 | 15 participants (Anticipated) | Interventional | 2019-03-12 | Recruiting |
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 2 | 30 participants (Actual) | Interventional | 2008-12-19 | Completed |
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009) [NCT02624531] | | 60 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
An Individualized Cancer Vaccine for Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT02624999] | Phase 2 | 0 participants (Actual) | Interventional | 2016-12-31 | Withdrawn(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 1 | 12 participants (Actual) | Interventional | 2015-10-26 | Completed |
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 2 | 27 participants (Actual) | Interventional | 2009-06-30 | Completed |
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 3 | 648 participants (Actual) | Interventional | 2009-10-31 | Terminated(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 3 | 504 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer [NCT02607540] | Phase 3 | 210 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer [NCT02595554] | Phase 3 | 220 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
A Phase 1/2 Study of the Bromodomain Inhibitor Molibresib in Combination With Etoposide/Platinum in Patients With NUT Carcinoma [NCT04116359] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2020-09-18 | Withdrawn(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 2 | 47 participants (Actual) | Interventional | 2019-10-07 | Active, 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 2 | 30 participants (Anticipated) | Interventional | 2019-09-24 | Recruiting |
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 2 | 94 participants (Actual) | Interventional | 2012-08-31 | Active, 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) | Interventional | 2009-07-31 | Withdrawn(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 2 | 80 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT) [NCT00785421] | Phase 2/Phase 3 | 312 participants (Actual) | Interventional | 2004-04-30 | Completed |
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 3 | 268 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma:: A Phase 3 Trial [NCT03919552] | Phase 3 | 482 participants (Anticipated) | Interventional | 2018-01-31 | Recruiting |
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 2 | 26 participants (Actual) | Interventional | 2009-09-30 | Completed |
Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine [NCT02648425] | Phase 1 | 31 participants (Actual) | Interventional | 2014-08-05 | Completed |
Phase Ib Trial of Pembrolizumab (MK-3475) With Platinum-Based Chemotherapy in Small Cell/Neuroendocrine Cancers of Urothelium and Prostate [NCT03582475] | Phase 1 | 15 participants (Actual) | Interventional | 2018-12-20 | Completed |
A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma [NCT00554788] | Phase 3 | 60 participants (Actual) | Interventional | 2008-02-04 | Active, 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 3 | 89 participants (Actual) | Interventional | 2017-01-31 | Completed |
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 2 | 49 participants (Anticipated) | Interventional | 2009-02-28 | Not 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 3 | 540 participants (Actual) | Interventional | 2019-12-19 | Completed |
Intraoperative Intraperitoneal Chemoperfusion to Treat Peritoneal Minimal Residual Disease in Stage III Ovarian Cancer: A Randomized Phase II Trial [NCT02567253] | Phase 2 | 56 participants (Actual) | Interventional | 2016-03-31 | Completed |
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 1 | 22 participants (Actual) | Interventional | 2009-07-31 | Terminated(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 2 | 41 participants (Actual) | Interventional | 2002-02-28 | Completed |
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 3 | 686 participants (Anticipated) | Interventional | 2002-03-31 | Active, 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 3 | 125 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Slow recruitment) |
[NCT02795884] | Phase 3 | 0 participants (Actual) | Interventional | 2016-06-30 | Withdrawn(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 2 | 48 participants (Actual) | Interventional | 2010-06-30 | Completed |
Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan [NCT02777788] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2014-09-30 | Active, 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 3 | 0 participants (Actual) | Interventional | 2010-07-31 | Withdrawn |
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 3 | 813 participants (Actual) | Interventional | 2009-06-29 | Active, 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 1 | 36 participants (Anticipated) | Interventional | 2020-11-11 | Recruiting |
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 1 | 103 participants (Actual) | Interventional | 2010-03-31 | Completed |
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 2 | 82 participants (Actual) | Interventional | 2003-02-28 | Completed |
Phase 1 Study of Ixabepilone in Combination With Cisplatin in Subjects With Advanced Solid Tumors [NCT00832117] | Phase 1 | 30 participants (Actual) | Interventional | 2009-05-31 | Completed |
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 2 | 6 participants (Actual) | Interventional | 2016-01-16 | Completed |
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 1 | 0 participants (Actual) | Interventional | 2009-07-31 | Withdrawn(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 2 | 140 participants (Anticipated) | Interventional | 2016-09-30 | Not yet recruiting |
Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck [NCT00868491] | Phase 2 | 30 participants (Anticipated) | Interventional | 2008-03-31 | Completed |
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 3 | 609 participants (Actual) | Interventional | 2012-10-31 | Terminated(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 2 | 42 participants (Actual) | Interventional | 2019-01-14 | Active, 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 1 | 12 participants (Actual) | Interventional | 2011-11-30 | Completed |
Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC) [NCT04329494] | Phase 1 | 49 participants (Anticipated) | Interventional | 2020-08-21 | Recruiting |
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) | Interventional | 2011-03-31 | Recruiting |
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 3 | 2 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
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 3 | 980 participants (Anticipated) | Interventional | 2020-05-12 | Active, 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 2 | 90 participants (Actual) | Interventional | 2021-01-20 | Completed |
IPI-Biochemotherapy for Chemonaive Patients With Metastatic Melanoma [NCT01409174] | Phase 1 | 19 participants (Actual) | Interventional | 2013-02-28 | Terminated(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 2 | 80 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting |
Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer [NCT04311762] | Phase 1 | 9 participants (Anticipated) | Interventional | 2020-02-26 | Recruiting |
Phase II Study Evaluating Combination Chemotherapy + Radiotherapy (RT) With Avelumab in Muscle Invasive Bladder Cancer [NCT03617913] | Phase 2 | 2 participants (Actual) | Interventional | 2018-09-19 | Completed |
Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma [NCT00970996] | Phase 1 | 10 participants (Actual) | Interventional | 2009-09-30 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2009-07-31 | Withdrawn |
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 3 | 485 participants (Actual) | Interventional | 2002-06-30 | Completed |
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 2 | 86 participants (Anticipated) | Interventional | 2018-06-21 | Recruiting |
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 2 | 4 participants (Actual) | Interventional | 2020-10-14 | Active, not recruiting |
Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma [NCT00567567] | Phase 3 | 665 participants (Actual) | Interventional | 2007-11-05 | Completed |
Chemoembolization for Hepatocellular Carcinoma [NCT02821533] | Phase 2 | 24 participants (Actual) | Interventional | 2012-02-29 | Terminated(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 2 | 50 participants (Anticipated) | Interventional | 2016-06-30 | Recruiting |
A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation [NCT05800574] | Phase 2 | 22 participants (Anticipated) | Interventional | 2023-03-14 | Recruiting |
Phase I/II Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma [NCT02801487] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2015-09-30 | Terminated(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 2 | 0 participants (Actual) | Interventional | 2016-07-31 | Withdrawn(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 3 | 198 participants (Anticipated) | Interventional | 2014-03-31 | Recruiting |
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 2 | 130 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
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 1 | 23 participants (Actual) | Interventional | 2009-02-28 | Completed |
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 1 | 1 participants (Actual) | Interventional | 2012-06-30 | Terminated(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 3 | 360 participants (Anticipated) | Interventional | 2008-10-31 | Recruiting |
Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma: a Phase 3 Non-inferior Multicenter Randomized Controlled Trial [NCT02610010] | Phase 3 | 462 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin [NCT00999700] | Phase 3 | 282 participants (Anticipated) | Interventional | 2009-09-30 | Active, 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 3 | 158 participants (Actual) | Interventional | 2020-07-10 | Active, 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 1 | 26 participants (Actual) | Interventional | 2015-04-03 | Active, not recruiting |
PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study [NCT04115410] | | 4,724 participants (Anticipated) | Observational | 2020-07-01 | Not 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 2 | 105 participants (Actual) | Interventional | 2015-10-31 | Completed |
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 3 | 448 participants (Actual) | Interventional | 2008-02-29 | Completed |
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 2 | 186 participants (Anticipated) | Interventional | 2020-02-06 | Not yet recruiting |
Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer [NCT05313906] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-05-07 | Not 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 1 | 15 participants (Actual) | Interventional | 2013-02-28 | Completed |
Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC [NCT01993810] | Phase 3 | 330 participants (Actual) | Interventional | 2014-02-03 | Active, 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 2 | 94 participants (Actual) | Interventional | 2009-08-31 | Completed |
Role of Early 18F-FDG-PET/CT Scan in Predicting Mediastinal Downstaging With Neoadjuvant Chemotherapy in Resectable Stage III A NSCLC [NCT02607423] | Phase 2 | 0 participants (Actual) | Interventional | 2015-11-19 | Withdrawn(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 2 | 157 participants (Anticipated) | Interventional | 2021-01-01 | Recruiting |
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 3 | 20 participants (Actual) | Interventional | 2006-07-31 | Terminated(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 3 | 0 participants | Interventional | 2000-08-31 | Completed |
A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes [NCT00006096] | Phase 3 | 0 participants | Interventional | 2001-03-31 | Terminated |
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 3 | 572 participants (Anticipated) | Interventional | 2022-02-26 | Recruiting |
A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma [NCT00262951] | Phase 2 | 23 participants (Actual) | Interventional | 2005-01-31 | Terminated(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 1 | 50 participants | Interventional | 1992-12-31 | Completed |
Phase I Study of TTC (Taxotere/Temodar/Cisplatin) in Metastatic Melanoma Patients [NCT00527761] | Phase 1 | 23 participants (Actual) | Interventional | 2004-08-31 | Completed |
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) | Interventional | 2016-11-30 | Withdrawn |
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer [NCT00123318] | Phase 3 | 52 participants (Actual) | Interventional | 2003-02-28 | Completed |
A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer [NCT00148694] | Phase 2 | 27 participants (Actual) | Interventional | 2004-07-31 | Completed |
A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma [NCT00818090] | Phase 2 | 39 participants (Actual) | Interventional | 2008-09-30 | Terminated(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 2 | 17 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
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 2 | 58 participants (Anticipated) | Interventional | 2003-08-31 | Completed |
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 3 | 310 participants (Anticipated) | Interventional | 2005-09-27 | Completed |
A Phase II Trial of Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma [NCT04006041] | Phase 2 | 44 participants (Anticipated) | Interventional | 2019-06-25 | Recruiting |
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 3 | 700 participants (Actual) | Interventional | 2002-08-31 | Completed |
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 2 | 60 participants (Anticipated) | Interventional | 2019-07-05 | Not 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 2 | 34 participants (Actual) | Interventional | 2008-11-30 | Terminated(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 3 | 330 participants | Interventional | 2000-05-31 | Terminated |
Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma [NCT01000415] | Phase 3 | 824 participants (Anticipated) | Interventional | 2009-06-30 | Recruiting |
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) | Observational | 2009-10-15 | Completed |
A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer [NCT00388154] | Phase 2 | 21 participants (Actual) | Interventional | 2004-08-31 | Completed |
A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA [NCT00369122] | Phase 2 | 60 participants (Actual) | Interventional | 2006-08-11 | Completed |
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 2 | 135 participants (Actual) | Interventional | 2010-02-28 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2023-11-30 | Withdrawn(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 2 | 20 participants (Anticipated) | Interventional | 2023-01-30 | Recruiting |
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 2 | 19 participants (Actual) | Interventional | 2005-04-30 | Terminated(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 2 | 106 participants (Actual) | Interventional | 2006-03-31 | Completed |
A Phase I Trial Using RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer [NCT01058408] | Phase 1 | 3 participants (Actual) | Interventional | 2010-02-28 | Terminated |
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) | Interventional | 2019-09-01 | Recruiting |
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 1 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn(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 3 | 375 participants (Actual) | Interventional | 2008-09-30 | Completed |
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 3 | 320 participants (Actual) | Interventional | 2008-03-31 | Completed |
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 2 | 55 participants (Actual) | Interventional | 2003-06-30 | Completed |
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 1 | 59 participants (Actual) | Interventional | 2015-11-30 | Active, not recruiting |
Immunotherapy With MK-3475 in Locoregionally Advanced, Surgically Resectable Head and Neck Squamous Cell Carcinoma [NCT02296684] | Phase 2 | 67 participants (Actual) | Interventional | 2015-03-25 | Active, not recruiting |
Pilot Trial of Sirolimus, Gemcitabine and Cisplatin for Patients With High Risk for Cholangiocarcinoma Recurrence [NCT01888302] | Phase 1 | 1 participants (Actual) | Interventional | 2013-09-30 | Completed |
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 1 | 24 participants (Actual) | Interventional | 2013-05-31 | Completed |
Preconditioning Chemotherapy Combined With Cytokine Induced Killer Cell Immunotherapy in Advanced Non Small Cell Lung Cancer [NCT01902875] | | 100 participants (Anticipated) | Observational | 2013-06-30 | Recruiting |
The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer [NCT01917617] | Phase 2 | 50 participants (Actual) | Interventional | 2013-05-22 | Completed |
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 2 | 80 participants (Anticipated) | Interventional | 2008-01-31 | Completed |
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 3 | 360 participants (Anticipated) | Interventional | 2004-07-31 | Recruiting |
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 2 | 30 participants (Anticipated) | Interventional | 2003-10-31 | Completed |
Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma [NCT01947062] | Phase 3 | 60 participants (Anticipated) | Interventional | 2013-10-31 | Not 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 2 | 108 participants (Anticipated) | Interventional | 2013-06-30 | Recruiting |
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 2 | 0 participants (Actual) | Interventional | 2013-12-31 | Withdrawn(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 3 | 240 participants (Anticipated) | Interventional | 2018-08-20 | Recruiting |
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Advanced Solid Tumors [NCT01980667] | Phase 1 | 41 participants (Actual) | Interventional | 2014-07-30 | Completed |
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 4 | 250 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer [NCT01993979] | Phase 3 | 261 participants (Actual) | Interventional | 2012-05-31 | Active, 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 2 | 58 participants (Anticipated) | Interventional | 2020-10-31 | Recruiting |
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) | Interventional | 2016-01-01 | Active, not recruiting |
Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer [NCT01999933] | Phase 2/Phase 3 | 600 participants (Anticipated) | Interventional | 2013-11-30 | Recruiting |
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 3 | 392 participants (Anticipated) | Interventional | 2013-10-31 | Active, 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 1 | 35 participants (Anticipated) | Interventional | 2023-12-23 | Not 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 2 | 150 participants (Anticipated) | Interventional | 2019-12-08 | Active, 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 2 | 250 participants (Anticipated) | Interventional | 2022-05-05 | Recruiting |
A Single-Arm Phase 2 Study to Investigate Bintrafusp Alfa With Platinum-Pemetrexed for TKI-Resistant EGFR-Mutant NSCLC [NCT04971187] | Phase 2 | 3 participants (Actual) | Interventional | 2021-06-30 | Terminated(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 3 | 415 participants (Actual) | Interventional | 2015-10-20 | Active, 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 2 | 70 participants (Anticipated) | Interventional | 2013-12-31 | Recruiting |
A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients With High Grade Upper Tract Urothelial Carcinoma [NCT02412670] | Phase 2 | 36 participants (Actual) | Interventional | 2015-08-27 | Completed |
Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer [NCT00008112] | Phase 2 | 0 participants | Interventional | 2000-06-30 | Active, 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 2 | 23 participants (Anticipated) | Interventional | 2020-11-26 | Recruiting |
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 2 | 252 participants (Actual) | Interventional | 2011-01-31 | Active, 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 2 | 188 participants (Anticipated) | Interventional | 2021-04-27 | Recruiting |
Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO) [NCT04267848] | Phase 3 | 1,210 participants (Anticipated) | Interventional | 2020-06-16 | Recruiting |
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) [NCT02194738] | | 8,300 participants (Anticipated) | Interventional | 2014-09-26 | Recruiting |
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 2 | 9 participants (Actual) | Interventional | 2009-10-31 | Terminated(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 2 | 0 participants (Actual) | Interventional | 2020-12-31 | Withdrawn(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 2 | 30 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
A Randomized Study of Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation Therapy in Stage III Unresectable NSCLC [NCT00191139] | Phase 2 | 64 participants (Actual) | Interventional | 2003-03-31 | Completed |
Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin [NCT02667925] | | 0 participants (Actual) | Interventional | 2016-03-31 | Withdrawn(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] | 2020-04-01 | Recruiting |
A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Study [NCT06048926] | | 30 participants (Anticipated) | Interventional | 2022-07-30 | Enrolling 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 2 | 20 participants (Anticipated) | Interventional | 2023-03-16 | Recruiting |
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 3 | 474 participants (Anticipated) | Interventional | 2023-05-10 | Recruiting |
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 2 | 490 participants (Anticipated) | Interventional | 2022-09-01 | Recruiting |
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 2 | 27 participants (Anticipated) | Interventional | 2022-03-30 | Recruiting |
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 3 | 464 participants (Anticipated) | Interventional | 2021-10-27 | Recruiting |
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 3 | 328 participants (Actual) | Interventional | 2018-03-29 | Active, not recruiting |
Phase III Randomized Trial of Immunotherapy With or Without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma [NCT05721755] | Phase 3 | 290 participants (Anticipated) | Interventional | 2023-06-08 | Recruiting |
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 1 | 21 participants (Actual) | Interventional | 2020-12-07 | Completed |
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 3 | 947 participants (Actual) | Interventional | 2016-10-05 | Completed |
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 2 | 31 participants (Actual) | Interventional | 2008-06-16 | Active, 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 2 | 35 participants (Actual) | Interventional | 2008-10-31 | Completed |
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) | Interventional | 2021-07-19 | Recruiting |
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 2 | 170 participants (Actual) | Interventional | 2012-05-31 | Terminated(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 2 | 48 participants (Actual) | Interventional | 2011-06-06 | Completed |
Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer [NCT02879227] | Phase 2 | 23 participants (Actual) | Interventional | 2010-01-31 | Completed |
A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus [NCT02586753] | Phase 2 | 2 participants (Anticipated) | Interventional | 2015-12-31 | Not yet recruiting |
Safety of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Biliary Tract Cancer Patients With Peritoneal Metastases [NCT05285358] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-09-19 | Recruiting |
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 3 | 519 participants (Actual) | Interventional | 2008-07-07 | Completed |
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 3 | 241 participants (Actual) | Interventional | 2016-10-20 | Completed |
A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer [NCT00717938] | Phase 3 | 390 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Phase II Trial of Xevinapant in Combination With Post-Operative Cisplatin and Radiotherapy for High Risk Head and Neck Cancer [NCT06145412] | Phase 2 | 54 participants (Anticipated) | Interventional | 2023-11-16 | Recruiting |
Phase II Study of Induction Checkpoint Blockade for Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection [NCT03158129] | Phase 2 | 101 participants (Actual) | Interventional | 2017-06-09 | Active, 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 3 | 120 participants (Actual) | Interventional | 2008-01-31 | Completed |
Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer. [NCT03649048] | | 100 participants (Anticipated) | Interventional | 2018-11-05 | Recruiting |
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 2 | 26 participants (Anticipated) | Interventional | 2018-10-27 | Recruiting |
a Prospective Random Study on the Efficacy and Safety of Bevacizumab in Untreated Patients With Locally Advanced Cervical Cancer [NCT04138992] | Phase 2/Phase 3 | 150 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
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 3 | 346 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
Phase â…¡ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma [NCT00817258] | Phase 2 | 37 participants (Anticipated) | Interventional | 2007-01-31 | Recruiting |
A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma [NCT00951496] | Phase 3 | 1,560 participants (Actual) | Interventional | 2009-08-11 | Completed |
Phase II Study of Cisplatinum and Everolimus in Patients With Metastatic or Unresectable Neuroendocrine Carcinomas (NEC) of Extrapulmonary Origin [NCT02695459] | Phase 2 | 39 participants (Actual) | Interventional | 2016-03-30 | Active, 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 3 | 598 participants (Anticipated) | Interventional | 2016-02-29 | Recruiting |
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 2 | 77 participants (Actual) | Interventional | 2008-01-31 | Completed |
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 2 | 25 participants (Actual) | Interventional | 2010-06-30 | Terminated(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) | Interventional | 2021-03-12 | Recruiting |
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 3 | 400 participants (Actual) | Interventional | 2008-02-29 | Terminated(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 2 | 78 participants (Anticipated) | Interventional | 2020-06-23 | Recruiting |
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 2 | 76 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
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 2 | 50 participants (Actual) | Interventional | 2010-05-04 | Terminated(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 3 | 540 participants (Actual) | Interventional | 2021-08-01 | Active, 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 3 | 596 participants (Actual) | Interventional | 2018-12-03 | Completed |
Chidamide Combined With Cisplatin for Relapsed or Metastatic Triple-negative Breast Cancer [NCT04192903] | Phase 2 | 55 participants (Anticipated) | Interventional | 2019-12-25 | Recruiting |
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) | Interventional | 2020-12-31 | Not 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 1 | 0 participants (Actual) | Interventional | 2017-05-01 | Withdrawn(stopped due to Site dropped study) |
Induction Chemotherapy of Docetaxel, Cisplatin and Xeloda in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma [NCT02786641] | Phase 3 | 235 participants (Anticipated) | Interventional | 2016-08-31 | Not yet recruiting |
Phase I Study of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion With Cisplatin in Patients With Recurrent Ovarian Cancer [NCT01387399] | Phase 1 | 9 participants (Anticipated) | Interventional | 2011-06-30 | Active, 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 3 | 72 participants (Actual) | Interventional | 2011-12-05 | Active, not recruiting |
[NCT01488838] | Phase 2 | 120 participants (Actual) | Interventional | 2011-11-30 | Completed |
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 3 | 926 participants (Actual) | Interventional | 2012-01-09 | Completed |
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 1 | 0 participants (Actual) | Interventional | 2011-08-31 | Withdrawn(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 2 | 80 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer [NCT01424709] | Phase 2 | 120 participants (Anticipated) | Interventional | 2010-12-31 | Active, 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 4 | 400 participants (Anticipated) | Interventional | 2011-10-31 | Recruiting |
Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma [NCT01425736] | Phase 2 | 91 participants (Actual) | Interventional | 2009-01-31 | Completed |
A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer [NCT04809103] | Phase 1 | 10 participants (Anticipated) | Interventional | 2021-03-08 | Recruiting |
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 2 | 218 participants (Anticipated) | Interventional | 2011-09-30 | Recruiting |
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 3 | 208 participants (Anticipated) | Interventional | 2009-02-28 | Enrolling 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) | Interventional | 2020-05-26 | Recruiting |
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 1 | 500 participants (Anticipated) | Interventional | 2008-01-31 | Recruiting |
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 3 | 528 participants (Anticipated) | Interventional | 2015-06-30 | Completed |
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 1 | 1 participants (Actual) | Interventional | 2015-09-30 | Terminated(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 3 | 155 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
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 2 | 15 participants (Actual) | Interventional | 2003-07-31 | Completed |
A Phase II Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer [NCT00798655] | Phase 2 | 46 participants (Actual) | Interventional | 2007-11-30 | Completed |
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 3 | 133 participants (Actual) | Interventional | 2010-06-30 | Completed |
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer [NCT00150670] | Phase 3 | 300 participants | Interventional | 2002-03-31 | Completed |
Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy [NCT02844114] | Phase 2 | 60 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
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 1 | 442 participants (Anticipated) | Interventional | 2018-07-11 | Active, 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 3 | 625 participants (Actual) | Interventional | 2009-01-31 | Completed |
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 3 | 100 participants (Anticipated) | Interventional | 2016-09-30 | Not 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 2 | 36 participants (Anticipated) | Interventional | 2003-09-30 | Recruiting |
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 3 | 1,122 participants (Anticipated) | Interventional | 2023-03-03 | Suspended(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 3 | 430 participants (Anticipated) | Interventional | 2023-03-13 | Recruiting |
Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab [NCT03811002] | Phase 3 | 545 participants (Anticipated) | Interventional | 2019-07-26 | Recruiting |
Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer [NCT03775265] | Phase 3 | 475 participants (Anticipated) | Interventional | 2019-06-03 | Recruiting |
A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers [NCT01825603] | Phase 1 | 17 participants (Actual) | Interventional | 2013-04-09 | Completed |
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 1 | 24 participants (Actual) | Interventional | 2006-03-31 | Completed |
Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy [NCT04920344] | Phase 2 | 15 participants (Actual) | Interventional | 2021-07-19 | Active, not recruiting |
Pembrolizumab and aMVAC Chemotherapy as Neoadjuvant Therapy in Non-Urothelial Histology Muscle-Invasive Bladder Cancer: A Pilot Trial [NCT04383743] | Phase 2 | 17 participants (Anticipated) | Interventional | 2020-11-24 | Recruiting |
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study [NCT01854749] | Phase 2 | 57 participants (Actual) | Interventional | 2011-11-30 | Completed |
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 2 | 80 participants (Anticipated) | Interventional | 2017-04-11 | Recruiting |
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 2 | 48 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01872962] | Phase 3 | 480 participants (Actual) | Interventional | 2013-11-30 | Active, 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 2 | 62 participants (Actual) | Interventional | 2019-07-25 | Active, 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 3 | 21 participants (Actual) | Interventional | 2006-07-31 | Terminated(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 2 | 63 participants (Actual) | Interventional | 2018-10-23 | Active, 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) | Interventional | 2022-05-02 | Recruiting |
Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis [NCT00004547] | Phase 2 | 188 participants (Actual) | Interventional | 2000-01-31 | Completed |
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 3 | 506 participants (Actual) | Interventional | 2009-07-15 | Completed |
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer [NCT01683864] | Phase 2/Phase 3 | 3 participants (Actual) | Interventional | 2012-09-30 | Terminated(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 3 | 470 participants (Anticipated) | Interventional | 1994-06-30 | Completed |
A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma [NCT00004188] | Phase 3 | 495 participants (Actual) | Interventional | 2001-02-28 | Completed |
A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract [NCT00353015] | Phase 2 | 21 participants (Actual) | Interventional | 2003-03-31 | Completed |
Phase II Study of Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer [NCT00995761] | Phase 2 | 48 participants (Actual) | Interventional | 2009-10-31 | Completed |
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 2 | 160 participants (Anticipated) | Interventional | 2020-10-08 | Not 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 2 | 27 participants (Actual) | Interventional | 2011-01-26 | Completed |
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 2 | 160 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
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 2 | 60 participants (Actual) | Interventional | 2007-09-30 | Completed |
p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial [NCT00525200] | Phase 3 | 170 participants (Actual) | Interventional | 2007-06-30 | Completed |
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 2 | 2 participants (Actual) | Interventional | 2016-03-31 | Terminated(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 2 | 88 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
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) | Interventional | 2007-06-30 | Completed |
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) | Interventional | 2009-07-31 | Completed |
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 3 | 760 participants (Actual) | Interventional | 2006-12-31 | Completed |
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 2 | 401 participants (Actual) | Interventional | 2018-12-21 | Active, not recruiting |
A Phase II Study of Olaparib Plus Cediranib in Combination With Standard Therapy for Small Cell Lung Cancer [NCT02899728] | Phase 2 | 9 participants (Actual) | Interventional | 2018-03-30 | Terminated(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 1 | 12 participants (Actual) | Interventional | 2002-05-31 | Completed |
A Phase II Trial of Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer [NCT04224740] | Phase 2 | 37 participants (Actual) | Interventional | 2020-06-15 | Active, 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 3 | 704 participants (Anticipated) | Interventional | 2018-12-17 | Active, not recruiting |
Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC [NCT04585490] | Phase 3 | 48 participants (Anticipated) | Interventional | 2021-08-25 | Recruiting |
Neoadjuvant Nivolumab Plus Paclitaxel/ Cisplatin- Chemo- Radiotherapy (Neo-NTP-CRT) Followed by Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) [NCT05130684] | Phase 2 | 43 participants (Anticipated) | Interventional | 2021-02-22 | Recruiting |
Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer [NCT03308604] | Phase 1 | 18 participants (Anticipated) | Interventional | 2018-05-17 | Recruiting |
A Phase II Study of Induction Chemotherapy Followed by Surgical Treatment in Locally Advanced Oropharyngeal And Supraglotic Cell Carcinoma [NCT02760667] | Phase 2 | 20 participants (Actual) | Interventional | 2015-06-30 | Active, 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 4 | 30 participants (Anticipated) | Interventional | 2021-05-30 | Recruiting |
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 2 | 195 participants (Actual) | Interventional | 2009-04-30 | Completed |
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 1 | 15 participants (Actual) | Interventional | 2014-07-31 | Terminated(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 2 | 50 participants (Actual) | Interventional | 2004-01-28 | Active, not recruiting |
A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas [NCT00005088] | Phase 2 | 0 participants | Interventional | 2000-04-30 | Completed |
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 1 | 0 participants (Actual) | Interventional | 2014-01-31 | Withdrawn(stopped due to Financial Sponsor requested termination) |
[NCT01483300] | Phase 2 | 80 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
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 2 | 69 participants (Anticipated) | Interventional | 2008-01-31 | Recruiting |
Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors [NCT00066482] | | 19 participants (Actual) | Interventional | 2004-07-31 | Completed |
Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer [NCT00248482] | Phase 2 | 6 participants (Actual) | Interventional | 2002-02-28 | Completed |
A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors [NCT00415324] | Phase 1 | 36 participants (Actual) | Interventional | 2006-12-31 | Completed |
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 3 | 439 participants (Actual) | Interventional | 2002-12-31 | Completed |
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 2 | 50 participants (Actual) | Interventional | 2005-06-30 | Terminated(stopped due to no patient recruitment) |
[NCT00083252] | Phase 2 | 0 participants | Interventional | | Completed |
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 2 | 216 participants (Anticipated) | Interventional | 2023-12-01 | Not 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 2 | 29 participants (Actual) | Interventional | 2012-11-30 | Completed |
CRP on Radiobiological and Clinical Studies on Viral-induced Cancer's Response to Radiotherapy With Comprehensive Morbidity Assessment [NCT00122772] | Phase 3 | 601 participants (Actual) | Interventional | 2005-11-30 | Completed |
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 2 | 65 participants (Actual) | Interventional | 2004-08-31 | Completed |
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 3 | 67 participants (Actual) | Interventional | 2002-10-31 | Completed |
"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 2 | 96 participants (Actual) | Interventional | 2016-04-13 | Active, 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 1 | 21 participants (Anticipated) | Interventional | 2023-07-17 | Recruiting |
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 1 | 20 participants (Actual) | Interventional | 2003-09-30 | Completed |
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 1 | 0 participants | Interventional | 2007-01-31 | Terminated(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 1 | 34 participants (Actual) | Interventional | 2012-10-01 | Completed |
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 2 | 99 participants (Anticipated) | Interventional | 2005-12-31 | Completed |
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 1 | 10 participants (Actual) | Interventional | 2007-02-28 | Completed |
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 3 | 372 participants (Anticipated) | Interventional | 2006-06-30 | Completed |
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 3 | 500 participants (Actual) | Interventional | 2007-06-30 | Completed |
A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer [NCT00405405] | Phase 1 | 13 participants (Actual) | Interventional | 2006-12-31 | Completed |
A Randomized Phase II Trial Evaluating Chemotherapy Plus Atezolizumab vs Chemotherapy Plus Bevacizumab and Atezolizumab in Advanced Combined Hepatocellular Carcinoma-Cholangiocarcinoma [NCT05211323] | Phase 2 | 88 participants (Anticipated) | Interventional | 2022-12-07 | Recruiting |
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 2 | 4 participants (Actual) | Interventional | 2002-02-28 | Terminated(stopped due to Slow accrual.) |
Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC) [NCT05514912] | Phase 2 | 0 participants (Actual) | Interventional | 2024-03-01 | Withdrawn(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 3 | 590 participants (Anticipated) | Interventional | 2019-10-09 | Suspended(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 3 | 140 participants (Actual) | Interventional | 1995-11-30 | Completed |
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 2 | 20 participants (Actual) | Interventional | 2007-07-31 | Completed |
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 2 | 130 participants (Actual) | Interventional | 2013-03-31 | Completed |
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 2 | 20 participants (Actual) | Interventional | 2014-06-10 | Terminated(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 2 | 100 participants (Anticipated) | Interventional | 2022-09-02 | Recruiting |
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 2 | 557 participants (Actual) | Interventional | 2016-12-19 | Completed |
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 2 | 40 participants (Anticipated) | Interventional | 2021-03-01 | Not 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 2 | 5 participants (Actual) | Interventional | 2007-12-31 | Terminated(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 2 | 63 participants (Actual) | Interventional | 2013-02-01 | Completed |
Sun Yat-sen Memorial Hospital, Sun Yat-sen University [NCT05444673] | Phase 4 | 30 participants (Anticipated) | Interventional | 2022-06-01 | Recruiting |
Phase I Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck [NCT02474368] | Phase 1 | 21 participants (Actual) | Interventional | 2015-11-30 | Active, 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 3 | 70 participants (Actual) | Interventional | 2008-12-08 | Active, not recruiting |
A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer [NCT01674842] | Phase 1 | 55 participants (Actual) | Interventional | 2012-10-31 | Completed |
Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy [NCT00005840] | Phase 1 | 35 participants (Actual) | Interventional | 2000-07-31 | Completed |
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 2 | 13 participants (Actual) | Interventional | 2003-02-28 | Terminated(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 2 | 100 participants (Anticipated) | Interventional | 2021-05-01 | Not 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 3 | 281 participants (Actual) | Interventional | 2002-09-30 | Completed |
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 2 | 45 participants (Anticipated) | Interventional | 2007-11-30 | Recruiting |
A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer [NCT00548821] | Phase 3 | 0 participants | Interventional | | Not yet recruiting |
Phase I Clinical and Pharmacokinetic Study of CBP501 and Cisplatin Every 3 Weeks in Patients With Advanced Refractory Solid Tumors [NCT00551512] | Phase 1 | 48 participants (Actual) | Interventional | 2006-11-30 | Completed |
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 3 | 788 participants (Actual) | Interventional | 2007-01-11 | Active, 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 2 | 86 participants (Actual) | Interventional | 2016-10-31 | Active, 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 2 | 88 participants (Anticipated) | Interventional | 2021-11-09 | Recruiting |
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study [NCT04900623] | Phase 2 | 75 participants (Anticipated) | Interventional | 2021-07-02 | Recruiting |
A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion [NCT04255771] | Phase 3 | 200 participants (Anticipated) | Interventional | 2020-03-01 | Not 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 1 | 17 participants (Actual) | Interventional | 2006-08-31 | Completed |
DREAM3R: DuRvalumab (MEDI4736) With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma - A Phase 3 Randomised Trial [NCT04334759] | Phase 3 | 214 participants (Actual) | Interventional | 2021-02-18 | Active, 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 3 | 486 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor [NCT00483093] | Phase 1 | 22 participants (Actual) | Interventional | 2007-07-31 | Completed |
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 1 | 51 participants (Actual) | Interventional | 2005-03-31 | Completed |
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer [NCT04692051] | Phase 2 | 100 participants (Anticipated) | Interventional | 2019-09-01 | Recruiting |
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 3 | 342 participants (Anticipated) | Interventional | 2017-01-20 | Recruiting |
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 3 | 91 participants (Actual) | Interventional | 2007-08-06 | Active, 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 2 | 37 participants (Actual) | Interventional | 2011-02-28 | Completed |
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 3 | 362 participants (Actual) | Interventional | 2012-02-21 | Completed |
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 3 | 400 participants (Anticipated) | Interventional | 2012-04-30 | Recruiting |
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 2 | 2 participants (Actual) | Interventional | 2010-08-31 | Terminated(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 3 | 70 participants (Actual) | Interventional | 2011-10-13 | Active, 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 2 | 61 participants | Interventional | 2004-12-31 | Completed |
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 3 | 120 participants (Anticipated) | Interventional | 2005-02-28 | Completed |
Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors [NCT00116896] | Phase 1 | 25 participants | Interventional | 2003-06-30 | Completed |
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 3 | 760 participants | Interventional | 2001-04-30 | Completed |
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 4 | 450 participants (Anticipated) | Interventional | 2002-07-31 | Completed |
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 3 | 0 participants | Interventional | 2003-02-28 | Terminated |
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 2 | 27 participants (Actual) | Interventional | 2002-01-31 | Completed |
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 2 | 120 participants (Anticipated) | Interventional | 2010-10-31 | Active, 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 2 | 41 participants | Interventional | 2003-10-31 | Completed |
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma [NCT00077545] | Phase 2 | 39 participants (Anticipated) | Interventional | 2004-01-31 | Completed |
Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis [NCT03079427] | Phase 2 | 101 participants (Actual) | Interventional | 2017-05-15 | Completed |
A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers [NCT00011960] | Phase 2 | 0 participants | Interventional | 2001-05-31 | Completed |
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 2 | 70 participants (Actual) | Interventional | 2001-03-31 | Completed |
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 2 | 22 participants (Actual) | Interventional | 1999-05-13 | Completed |
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 1 | 0 participants | Interventional | 2000-12-31 | Completed |
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 3 | 8 participants (Actual) | Interventional | 2001-07-31 | Completed |
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 2 | 29 participants (Actual) | Interventional | 1999-09-30 | Completed |
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 3 | 172 participants (Anticipated) | Interventional | 2022-07-01 | Not yet recruiting |
A Phase I Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer. [NCT00846443] | Phase 1 | 12 participants (Anticipated) | Interventional | 2009-01-31 | Recruiting |
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 2 | 29 participants (Actual) | Interventional | 2017-04-19 | Completed |
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 3 | 349 participants (Actual) | Interventional | 2017-03-01 | Completed |
An Exploratory Phase II Clinical Trial of Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Cancer [NCT05772377] | Phase 2 | 36 participants (Anticipated) | Interventional | 2023-07-01 | Not 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 1 | 0 participants | Interventional | 2001-03-31 | Completed |
A Phase I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function [NCT00398424] | Phase 1 | 24 participants (Anticipated) | Interventional | 2006-02-28 | Completed |
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 3 | 932 participants (Actual) | Interventional | 2012-07-31 | Completed |
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 2 | 116 participants (Actual) | Interventional | 2003-05-31 | Completed |
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 3 | 180 participants (Anticipated) | Interventional | 2005-07-31 | Completed |
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 2 | 30 participants (Anticipated) | Interventional | 2003-12-31 | Completed |
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 2 | 21 participants (Actual) | Interventional | 2003-07-31 | Completed |
Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients [NCT00122746] | Phase 3 | 322 participants (Anticipated) | Interventional | 2004-12-31 | Recruiting |
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 2 | 50 participants (Anticipated) | Interventional | 2004-02-29 | Completed |
Phase I Trial of Cisplatin, Pemetrexed, and Imatinib Mesylate in Unresectable or Metastatic Malignant Mesothelioma [NCT00402766] | Phase 1 | 19 participants (Actual) | Interventional | 2006-08-31 | Completed |
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 2 | 48 participants (Actual) | Interventional | 2005-07-31 | Completed |
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse [NCT00147160] | Phase 2 | 87 participants (Anticipated) | Interventional | 2003-10-31 | Completed |
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 2 | 40 participants (Actual) | Interventional | 2001-08-31 | Completed |
Weekly Low-dose Paclitaxel (Phyxol) Plus 24-Hour Infusion of Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer [NCT00154882] | Phase 2 | 43 participants (Anticipated) | Interventional | 2003-09-30 | Recruiting |
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 2 | 40 participants (Actual) | Interventional | 2001-02-28 | Completed |
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 2 | 97 participants (Actual) | Interventional | 2004-09-30 | Completed |
Clinical Study of Toripalimab Combined With Anlotinib, Etoposide and Platinum in the Treatment of Extensive-stage Small Cell Lung Cancer [NCT04731909] | | 80 participants (Anticipated) | Interventional | 2018-10-01 | Recruiting |
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 2 | 72 participants (Actual) | Interventional | 2004-03-31 | Completed |
Prospective Phase I/II Study of Adjuvant Radiochemotherapy for Gastric Cancer [NCT00188266] | Phase 1/Phase 2 | 65 participants (Anticipated) | Interventional | 2002-08-31 | Completed |
Lipiodol-based Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Cisplatin Particle Suspension [NCT03268499] | Phase 2 | 77 participants (Actual) | Interventional | 2016-09-09 | Completed |
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 3 | 220 participants (Actual) | Interventional | 2003-07-07 | Completed |
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study [NCT00198367] | Phase 2 | 120 participants (Actual) | Interventional | 2003-01-31 | Completed |
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07) [NCT01614132] | Phase 1/Phase 2 | 33 participants (Actual) | Interventional | 2009-01-31 | Completed |
Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy [NCT02432365] | Phase 2 | 64 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer [NCT01016561] | | 12 participants (Actual) | Interventional | 2009-07-31 | Terminated(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 2 | 60 participants (Anticipated) | Interventional | 2023-05-23 | Recruiting |
Adaptive-Dose to Mediastinum With Immunotherapy (Durvalumab MEDI4736) and Radiation in Locally-Advanced Non-Small Cell Lung Cancer [NCT04372927] | Phase 2 | 1 participants (Actual) | Interventional | 2021-12-10 | Terminated(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 2 | 60 participants (Actual) | Interventional | 2007-06-30 | Completed |
A Phase II Trial of Combination of Toripalimab and Definitive Chemoradiotherapy in Esophageal Squamous Cell Carcinoma [NCT04005170] | Phase 2 | 42 participants (Actual) | Interventional | 2019-06-25 | Completed |
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 2 | 68 participants (Actual) | Interventional | 2021-03-22 | Active, not recruiting |
Durvalumab and Standard Chemotherapy for the Treatment of Lymph Node Positive Bladder Cancer [NCT05137262] | Phase 2 | 60 participants (Anticipated) | Interventional | 2021-10-13 | Recruiting |
Phase II Trial of Durvalumab (MEDI4736) Maintenance Therapy After Concurrent Chemoradiation Therapy With Durvalumab (MEDI4736) for Limited Disease-small Cell Lung Cancer [NCT03585998] | Phase 2 | 51 participants (Actual) | Interventional | 2018-06-19 | Active, 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 2 | 21 participants (Actual) | Interventional | 2006-01-31 | Terminated(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 2 | 111 participants (Actual) | Interventional | 2006-10-23 | Completed |
A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma [NCT04405154] | Phase 2 | 32 participants (Anticipated) | Interventional | 2020-06-01 | Not 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 2 | 107 participants (Anticipated) | Interventional | 2012-05-15 | Active, not recruiting |
Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial [NCT04559139] | Phase 2/Phase 3 | 186 participants (Anticipated) | Interventional | 2021-02-24 | Recruiting |
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 2 | 25 participants (Actual) | Interventional | 2013-05-31 | Completed |
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 1 | 15 participants (Actual) | Interventional | 2007-09-30 | Completed |
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 3 | 65 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years [NCT02986503] | | 100 participants (Actual) | Observational | 2002-01-31 | Completed |
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 2 | 66 participants (Anticipated) | Interventional | 2013-03-31 | Recruiting |
Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma [NCT06019130] | Phase 2 | 57 participants (Anticipated) | Interventional | 2023-01-10 | Recruiting |
Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study [NCT00304070] | Phase 3 | 78 participants (Actual) | Interventional | 2007-05-03 | Completed |
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 3 | 590 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting |
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 2 | 6 participants (Actual) | Interventional | 2014-03-31 | Terminated(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 1 | 15 participants (Actual) | Interventional | 2016-11-30 | Completed |
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer [NCT01487499] | Phase 3 | 4 participants (Actual) | Interventional | 2011-12-31 | Terminated(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 1 | 23 participants (Actual) | Interventional | 2017-04-26 | Completed |
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 3 | 1,615 participants (Anticipated) | Interventional | 2021-11-11 | Recruiting |
Phase III Study Of Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients [NCT00201383] | Phase 3 | 161 participants | Interventional | 1999-10-31 | Completed |
A Randomized Phase 2 Trial of Cisplatin/Gemcitabine With or Without M6620 (VX-970) in Metastatic Urothelial Carcinoma [NCT02567409] | Phase 2 | 87 participants (Actual) | Interventional | 2016-08-19 | Active, 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 2 | 47 participants (Actual) | Interventional | 2012-11-30 | Completed |
A Phase 2 Study of Neoadjuvant Pembrolizumab-Based Combination Immunotherapy in the Treatment of Early Stage Non-Small Cell Lung Cancer [NCT04061590] | Phase 2 | 0 participants (Actual) | Interventional | 2020-05-29 | Withdrawn(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 3 | 536 participants (Anticipated) | Interventional | 2015-06-02 | Recruiting |
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 2 | 88 participants (Actual) | Interventional | 2005-05-31 | Completed |
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 3 | 324 participants (Actual) | Interventional | 2005-05-31 | Completed |
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 2 | 43 participants (Anticipated) | Interventional | 2005-10-31 | Recruiting |
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 2 | 114 participants (Anticipated) | Interventional | 2023-07-25 | Recruiting |
A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER) [NCT03509012] | Phase 1 | 105 participants (Actual) | Interventional | 2018-05-02 | Active, not recruiting |
Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment [NCT00505635] | Phase 2 | 5 participants (Actual) | Interventional | 2007-03-31 | Terminated(stopped due to Slow accrual) |
[NCT00301301] | | 39 participants | Observational | | Completed |
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 2 | 35 participants (Actual) | Interventional | 2013-11-30 | Completed |
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 2 | 0 participants | Interventional | 2006-04-30 | Completed |
A Phase II Trial of Durvalumab With Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma [NCT06050252] | Phase 2 | 27 participants (Anticipated) | Interventional | 2024-02-16 | Not 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 2 | 156 participants (Anticipated) | Interventional | 2024-02-16 | Not 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 4 | 200 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
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 2 | 40 participants (Anticipated) | Interventional | 2013-02-28 | Recruiting |
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 2 | 144 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting |
Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland [NCT01630226] | Phase 2 | 100 participants (Anticipated) | Interventional | 2007-06-30 | Recruiting |
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 3 | 96 participants (Actual) | Interventional | 2014-12-31 | Completed |
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 2 | 40 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma [NCT01650090] | Phase 2 | 28 participants (Actual) | Interventional | 2012-08-31 | Completed |
Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma [NCT01655628] | Phase 2 | 40 participants (Anticipated) | Interventional | 2012-07-31 | Recruiting |
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 3 | 4 participants (Actual) | Interventional | 2012-08-31 | Terminated(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 2 | 100 participants (Anticipated) | Interventional | 2012-12-14 | Active, 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 2 | 73 participants (Actual) | Interventional | 2012-11-30 | Completed |
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 1 | 12 participants (Actual) | Interventional | 2013-01-31 | Completed |
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 2 | 0 participants | Interventional | 2012-11-30 | Recruiting |
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 4 | 45 participants (Actual) | Interventional | 2014-01-31 | Completed |
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 3 | 189 participants (Anticipated) | Interventional | 2022-06-28 | Recruiting |
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 2 | 120 participants (Anticipated) | Interventional | 2021-07-15 | Active, 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 3 | 80 participants (Anticipated) | Interventional | 2021-09-12 | Recruiting |
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 2 | 82 participants (Anticipated) | Interventional | 2019-03-12 | Recruiting |
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 3 | 300 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
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 3 | 200 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer [NCT01801644] | | 60 participants (Actual) | Interventional | 2007-04-30 | Completed |
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 2 | 84 participants (Actual) | Interventional | 2011-12-31 | Completed |
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 2 | 126 participants (Anticipated) | Interventional | 2024-06-01 | Not yet recruiting |
A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma [NCT02256982] | | 3 participants (Actual) | Interventional | 2014-10-31 | Terminated(stopped due to Slow accrual.) |
Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy [NCT01687413] | Phase 3 | 42 participants (Actual) | Interventional | 2013-01-10 | Terminated(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 2 | 25 participants (Anticipated) | Interventional | 2013-07-23 | Active, 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 2 | 40 participants (Anticipated) | Interventional | 2021-02-16 | Active, 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 2 | 40 participants (Actual) | Interventional | 2021-09-22 | Completed |
Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression [NCT01828736] | Phase 2 | 61 participants (Actual) | Interventional | 2004-02-09 | Completed |
Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity [NCT01829178] | Phase 2/Phase 3 | 30 participants (Actual) | Interventional | 2013-08-31 | Completed |
Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation [NCT01843647] | Phase 2 | 100 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting |
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 2 | 50 participants (Anticipated) | Interventional | 2021-09-01 | Recruiting |
RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC [NCT04849377] | Phase 2 | 0 participants (Actual) | Interventional | 2022-06-14 | Withdrawn(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 2 | 120 participants (Anticipated) | Interventional | 2022-08-30 | Recruiting |
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 3 | 320 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
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 3 | 562 participants (Anticipated) | Interventional | 2020-06-01 | Not 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 2 | 101 participants (Actual) | Interventional | 2003-01-31 | Completed |
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) | Observational | 2020-07-01 | Recruiting |
A Phase I/1b Study of Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer [NCT02300610] | Phase 1 | 10 participants (Actual) | Interventional | 2015-02-11 | Completed |
Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy [NCT00379665] | Phase 2 | 25 participants (Actual) | Interventional | 2005-10-31 | Completed |
Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis [NCT00001569] | Phase 1 | 74 participants | Interventional | 1997-01-31 | Completed |
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 2 | 300 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
Efficacy and Safety of Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-001) [NCT04389177] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-07-08 | Active, 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 2 | 84 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers [NCT05075980] | Phase 2 | 117 participants (Anticipated) | Interventional | 2022-02-16 | Recruiting |
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis [NCT04858009] | Phase 2 | 40 participants (Anticipated) | Interventional | 2023-12-31 | Not 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 2 | 40 participants (Actual) | Interventional | 2012-06-30 | Active, not recruiting |
A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer [NCT01461759] | Phase 2 | 59 participants (Anticipated) | Interventional | 2011-10-31 | Recruiting |
Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma [NCT01462474] | Phase 1 | 20 participants (Actual) | Interventional | 2011-10-31 | Completed |
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 1 | 70 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03020329] | Phase 2 | 37 participants (Anticipated) | Interventional | 2016-11-14 | Recruiting |
A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer [NCT01924819] | Phase 2/Phase 3 | 574 participants (Actual) | Interventional | 2009-09-30 | Active, not recruiting |
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903) [NCT04138212] | Phase 3 | 456 participants (Anticipated) | Interventional | 2019-10-22 | Recruiting |
Neoadjuvant Therapy of Camrelizumab Combined With Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Single-arm, Phase II Clinical Study [NCT05476380] | Phase 2 | 39 participants (Anticipated) | Interventional | 2021-02-19 | Recruiting |
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial [NCT02143388] | Phase 3 | 180 participants (Actual) | Interventional | 2014-03-31 | Completed |
Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation [NCT01151761] | Phase 2 | 2 participants (Actual) | Interventional | 2011-01-31 | Terminated(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 2 | 58 participants | Interventional | 1995-09-30 | Completed |
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 2 | 70 participants (Anticipated) | Interventional | 2023-01-18 | Recruiting |
Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck [NCT00002932] | Phase 2 | 60 participants (Anticipated) | Interventional | 1997-05-31 | Completed |
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 2 | 25 participants (Anticipated) | Interventional | 2015-09-04 | Suspended |
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 3 | 500 participants (Anticipated) | Interventional | 2014-02-28 | Recruiting |
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 3 | 184 participants (Actual) | Interventional | 1995-09-26 | Completed |
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 3 | 384 participants (Anticipated) | Interventional | 1998-03-31 | Completed |
Camrelizumab Plus Cisplatin in Advanced Cutaneous Squamous Cell Carcinoma: a Single-arm, Open, Single-center Phase II Study [NCT05490485] | Phase 2 | 20 participants (Anticipated) | Interventional | 2022-08-05 | Recruiting |
A Phase II Study of Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Gastric Carcinomatosis or Positive Cytology [NCT02092298] | Phase 2 | 21 participants (Actual) | Interventional | 2014-05-08 | Completed |
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 3 | 364 participants (Anticipated) | Interventional | 2021-03-01 | Not 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 3 | 110 participants (Anticipated) | Interventional | 2019-12-16 | Recruiting |
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma [NCT00602667] | Phase 2 | 293 participants (Actual) | Interventional | 2007-12-17 | Active, 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 2 | 288 participants (Actual) | Interventional | 2009-11-30 | Completed |
An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer [NCT00085631] | Phase 3 | 101 participants (Actual) | Interventional | 2003-03-31 | Terminated(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 3 | 120 participants (Anticipated) | Interventional | 2017-03-31 | Not 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 3 | 97 participants (Actual) | Interventional | 2001-06-30 | Completed |
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 2 | 60 participants (Anticipated) | Interventional | 2022-08-25 | Recruiting |
Electrochemotherapy of Gynecological Cancers [NCT04760327] | Phase 2 | 30 participants (Anticipated) | Interventional | 2020-07-01 | Recruiting |
A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [NCT02392637] | Phase 2 | 62 participants (Actual) | Interventional | 2015-04-02 | Completed |
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma [NCT03215719] | Phase 2 | 144 participants (Anticipated) | Interventional | 2017-07-10 | Recruiting |
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 2 | 40 participants (Anticipated) | Interventional | 2020-11-01 | Recruiting |
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 3 | 341 participants (Anticipated) | Interventional | 2021-03-31 | Not 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 2 | 29 participants (Actual) | Interventional | 2002-05-31 | Completed |
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 3 | 668 participants (Actual) | Interventional | 1998-08-31 | Completed |
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 2 | 30 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer [NCT01590017] | Phase 2 | 41 participants (Actual) | Interventional | 2014-04-01 | Completed |
Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma [NCT03377400] | Phase 2 | 40 participants (Anticipated) | Interventional | 2017-12-14 | Active, 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 3 | 200 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting |
Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03366415] | Phase 3 | 420 participants (Anticipated) | Interventional | 2018-01-01 | Recruiting |
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 3 | 396 participants (Actual) | Interventional | 2020-06-30 | Active, 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 2 | 50 participants (Anticipated) | Interventional | 2022-08-31 | Not 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 2 | 126 participants (Anticipated) | Interventional | 2022-08-31 | Not 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 2 | 20 participants (Anticipated) | Interventional | 2020-05-01 | Not yet recruiting |
A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide [NCT03275857] | Early Phase 1 | 37 participants (Anticipated) | Interventional | 2018-09-21 | Recruiting |
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 3 | 440 participants (Anticipated) | Interventional | 2022-11-11 | Recruiting |
Chemo-embolization for Head and Neck Cancer [NCT04595981] | Phase 2 | 48 participants (Anticipated) | Interventional | 2021-03-10 | Active, not recruiting |
Randomized Phase III Clinical Trial of Weekly Versus Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer [NCT01561586] | Phase 3 | 374 participants (Anticipated) | Interventional | 2012-03-31 | Recruiting |
[NCT01593306] | Phase 3 | 80 participants (Anticipated) | Interventional | 2011-07-31 | Recruiting |
Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer [NCT01594099] | Phase 2 | 45 participants (Anticipated) | Interventional | 2012-04-30 | Active, not recruiting |
Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy [NCT01362127] | Phase 2 | 181 participants (Actual) | Interventional | 2006-10-31 | Completed |
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 2 | 60 participants (Anticipated) | Interventional | 2012-05-31 | Completed |
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 1 | 20 participants (Actual) | Interventional | 2014-07-16 | Completed |
Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer [NCT01611727] | Phase 2 | 20 participants (Actual) | Interventional | 2007-07-31 | Completed |
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 2 | 8 participants (Actual) | Interventional | 2018-11-08 | Completed |
Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma [NCT01614938] | Phase 2 | 46 participants (Actual) | Interventional | 2010-08-31 | Active, 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 2 | 28 participants (Actual) | Interventional | 2012-05-31 | Active, 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 2 | 27 participants (Anticipated) | Interventional | 2021-11-12 | Recruiting |
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 3 | 610 participants (Anticipated) | Interventional | 2015-07-31 | Recruiting |
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 2 | 117 participants (Actual) | Interventional | 2014-05-12 | Completed |
Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma [NCT00347256] | | 60 participants (Anticipated) | Interventional | | Withdrawn |
Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy [NCT01275664] | | 4 participants (Actual) | Interventional | 2011-06-30 | Terminated(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 4 | 733 participants (Actual) | Interventional | 2018-01-31 | Completed |
Randomized Phase 2 Trial of Tirapazamine and the Role of Tumor Hypoxia in Advanced Squamous Head and Neck Cancer [NCT00002774] | Phase 2 | 63 participants (Actual) | Interventional | 1996-06-30 | Completed |
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 2 | 30 participants (Anticipated) | Interventional | 2006-11-30 | Recruiting |
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 2 | 55 participants (Anticipated) | Interventional | 1996-09-30 | Active, 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 3 | 120 participants (Anticipated) | Interventional | 1995-05-31 | Active, 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 3 | 421 participants (Actual) | Interventional | 1996-12-31 | Completed |
Protocol for Patients With Newly-Diagnosed Non-Metastatic Osteosarcoma - A POG/CCG Pilot Intergroup Study [NCT00003937] | Phase 3 | 253 participants (Actual) | Interventional | 1999-09-30 | Completed |
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 1 | 40 participants (Actual) | Interventional | 1999-10-31 | Completed |
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 2 | 40 participants (Anticipated) | Interventional | 1999-11-30 | Completed |
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 2 | 43 participants (Actual) | Interventional | 2004-11-30 | Terminated(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 3 | 28 participants (Actual) | Interventional | 2014-11-12 | Terminated(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 2 | 50 participants | Interventional | 1996-03-31 | Completed |
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 1 | 24 participants (Anticipated) | Interventional | 1995-10-31 | Completed |
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 3 | 324 participants (Anticipated) | Interventional | 1996-03-31 | Completed |
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 2 | 68 participants (Actual) | Interventional | 1996-04-30 | Terminated(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 2 | 45 participants (Anticipated) | Interventional | 2022-09-02 | Recruiting |
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 2 | 350 participants (Anticipated) | Interventional | 2022-04-14 | Recruiting |
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 2 | 25 participants (Anticipated) | Interventional | 1997-08-31 | Completed |
A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors [NCT00003141] | Phase 1 | 94 participants (Actual) | Interventional | 1998-03-31 | Completed |
A Phase 1-2 Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer [NCT01938573] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2013-10-31 | Completed |
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 3 | 549 participants (Actual) | Interventional | 2004-04-30 | Active, 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 1 | 30 participants (Anticipated) | Interventional | 2021-02-15 | Recruiting |
A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas [NCT01726582] | Phase 2 | 229 participants (Actual) | Interventional | 2011-11-30 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2022-05-31 | Withdrawn(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 2 | 78 participants (Anticipated) | Interventional | 2021-01-05 | Recruiting |
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 3 | 501 participants (Actual) | Interventional | 2020-04-07 | Active, 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 2 | 519 participants (Actual) | Interventional | 2014-01-22 | Active, not recruiting |
Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma [NCT00316888] | Phase 2 | 63 participants (Actual) | Interventional | 2007-02-28 | Completed |
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 2 | 69 participants (Actual) | Interventional | 2005-04-08 | Completed |
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 2 | 97 participants (Actual) | Interventional | 2002-08-15 | Completed |
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) | Observational | 2020-09-01 | Recruiting |
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835] | Phase 3 | 116 participants (Actual) | Interventional | 1995-10-30 | Completed |
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 2 | 53 participants (Actual) | Interventional | 1998-11-30 | Completed |
A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer [NCT00004083] | Phase 2 | 0 participants | Interventional | 1999-02-28 | Completed |
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 2 | 90 participants (Anticipated) | Interventional | 2020-08-25 | Recruiting |
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 2 | 69 participants (Actual) | Interventional | 2013-02-28 | Completed |
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 3 | 540 participants (Actual) | Interventional | 2010-04-30 | Completed |
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 2 | 57 participants (Anticipated) | Interventional | 2023-04-10 | Recruiting |
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 2 | 99 participants (Anticipated) | Interventional | 2020-07-16 | Recruiting |
Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer [NCT05406674] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-06-15 | Recruiting |
A Single-arm Exploratory Clinical Study of Envafolimab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer [NCT05799469] | Phase 2 | 36 participants (Anticipated) | Interventional | 2023-05-01 | Not 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 2 | 324 participants (Actual) | Interventional | 2016-02-15 | Completed |
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 3 | 147 participants (Anticipated) | Interventional | 2014-11-30 | Enrolling 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 3 | 236 participants (Anticipated) | Interventional | 2014-01-09 | Recruiting |
Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial [NCT03071289] | Phase 3 | 540 participants (Anticipated) | Interventional | 2017-06-01 | Recruiting |
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial [NCT02461043] | Phase 3 | 386 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
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 2 | 40 participants (Anticipated) | Interventional | 2021-07-01 | Not 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 2 | 164 participants (Anticipated) | Interventional | 2017-02-04 | Active, not recruiting |
Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma [NCT03042429] | Phase 3 | 360 participants (Actual) | Interventional | 2007-01-01 | Completed |
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 2 | 65 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
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 2 | 53 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
Phase II Trial To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix [NCT04789941] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-04-01 | Not 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 3 | 366 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
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 2 | 144 participants (Anticipated) | Interventional | 2016-08-19 | Recruiting |
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 2 | 240 participants (Actual) | Interventional | 2014-02-28 | Completed |
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 1 | 9 participants (Actual) | Interventional | 2012-08-31 | Terminated(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 2 | 178 participants (Anticipated) | Interventional | 2016-12-01 | Recruiting |
Effect of Refnot on Immunity in Cancer Patients [NCT05898451] | Phase 2 | 55 participants (Actual) | Interventional | 2009-06-04 | Completed |
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer [NCT03100955] | Phase 3 | 120 participants (Anticipated) | Interventional | 2017-03-01 | Recruiting |
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 2 | 11 participants (Actual) | Interventional | 2013-09-30 | Terminated(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 2 | 136 participants (Anticipated) | Interventional | 2023-04-25 | Recruiting |
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 1 | 61 participants (Actual) | Interventional | 2015-09-03 | Terminated(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 2 | 80 participants (Anticipated) | Interventional | 2022-06-08 | Recruiting |
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) | Observational | 2021-12-13 | Recruiting |
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 2 | 71 participants (Anticipated) | Interventional | 2021-11-18 | Recruiting |
Induction Durvalumab Followed by Chemoradiation and Consolidation Durvalumab (MEDI4736) for Stage III Non-small Cell Lung Cancer [NCT04364048] | Phase 2 | 10 participants (Actual) | Interventional | 2020-06-18 | Active, 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) | Interventional | 2017-06-30 | Completed |
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 2 | 147 participants (Actual) | Interventional | 2014-04-30 | Completed |
Phase II Trial of Post-Operative Adjuvant Paclitaxel + Cisplatin in Patients With Adenocarcinoma of the Esophagus, Gastro-Esophageal Junction or Cardia [NCT00003237] | Phase 2 | 55 participants (Anticipated) | Interventional | 1998-06-22 | Completed |
Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer [NCT05492123] | Phase 2 | 112 participants (Anticipated) | Interventional | 2022-08-30 | Recruiting |
BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001 [NCT00522795] | Phase 2 | 40 participants (Actual) | Interventional | 2007-08-31 | Completed |
A Phase I, Open-Label Study Evaluating the Pharmacokinetics of Components of S-1 in Patients With Varying Degrees of Renal Function [NCT00398307] | Phase 1 | 24 participants (Anticipated) | Interventional | 2006-02-28 | Completed |
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 2 | 66 participants (Anticipated) | Interventional | 2020-08-14 | Recruiting |
Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX) [NCT03255252] | Phase 2 | 29 participants (Actual) | Interventional | 2017-07-15 | Active, 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 2 | 24 participants (Actual) | Interventional | 2012-10-22 | Completed |
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 3 | 1,334 participants (Actual) | Interventional | 2005-11-14 | Completed |
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC) [NCT01822496] | Phase 2 | 59 participants (Actual) | Interventional | 2013-11-04 | Terminated |
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 2 | 120 participants (Anticipated) | Interventional | 2012-08-31 | Recruiting |
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 2 | 118 participants (Actual) | Interventional | 2012-10-31 | Active, 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 2 | 25 participants (Actual) | Interventional | 2003-02-28 | Completed |
Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma: A Exploratory Clinical Trial [NCT04413734] | Phase 2 | 120 participants (Anticipated) | Interventional | 2020-04-22 | Recruiting |
Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas [NCT00083122] | Phase 2 | 45 participants (Actual) | Interventional | 2004-04-30 | Completed |
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 2 | 53 participants (Actual) | Interventional | 2019-03-13 | Terminated(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 2 | 27 participants (Actual) | Interventional | 2017-12-15 | Completed |
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 2 | 24 participants (Actual) | Interventional | 2017-05-23 | Active, 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 3 | 330 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
A Phase I Study of Methoxyamine Combined With Chemo-Radiation for Locally Advanced Non-Squamous Non-Small Cell Lung Cancer [NCT02535325] | Phase 1 | 17 participants (Actual) | Interventional | 2015-09-30 | Completed |
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 2 | 9 participants (Actual) | Interventional | 2012-12-31 | Terminated(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 3 | 1,861 participants (Actual) | Interventional | 2004-10-31 | Completed |
A Prospective, Single Arm, Single Center, Phase II Clinical Trial of Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell [NCT04520035] | Phase 2 | 60 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
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 2 | 55 participants (Anticipated) | Interventional | 2018-03-23 | Recruiting |
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 2 | 51 participants (Anticipated) | Interventional | 2014-12-01 | Recruiting |
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 2 | 69 participants (Actual) | Interventional | 2008-05-31 | Completed |
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 3 | 588 participants (Anticipated) | Interventional | 2022-10-28 | Recruiting |
Comparative Study of Different Doses of Magnesium as a Protective Agent in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer [NCT05586009] | Phase 2 | 75 participants (Anticipated) | Interventional | 2022-10-31 | Enrolling 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 2 | 32 participants (Anticipated) | Interventional | 2023-03-01 | Not 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 3 | 452 participants (Actual) | Interventional | 2009-04-30 | Completed |
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 2 | 63 participants (Actual) | Interventional | 2010-02-08 | Active, 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) | Observational | 2018-05-15 | Completed |
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer [NCT05620654] | Phase 1 | 30 participants (Anticipated) | Interventional | 2022-12-01 | Recruiting |
A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma [NCT01670409] | Phase 2 | 85 participants (Actual) | Interventional | 2012-08-31 | Completed |
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma Based On The AJCC 8th Edition Staging Manual [NCT04638465] | | 150 participants (Anticipated) | Observational | 2018-08-06 | Active, not recruiting |
A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma FRONTiER Trial [NCT03914443] | Phase 1 | 36 participants (Anticipated) | Interventional | 2019-05-07 | Active, not recruiting |
Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma [NCT00085098] | Phase 3 | 24 participants (Actual) | Interventional | 2007-01-31 | Completed |
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 3 | 341 participants (Actual) | Interventional | 2010-04-12 | Active, 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 2 | 3 participants (Actual) | Interventional | 2013-03-31 | Terminated(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 1 | 60 participants (Actual) | Interventional | 2014-09-03 | Completed |
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 2 | 90 participants (Anticipated) | Interventional | 2021-03-25 | Recruiting |
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 3 | 561 participants (Anticipated) | Interventional | 2021-12-30 | Not 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 2 | 33 participants (Anticipated) | Interventional | 2020-11-10 | Active, not recruiting |
Durvalumab With Chemotherapy Followed by Sequential Radiotherapy for Limited Stage Small Cell Lung Cancer: A Single-arm Phase II Trial. [NCT05034133] | Phase 2 | 20 participants (Anticipated) | Interventional | 2021-09-01 | Recruiting |
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 2 | 48 participants (Anticipated) | Interventional | 2021-09-30 | Not 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 2 | 55 participants (Anticipated) | Interventional | 2022-07-13 | Recruiting |
Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol [NCT00003569] | | 2 participants (Actual) | Observational | 1998-03-31 | Completed |
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 2 | 168 participants (Actual) | Interventional | 1998-03-31 | Completed |
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 2 | 105 participants (Actual) | Interventional | 2000-03-31 | Completed |
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 3 | 804 participants (Actual) | Interventional | 2017-04-05 | Active, 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 3 | 545 participants (Actual) | Interventional | 2013-09-19 | Terminated |
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 1 | 74 participants (Anticipated) | Interventional | 2021-08-25 | Active, not recruiting |
A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer [NCT02662634] | Phase 2 | 0 participants (Actual) | Interventional | 2016-03-31 | Withdrawn |
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 3 | 636 participants (Anticipated) | Interventional | 2022-06-21 | Recruiting |
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 2 | 11 participants (Actual) | Interventional | 2007-12-11 | Terminated(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 2 | 22 participants (Actual) | Interventional | 2011-05-09 | Completed |
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 3 | 225 participants (Anticipated) | Interventional | 2018-04-10 | Recruiting |
Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma [NCT03469531] | Phase 2 | 100 participants (Anticipated) | Interventional | 2018-03-20 | Recruiting |
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 1 | 12 participants (Actual) | Interventional | 2015-07-22 | Completed |
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 3 | 105 participants (Anticipated) | Interventional | 2023-09-15 | Not yet recruiting |
LCCC 1612: P53 Mutational Status and Circulating Free HPV DNA for the Management of HPV-associated Oropharyngeal Squamous Cell Cancers [NCT03077243] | Phase 2 | 215 participants (Actual) | Interventional | 2016-12-31 | Active, 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 2 | 60 participants (Anticipated) | Interventional | 2021-12-07 | Recruiting |
PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer [NCT03774732] | Phase 3 | 327 participants (Anticipated) | Interventional | 2019-03-21 | Recruiting |
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 2 | 108 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
"Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma: A Feasibility Phase II Randomized Clinical Trial (URANUS)" [NCT02969083] | Phase 2 | 200 participants (Anticipated) | Interventional | 2018-05-28 | Recruiting |
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 2 | 100 participants (Anticipated) | Interventional | 2014-12-31 | Not 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 1 | 12 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
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 2 | 4 participants (Actual) | Interventional | 2012-03-31 | Terminated(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 2 | 1 participants (Actual) | Interventional | 2015-01-31 | Terminated(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 1 | 50 participants (Anticipated) | Interventional | 2023-08-02 | Recruiting |
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 3 | 382 participants (Actual) | Interventional | 2008-07-31 | Active, not recruiting |
Phase II Study of De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma [NCT01530997] | Phase 2 | 45 participants (Actual) | Interventional | 2012-02-07 | Completed |
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 1 | 7 participants (Actual) | Interventional | 2014-08-20 | Completed |
Salvage Immunotherapy Combined With Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy (SINCERE Study) [NCT05103501] | Phase 2 | 54 participants (Anticipated) | Interventional | 2021-12-01 | Not yet recruiting |
A Phase 2 Study of Combined Chemo-immunotherapy With Cisplatin-pembrolizumab and Radiation for Unresectable Vulvar Squamous Cell Carcinoma [NCT04430699] | Phase 2 | 24 participants (Anticipated) | Interventional | 2020-07-29 | Recruiting |
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 2 | 30 participants (Anticipated) | Interventional | 2017-03-06 | Recruiting |
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 3 | 266 participants (Anticipated) | Interventional | 2021-08-16 | Recruiting |
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 3 | 420 participants (Anticipated) | Interventional | 2018-02-01 | Not yet recruiting |
Phase II Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer [NCT05305131] | Phase 2 | 50 participants (Anticipated) | Interventional | 2022-03-28 | Not 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 3 | 15 participants (Actual) | Interventional | 2020-12-09 | Terminated(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) | Observational | 2011-10-11 | Active, 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 2 | 128 participants (Anticipated) | Interventional | 2010-07-09 | Active, not recruiting |
A Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of the Head and Neck [NCT01275183] | Early Phase 1 | 5 participants (Actual) | Interventional | 2010-12-31 | Completed |
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 3 | 192 participants (Anticipated) | Interventional | 2015-08-31 | Recruiting |
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 3 | 236 participants (Anticipated) | Interventional | 2015-06-30 | Active, 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 3 | 361 participants (Actual) | Interventional | 2011-04-14 | Terminated(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 2 | 6 participants (Actual) | Interventional | 2005-09-30 | Terminated(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 2 | 1,460 participants (Actual) | Interventional | 2014-04-07 | Active, 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 2 | 30 participants (Actual) | Interventional | 2019-05-09 | Active, 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 2 | 20 participants (Actual) | Interventional | 2013-12-16 | Completed |
A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma [NCT02358863] | | 13 participants (Actual) | Interventional | 2015-02-28 | Terminated(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 2 | 225 participants (Anticipated) | Interventional | 2011-06-23 | Active, 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 2 | 202 participants (Anticipated) | Interventional | 2019-04-24 | Recruiting |
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 3 | 440 participants (Actual) | Interventional | 2015-03-31 | Active, 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 3 | 1,094 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
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 2 | 66 participants (Actual) | Interventional | 2017-04-29 | Terminated(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 1 | 20 participants (Actual) | Interventional | 2015-05-11 | Completed |
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 3 | 422 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
Expanded Access Protocol With ABT-888 (Veliparib) in Patients With Metastatic BRCA-Mutation Associated or Triple Negative Breast Cancer [NCT02985658] | | 0 participants | Expanded Access | | No longer available |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
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)
Intervention | percentage of participants (Number) |
---|
Experimental Arm | 0 |
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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
Intervention | years (Median) |
---|
Experimental Arm | 0.68 |
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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)
Intervention | percentage of participants (Number) |
---|
Experimental Arm | 65.8 |
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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
Intervention | years (Median) |
---|
Experimental Arm | 1.55 |
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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
Intervention | participants (Number) |
---|
| Dose Limiting Toxicity(DLT)/Significant Dose Delay | Complications unrelated to treatment |
---|
Arm 1, P I | 0 | 0 |
,Arm 2, P I | 0 | 0 |
,Arm 2, PII | 0 | 1 |
,Arm 3, P I | 2 | 0 |
,Arm 4, P I | 2 | 0 |
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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
Intervention | probability (Mean) |
---|
Arm 2, P I & II | 0.80 |
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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
Intervention | probability (Mean) |
---|
Arm 2, P I & II | 0.65 |
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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.
Intervention | Months (Median) |
---|
Hepatocellular Carcinoma | 2.3 |
Neuroendocrine Hepatic Metastases | 7.2 |
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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.
Intervention | Months (Median) |
---|
Hepatocellular Carcinoma | 12.0 |
Neuroendocrine Hepatic Metastases | 21.2 |
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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
Intervention | Proportion of participants (Number) |
---|
Hepatocellular Carcinoma | 0 |
Neuroendocrine Hepatic Metastases | 0.17 |
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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)
Intervention | Participants (Number) |
---|
Mesothelioma, Low Grade, and Adenocarcinoma | 73 |
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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
Intervention | Participants (Number) |
---|
Peritoneal Mesothelioma | 24 |
Low Grade Mucinous Adenocarcinoma | 18 |
Adenocarcinoma of Gastrointestinal Origin | 6 |
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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.
Intervention | Number 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.
Intervention | Number 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
Intervention | Probability 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
Intervention | Probability 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
Intervention | Months (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
Intervention | percentage 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
Intervention | Months (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.
Intervention | percentage of participants (Number) |
---|
Standard Fractionation RT + Cisplatin | 51.4 |
Accelerated Fractionation RT + Cisplatin | 53.4 |
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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.
Intervention | score on a scale * months (Mean) |
---|
Standard Fractionation RT + Cisplatin | 5.27 |
Accelerated Fractionation RT + Cisplatin | 5.19 |
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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.
Intervention | percentage of participants (Number) |
---|
Standard Fractionation RT + Cisplatin | 25.6 |
Accelerated Fractionation RT + Cisplatin | 28.2 |
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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.
Intervention | percentage of participants (Number) |
---|
Standard Fractionation RT + Cisplatin | 25.5 |
Accelerated Fractionation RT + Cisplatin | 28.7 |
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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.
Intervention | percentage of patients (Number) |
---|
Standard Fractionation RT + Cisplatin | 64.3 |
Accelerated Fractionation RT + Cisplatin | 70.3 |
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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.
Intervention | percentage of participants (Number) |
---|
| Acute | Late |
---|
Accelerated Fractionation RT + Cisplatin | 80.0 | 25.7 |
,Standard Fractionation RT + Cisplatin | 83.7 | 21.1 |
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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.
Intervention | score on a scale * months (Mean) |
---|
Standard Fractionation RT + Cisplatin | 90.48 |
Accelerated Fractionation RT + Cisplatin | 91.77 |
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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.
Intervention | score on a scale * months (Mean) |
---|
Standard Fractionation RT + Cisplatin | 65.81 |
Accelerated Fractionation RT + Cisplatin | 67.10 |
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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.
Intervention | percentage of participants (Number) |
---|
Standard Fractionation RT + Cisplatin | 55.8 |
Accelerated Fractionation RT + Cisplatin | 57.0 |
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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.
Intervention | proportion 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.
Intervention | Months (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
Intervention | Months (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
Intervention | months (Median) |
---|
Arm I | 23.8 |
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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
Intervention | participants (Number) |
---|
| Progression of Disease | Responders | Non-Responders |
---|
Arm I | 2 | 3 | 38 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Grade < 2 Sensory neuropathy | Grade 2 or Higher Sensory Neuropathy | Grade <3 infection with Neutrope | Grade 3 or Higher Infection with Neutropenia | Grade <3 infection without Neutropenia | Grade 3 or Higher Infection without Neutropenia |
---|
Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel) | 167 | 473 | 25 | 615 | 22 | 618 |
,Arm II (Paclitaxel, Carboplatin) | 130 | 534 | 29 | 635 | 13 | 651 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | 6 weeks | 15 weeks | 26 weeks |
---|
Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 39.4 | 35.5 | 35.3 | 39.8 |
,Arm II (Paclitaxel, Carboplatin) | 37.9 | 37.5 | 36.5 | 38.5 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | 6 Weeks | 15 Weeks | 26 Weeks |
---|
Doxorubicin, Cisplatin, Paclitaxel | 14.9 | 13.5 | 11.1 | 9.5 |
,Paclitaxel, Carboplatin | 14.9 | 11.3 | 11.2 | 10.9 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Pre-cycle 2 | Pre-cycle 5 | 9 months post cycle 1 |
---|
Arm I (Paclitaxel, Cisplatin) | 4.0 | 3.5 | 3.6 | 2.3 |
,Arm II (Vinorelbine, Cisplatin) | 3.9 | 3.5 | 4.0 | 3.2 |
,Arm III (Gemcitabine, Cisplatin) | 3.3 | 3.4 | 3.5 | 3.7 |
,Arm IV (Topotecan, Cisplatin) | 3.6 | 3.6 | 2.5 | 2.9 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Pre-cycle 2 | Pre-cycle 5 | 9 months post cycle 1 |
---|
Arm I (Paclitaxel, Cisplatin) | 14.4 | 14.1 | 13.1 | 11.1 |
,Arm II (Vinorelbine, Cisplatin) | 13.5 | 13.3 | 13.1 | 11.4 |
,Arm III (Gemcitabine, Cisplatin) | 14.2 | 13.7 | 14.1 | 12.3 |
,Arm IV (Topotecan, Cisplatin) | 14.1 | 14.2 | 14.4 | 13.1 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Pre-cycle 2 | Pre-cycle 5 | 9 months post cycle 1 |
---|
Arm I (Paclitaxel, Cisplatin) | 66.6 | 65.2 | 70.5 | 71.9 |
,Arm II (Vinorelbine, Cisplatin) | 69.1 | 65.5 | 66.6 | 69.9 |
,Arm III (Gemcitabine, Cisplatin) | 67.9 | 65.3 | 64.5 | 68.6 |
,Arm IV (Topotecan, Cisplatin) | 68.1 | 66.2 | 68.4 | 70.9 |
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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)
Intervention | months (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)
Intervention | months (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.
Intervention | Percentage of Participants (Number) |
---|
Cisplatin + Radiation, Then Surgery | 50 |
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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
Intervention | months (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
Intervention | months (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
Intervention | Percentage of Participants (Number) |
---|
| Complete Response (CR) | Partial Response (PR) |
---|
Group 1 (Platin Resistant) | 2.5 | 15 |
,Group 2 (Platin Sensitive) | 0 | 40 |
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Overall Survival
Overall Survival at six years after initiating protocol therapy (NCT00083551)
Timeframe: 6 Years
Intervention | percentage of participants (Number) |
---|
Thalidomide | 65 |
No Thalidomide | 58 |
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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.
Intervention | proportion of evaluable patients (Number) |
---|
Multi-agent Intrathecal and Systemic CT With RT (Modified IRS | 0.58 |
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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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | probability (Number) |
---|
Multi-agent Intrathecal and Systemic CT With RT (Modified IRS | 0.70 |
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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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse 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.
Intervention | adverse events (Number) |
---|
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 8 |
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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.
Intervention | adverse 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
Intervention | Participants (Count of Participants) |
---|
| Anemia or Febrile Neutropenia | Nausea or Vomiting | Infections and Infestations | Neutorphil or White blood count decrease | Hypokalemia or Hyponatremia |
---|
Regimen B (Chemotherapy Plus Radiotherapy) | 2 | 2 | 2 | 7 | 3 |
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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
Intervention | Scores on a scale (Mean) |
---|
| Overall IQ Score | Self Report Score-Internalizing Problems | Self Report Score-Emotional Problems | Self Report Score-Personal Adjustment Strengths | Parent Report QoL Total Score | Self Report QoL Total Score |
---|
Regimen A (Radiotherapy Only) | 98.60 | 41.00 | 44.00 | 51.50 | 88.04 | 95.65 |
,Regimen B (Chemotherapy Plus Radiotherapy) | 92.43 | 42.50 | 42.00 | 60.50 | 79.35 | 90.76 |
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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
Intervention | participants (Number) |
---|
| Experienced a qualifying event | Event-free through 3 years of follow-up | Event-free at data cutoff (if < 3 years follow-up) | Withdrew from study prior to 3 years of follow-up | Lost to follow-up prior to 3 years of follow-up |
---|
Regimen A (Radiotherapy Only) | 1 | 0 | 9 | 0 | 0 |
,Regimen B (Chemotherapy Plus Radiotherapy) | 1 | 0 | 11 | 0 | 0 |
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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
Intervention | Participants (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
Intervention | probability 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | T-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
Intervention | T-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
Intervention | T-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
Intervention | Percentage 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
Intervention | Percentage probability of PFS (Number) |
---|
Group 3 Medulloblastoma | 70.6 |
Group 4 Medulloblastoma | 90.6 |
Sonic Hedgehog (SHH) Medulloblastoma | 90.4 |
Wingless (WNT) Medulloblastoma | 98.4 |
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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
Intervention | Probability 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
Intervention | Probability 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
Intervention | probability 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
Intervention | Percentage of Participants (Number) |
---|
Eligible and Evaluable Patients | 32 |
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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
Intervention | Percentage of Participants (Number) |
---|
Eligible and Evaluable Patients | 69 |
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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
Intervention | Percentage 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
Intervention | Percentage 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
Intervention | percentage 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
Intervention | Percentage 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
Intervention | Percentage 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
Intervention | Percent probability of overall survival (Number) |
---|
Group 3 Medulloblastoma | 76.3 |
Group 4 Medulloblastoma | 97.3 |
Sonic Hedgehog (SHH) Medulloblastoma | 92.0 |
Wingless (WNT) Medulloblastoma | 98.3 |
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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
Intervention | uU/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
Intervention | Percentage of Participants (Number) |
---|
Eligible and Evaluable Patients | 58 |
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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
Intervention | proportion of participants (Number) |
---|
Cisplatin, C225, Radiation | 47 |
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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
Intervention | proportion of participants (Number) |
---|
Cisplatin, C225, Radiation | 66 |
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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
Intervention | proportion of participants (Number) |
---|
Cisplatin, C225, Radiation | 66.7 |
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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
Intervention | participants (Number) |
---|
Placebo | 42 |
Palifermin | 49 |
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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
Intervention | participants (Number) |
---|
Placebo | 11 |
Palifermin | 13 |
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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.
Intervention | units on a scale (Mean) |
---|
Placebo | 1.86 |
Palifermin | 1.66 |
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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
Intervention | days (Median) |
---|
Placebo | 35.0 |
Palifermin | 47.0 |
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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
Intervention | mg of IV morphine equivalents (Mean) |
---|
Placebo | 1219.55 |
Palifermin | 1243.31 |
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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
Intervention | participants (Number) |
---|
| Yes | No | Unknown |
---|
Palifermin | 51 | 43 | 0 |
,Placebo | 62 | 29 | 3 |
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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
Intervention | participants (Number) |
---|
| Yes | No | Unknown |
---|
Palifermin | 37 | 31 | 26 |
,Placebo | 57 | 19 | 18 |
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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
Intervention | days (Median) |
---|
Placebo | 26.0 |
Palifermin | 5.0 |
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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
Intervention | participants (Number) |
---|
| CR/PR | Histological response |
---|
Cisplatin Liposomal 24 mg/m2 | 2 | 1 |
,Cisplatin Liposomal 36 mg/m2 | 2 | 1 |
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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
Intervention | scores on a scale (Least Squares Mean) |
---|
| At baseline | At cycle 3 | Month 6 |
---|
Cetuximab Plus Chemotherapy | 50.74 | 52.68 | 55.30 |
,Chemotherapy Alone | 45.15 | 45.48 | 42.49 |
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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
Intervention | scores on a scale (Least Squares Mean) |
---|
| At baseline | At cycle 3 | Month 6 |
---|
Cetuximab Plus Chemotherapy | 62.14 | 64.64 | 61.27 |
,Chemotherapy Alone | 62.05 | 60.67 | 65.72 |
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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
Intervention | percentage of participants (Number) |
---|
Cetuximab Plus Chemotherapy | 35.6 |
Chemotherapy Alone | 19.5 |
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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
Intervention | percentage of participants (Number) |
---|
Cetuximab Plus Chemotherapy | 81.1 |
Chemotherapy Alone | 60.0 |
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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
Intervention | months (Median) |
---|
Cetuximab Plus Chemotherapy | 5.6 |
Chemotherapy Alone | 4.7 |
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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
Intervention | months (Median) |
---|
Cetuximab Plus Chemotherapy | 10.1 |
Chemotherapy Alone | 7.4 |
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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
Intervention | months (Median) |
---|
Cetuximab Plus Chemotherapy | 5.6 |
Chemotherapy Alone | 3.3 |
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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
Intervention | participants (Number) |
---|
Cetuximab Plus Chemotherapy | 218 |
Chemotherapy Alone | 208 |
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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
Intervention | months (Median) |
---|
Cetuximab Plus Chemotherapy | 4.8 |
Chemotherapy Alone | 3.0 |
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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.
Intervention | Percentage of participants (Number) |
---|
MAP-GR | 84 |
MAPifn | 84 |
MAP-PR | 68 |
MAPIE | 68 |
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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.
Intervention | Participants (Count of Participants) |
---|
MAP-GR | 348 |
MAPifn | 340 |
MAP-PR | 287 |
MAPIE | 281 |
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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.
Intervention | Percentage EFS (Number) |
---|
MAP-GR | 74 |
MAPifn | 77 |
MAP-PR | 55 |
MAPIE | 53 |
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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)
Intervention | months (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)
Intervention | participants (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)
Intervention | months (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)
Intervention | months (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)
Intervention | months (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
Intervention | percentage of participants (Number) |
---|
Cetuximab Plus Chemotherapy | 72.5 |
Chemotherapy Alone | 71.5 |
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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
Intervention | percentage of participants (Number) |
---|
Cetuximab Plus Chemotherapy | 36.4 |
Chemotherapy Alone | 29.2 |
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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.
Intervention | ug/mL (Mean) |
---|
Cetuximab Concentration at End of Infusion Week 1 | 223.1 |
Cetuximab Concentration Before Infusion Week 7 | 51.5 |
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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
Intervention | scores on a scale (Least Squares Mean) |
---|
| At baseline | At cycle 3 | At month 6 |
---|
Cetuximab Plus Chemotherapy | 66.17 | 58.05 | 67.36 |
,Chemotherapy Alone | 64.73 | 67.13 | 66.47 |
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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
Intervention | scores on a scale (Least Squares Mean) |
---|
| At baseline | At cycle 3 | At month 6 |
---|
Cetuximab Plus Chemotherapy | 45.72 | 48.33 | 54.71 |
,Chemotherapy Alone | 46.36 | 51.55 | 52.92 |
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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
Intervention | participants (Number) |
---|
Cetuximab Plus Chemotherapy | 545 |
Chemotherapy Alone | 549 |
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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
Intervention | months (Median) |
---|
Cetuximab Plus Chemotherapy | 4.8 |
Chemotherapy Alone | 4.8 |
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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
Intervention | months (Median) |
---|
Cetuximab Plus Chemotherapy | 11.3 |
Chemotherapy Alone | 10.1 |
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2-Year Survival
Percentage of participants alive at 2 years. (NCT00191139)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Gemcitabine | 40.6 |
Gemcitabine Plus Docetaxel | 55.7 |
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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
Intervention | participants (Number) |
---|
Gemcitabine | 24 |
Gemcitabine Plus Docetaxel | 27 |
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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)
Intervention | participants (Number) |
---|
| Improvement | Stable | Worse |
---|
Gemcitabine | 8 | 10 | 2 |
,Gemcitabine Plus Docetaxel | 5 | 9 | 8 |
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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
Intervention | days (Median) |
---|
Gemcitabine | 162.5 |
Gemcitabine Plus Docetaxel | 408.0 |
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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
Intervention | days (Median) |
---|
Gemcitabine | 492.5 |
Gemcitabine Plus Docetaxel | 899.0 |
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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
Intervention | Months (Median) |
---|
BAY 43-9006, Docetaxel, Cisplatin | 5.8 |
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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
Intervention | Proportion of patients (Number) |
---|
BAY 43-9006, Docetaxel, Cisplatin | 0.409 |
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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.
Intervention | Months (Median) |
---|
BAY 43-9006, Docetaxel, Cisplatin | 13.6 |
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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
Intervention | Participants (Number) |
---|
Pancreatic Adenocarcinoma Patients | 7 |
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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
Intervention | Months (Median) |
---|
Pancreatic Adenocarcinoma Patients | 11.5 |
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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
Intervention | Estimated probability (Number) |
---|
Stratum II | 0.87 |
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Protective Effects of Amifostine Assessed Primarily by Sialometry
Weight of stimulated saliva production in grams. (NCT00274937)
Timeframe: At study enrollment
Intervention | Grams of saliva (Mean) |
---|
| At study Enrollment | At end of consolidation |
---|
Stratum II | 4.97 | 3.39 |
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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
Intervention | Grams of saliva (Mean) |
---|
| At study Enrollment | At end of consolidation |
---|
Stratum II | 3.37 | 2.30 |
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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
Intervention | participants (Number) |
---|
All Patients | 1 |
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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
Intervention | Estimated probability five year EFS (Number) |
---|
Stratum 1 | 0.86 |
Stratum 2 | 0.53 |
Stratum 3 | 0.51 |
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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
Intervention | Participants (Count of Participants) |
---|
All Patients | 71 |
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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
Intervention | Participants (Count of Participants) |
---|
All Patients | 15 |
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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
Intervention | participants (Number) |
---|
| C229R mutation in p53 in Patients from Brazil | C229R mutation in Patients not from Brazil | E180K mutation in p53 in Patients from Brazil | E180K mutation in Patients not from Brazil | G245C mutation in p53 in Patients from Brazil | G245C mutation in Patients not from Brazil | I254T mutation in p53 in Patients from Brazil | I254T mutation in Patients not from Brazil | L265Q mutation in p53 in Patients from Brazil | L265Q mutation in Patients not from Brazil | P47S mutation in p53 in Patients from Brazil | P47S mutation in Patients not from Brazil | Q52fs mutation in p53 in Patients from Brazil | Q52fs mutation in Patients not from Brazil | R158L mutation in Patients from Brazil | R158L mutation in Patients not from Brazil | G245S mutation in Patients from Brazil | G245S mutation in Patients not from Brazil | R213P mutation in p53 in Patients from Brazil | R213P mutation in Patients not from Brazil | R248L mutation in Patients from Brazil | R248L mutation in Patients not from Brazil | R282W mutation in p53 in Patients from Brazil | R282W mutation in p53 in Patients not from Brazil | R283H mutation in p53 in Patients from Brazil | R283H mutation in p53 in Patients not from Brazil | R337H mutation in p53 in Patients from Brazil | R337H mutation in p53 in Patients not from Brazil | R342X mutation in p53 in Patients from Brazil | R342X mutation in p53 in Patients not from Brazil | T125T c375G>A muation in p53 in Pts from Brazil | T125T c375G>A mutation in p53 in pts not from Braz | T125T splice in DBD in pts from Brazil | T125T splice in DBD in pts not from Brazil | wild type p53 in Patients from Brazil | wild type p53 in Patients not from Brazil |
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All Patients | 0 | 2 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 31 | 20 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 16 |
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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.
Intervention | Participants (Count of Participants) |
---|
| children with ACT - wild type (beta)-catenin | A43 del33bp mutation of (beta)-catenin |
---|
All Patients | 51 | 1 |
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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
Intervention | participants (Number) |
---|
| Incidence of Abdominal Infection | Incidence of Abdominal Pain | Incidence of Acidosis | Activated Partial Thromboplastin Time Prolonged | Incidence of Adrenal Insufficiency | Incidence of Alanine Aminotransferase Increased | Incidence of Allergic Reaction | Incidence of Anemia | Incidence of Anorexia | Incidence of Aspartate Aminotransferase Increased | Incidence of Blood Bilirubin Increased | Incidence of Cardiac Disorders - Other, Specify | Incidence of Catheter Related Infection | Incidence of Colitis | Incidence of Confusion | Incidence of Dehydration | Incidence of Depressed Level of Consciousness | Incidence of Diarrhea | Incidence of Dyspnea | Incidence of Enterocolitis Infectious | Incidence of Esophagitis | Incidence of Febrile Neutropenia | Incidence of Fever | Incidence of Gastrointestinal Disorders - Other, S | Incidence of Generalized Muscle Weakness | Incidence of GGT Increased | Incidence of Hearing Impaired | Incidence of Heart Failure | Incidence of Hyperglycemia | Incidence of Hyperkalemia | Incidence of Hypertension | Incidence of Hypocalcemia | Incidence of Hypoglycemia | Incidence of Hypokalemia | Incidence of Hypomagnesemia | Incidence of Hyponatremia | Incidence of Hypophosphatemia | Incidence of Hypotension | Incidence of Hypoxia | Incidence of Infections and Infestations - Other, | Incidence of INR Increased | Incidence of Left Ventricular Systolic Dysfunction | Incidence of Lung Infection | Incidence of Lymphocyte Count Decreased | Toxicity Associated with Mitotane | Incidence of Mucositis Oral | Incidence of Nausea | Incidence of Neutrophil Count Decreased | Incidence of Obstruction Gastric | Incidence of Pain | Incidence of Peripheral Motor Neuropathy | Incidence of Peripheral Sensory Neuropathy | Incidence of Pharyngitis | Incidence of Platelet Count Decreased | Incidence of Pneumonitis | Incidence of Premature Menopause | Incidence of Rash Maculo-papular | Incidence of Sepsis | Incidence of Skin Infection | Incidence of Sore Throat | Incidence of Upper Respiratory Infection | Incidence of Urinary Tract Infection | Incidence of Vascular Access Complication | Incidence of Ventricular Arrhythmia | Incidence of Vomiting | Incidence of White Blood Cell Decreased | Incidence of Wound Infection |
---|
Stratum 3 | 1 | 2 | 1 | 1 | 5 | 2 | 1 | 22 | 7 | 2 | 1 | 2 | 3 | 1 | 1 | 3 | 1 | 1 | 2 | 1 | 2 | 16 | 1 | 2 | 1 | 1 | 6 | 1 | 3 | 3 | 1 | 3 | 1 | 9 | 2 | 7 | 4 | 2 | 3 | 7 | 1 | 2 | 1 | 2 | 4 | 6 | 5 | 20 | 1 | 1 | 1 | 1 | 1 | 20 | 3 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 1 | 5 | 16 | 1 |
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Survival Post Treatment
Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates (NCT00304278)
Timeframe: 22 months
Intervention | participants (Number) |
---|
RADPLAT and Tarceva | 12 |
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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
Intervention | proportion 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
Intervention | proportion 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
Intervention | proportion 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
Intervention | proportion 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
Intervention | proportion 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
Intervention | months (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
Intervention | months (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
Intervention | percentage of participants (Number) |
---|
Endometrial Cancer: IMRT | 88 |
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.
Intervention | percentage of participants (Number) |
---|
Endometrial Cancer: IMRT | 5 |
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.
Intervention | participants (Number) |
---|
Endometrial Cancer: IMRT | 1 |
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.
Intervention | percentage of participants (Number) |
---|
Endometrial Cancer: IMRT | 27.9 |
Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | 22.5 |
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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
Intervention | percentage of participants (Number) |
---|
Endometrial Cancer: IMRT | 88 |
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.
Intervention | percentage 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
Intervention | Months (Median) |
---|
Low Risk Patient Stratum | 46 |
High Risk Patient Stratum | 17 |
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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.
Intervention | Months (Median) |
---|
Low Risk Patient Stratum | 38 |
High Risk Patient Stratum | 15 |
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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
Intervention | Participants (Number) |
---|
| Acidosis (metabolic or respiratory) | Arthritis (non-septic) | Calcium, serum-low (hypocalcemia) | Carbon monoxide diffusion capacity (DL(co)) | Creatinine | Dehydration | Dyspnea (shortness of breath) | Esophagitis | FEV(1) | Febrile neutropenia | Glucose, serum-high (hyperglycemia) | Hemoglobin | Hemorrhage, Respiratory tract NOS | Hemorrhage, GI - Peritoneal cavity | Hemorrhage, pulmonary/upper respiratory - Lung | Hypotension | Hypoxia | INR (of prothrombin time) | Inf (clin/microbio) w/Gr 3-4 neuts - Nose | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | Leukocytes (total WBC) | Lymphopenia | Muscle weakness, not d/t neuropathy - body/general | Nausea | Neutrophils/granulocytes (ANC/AGC) | Pain - Chest wall | Pain - Chest/thorax NOS | Pain - Head/headache | Pain - Joint | Pain - Neck | Pain - Throat/pharynx/larynx | Platelets | Pneumonitis/pulmonary infiltrates | Potassium, serum-low (hypokalemia) | Pulmonary/Upper Respiratory-Other (Specify) | Rash/desquamation | Rash: dermatitis associated w/radiation | Sodium, serum-low (hyponatremia) | Weight loss |
---|
Concurrent Chemotherapy and Radiotherapy | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 1 | 3 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 6 | 2 | 1 | 2 | 10 | 1 | 1 | 1 | 0 | 1 | 1 | 2 | 1 | 3 | 0 | 1 | 1 | 1 | 0 |
,Consolidation Therapy With Docetaxel and Bevacizumab. | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 1 |
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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
Intervention | percentage of participants (Number) |
---|
Low Risk Patient Stratum | 64 |
High Risk Patient Stratum | 70 |
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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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (Count of Participants) |
---|
| Nutritional Disorders Induction Cycle I | No Nutritional Disorders Induction Cycle I | Nutritional Disorders Induction Cycle II | No Nutritional Disorders Induction Cycle II | Nutritional Disorders Induction Cycle III | No Nutritional Disorders Induction Cycle III | Nutritional Disorders Consolidation Cycle I | No Nutritional Disorders Consolidation Cycle I | Nutritional Disorders Consolidation Cycle II | No Nutritional Disorders Consolidation Cycle II | Nutritional Disorders Consolidation Cycle III | No Nutritional Disorders Consolidation Cycle III |
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Arm I (Patients Treated Without Methotrexate (MTX)) | 10 | 29 | 13 | 26 | 7 | 32 | 12 | 27 | 9 | 30 | 10 | 29 |
,Arm II (Patients Treated With MTX) | 17 | 21 | 13 | 25 | 12 | 26 | 8 | 30 | 5 | 33 | 5 | 33 |
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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
Intervention | Participants (Count of Participants) |
---|
| GI Tox Induction Cycle I | No GI Tox Induction Cycle I | GI Tox Induction Cycle II | No GI Tox Induction Cycle II | GI Tox Induction Cycle III | No GI Tox Induction Cycle III | GI Tox Consolidation Cycle I | No GI Tox Consolidation Cycle I | GI Tox Consolidation Cycle II | No GI Tox Consolidation Phase II | GI Tox Consolidation Cycle III | No GI Tox Consolidation Cycle III |
---|
Arm I (Patients Treated Without Methotrexate (MTX)) | 8 | 31 | 4 | 35 | 4 | 35 | 11 | 28 | 7 | 32 | 5 | 34 |
,Arm II (Patients Treated With MTX) | 12 | 26 | 10 | 28 | 8 | 30 | 14 | 24 | 10 | 28 | 6 | 32 |
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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
Intervention | percentage 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
Intervention | percentage 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
Intervention | Participants (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
Intervention | Participants (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.
Intervention | Days (Mean) |
---|
Placebo | 32 |
Palifermin | 13 |
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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
Intervention | Participants (Count of Participants) |
---|
Placebo | 0 |
Palifermin | 0 |
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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.
Intervention | Participants (Count of Participants) |
---|
Placebo | 8 |
Palifermin | 4 |
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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.
Intervention | days (Mean) |
---|
Placebo | 48 |
Palifermin | 41 |
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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
Intervention | Participants (Count of Participants) |
---|
Placebo | 2 |
Palifermin | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Placebo | 2 |
Palifermin | 0 |
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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
Intervention | percentage 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
Intervention | percentage 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
Intervention | months (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
Intervention | months (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
Intervention | percentage 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
Intervention | months (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
Intervention | percentage 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.
Intervention | percentage of participants (Number) |
---|
Gemcitabine + Cisplatin | 50 |
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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.
Intervention | participants (Number) |
---|
| CR | PR | PD | SD |
---|
Gemcitabine + Cisplatin | 2 | 8 | 4 | 6 |
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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
Intervention | score 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
Intervention | Score 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
Intervention | Percent 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
Intervention | Percent 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
Intervention | Percent 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
Intervention | percentage 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
Intervention | T-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
Intervention | Score 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
Intervention | Percent 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
Intervention | percentage 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
Intervention | T-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
Intervention | T-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
Intervention | Score 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
Intervention | T-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.
Intervention | probability (%) (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).
Intervention | months (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).
Intervention | participants (Number) |
---|
| Partial Response | Stable Disease | Progressive Disease |
---|
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) | 23 | 7 | 5 |
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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).
Intervention | months (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.
Intervention | Months (Median) |
---|
S-1/Cisplatin | 3.8 |
5-FU/Cisplatin | 3.8 |
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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.
Intervention | Months (Median) |
---|
S-1/Cisplatin | 4.8 |
5-FU/Cisplatin | 5.5 |
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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).
Intervention | Percentage of patients in each group (Number) |
---|
S-1/Cisplatin | 29.1 |
5-FU/Cisplatin | 31.9 |
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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).
Intervention | Months (Median) |
---|
S-1/Cisplatin | 6.5 |
5-FU/Cisplatin | 5.8 |
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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.
Intervention | percentage of participants (Number) |
---|
| One-year | Two-year |
---|
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | 93.2 | 74.7 |
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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).
Intervention | percentage of participants (Number) |
---|
| Concurrent component | Adjuvant component |
---|
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | 68.2 | 68.2 |
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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).
Intervention | percentage 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.
Intervention | percentage of participants (Number) |
---|
| One-year | Two-year |
---|
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | 90.9 | 74.7 |
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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.
Intervention | percentage of participants (Number) |
---|
| One-year | Two-year |
---|
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | 93.2 | 90.9 |
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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
Intervention | participants (Number) |
---|
| Complete Response | Partial Response |
---|
Arm I (Combination Chemotherapy + Sunitinib Maintenance) | 3 | 4 |
,Arm II (Combination Chemotherapy + Placebo Maintenance) | 0 | 5 |
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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
Intervention | months (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
Intervention | months (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
Intervention | mg/day (Number) |
---|
Cohort 1 | 25 |
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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
Intervention | days (Mean) |
---|
Cisplatin / Capecitabine | 132.92 |
Epirubicin / Cisplatin / Capecitabine | 126.64 |
Epirubicin / Oxaliplatin / Capecitabine | 123.50 |
Docetaxel / Cisplatin / Capecitabine | 138.16 |
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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
Intervention | months (Median) |
---|
Cisplatin / Capecitabine | 4.43 |
Epirubicin / Cisplatin / Capecitabine | 5.17 |
Epirubicin / Oxaliplatin / Capecitabine | 7.07 |
Docetaxel / Cisplatin / Capecitabine | 7.87 |
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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
Intervention | months (Median) |
---|
Cisplatin / Capecitabine | 10.23 |
Epirubicin / Cisplatin / Capecitabine | 8.87 |
Epirubicin / Oxaliplatin / Capecitabine | 13.87 |
Docetaxel / Cisplatin / Capecitabine | 12.43 |
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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
Intervention | days (Mean) |
---|
Cisplatin / Capecitabine | 308.92 |
Epirubicin / Cisplatin / Capecitabine | 154.09 |
Epirubicin / Oxaliplatin / Capecitabine | 203.06 |
Docetaxel / Cisplatin / Capecitabine | 205.52 |
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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
Intervention | percentage of participants (Number) |
---|
Cisplatin / Capecitabine | 43.3 |
Epirubicin / Cisplatin / Capecitabine | 40.7 |
Epirubicin / Oxaliplatin / Capecitabine | 69.6 |
Docetaxel / Cisplatin / Capecitabine | 59.6 |
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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
Intervention | Liter/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
Intervention | Liter/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
Intervention | L/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
Intervention | hr (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
Intervention | hr (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
Intervention | hr (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
Intervention | hr (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
Intervention | hr (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
Intervention | hr (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
Intervention | hr (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
Intervention | hr (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
Intervention | L/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
Intervention | L/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
Intervention | L/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
Intervention | L/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
Intervention | L/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
Intervention | Percentage 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)]
Intervention | mg 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
Intervention | ng/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
Intervention | ng/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
Intervention | ng/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
Intervention | ng/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
Intervention | ng/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
Intervention | ng/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
Intervention | ng/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
Intervention | ng/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
Intervention | ng*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
Intervention | ng*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
Intervention | nanogram*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
Intervention | ng*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
Intervention | ng*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
Intervention | ng*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
Intervention | ng*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
Intervention | ng*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
Intervention | Months (Median) |
---|
Chemotherapy Alone | NA |
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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
Intervention | Months (Median) |
---|
Chemotherapy Alone | 8.5 |
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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
Intervention | Months (Median) |
---|
Panitumumab Plus Chemotherapy | 6.9 |
Chemotherapy Alone | 5.5 |
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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
Intervention | Months (Median) |
---|
Chemotherapy Alone | 4.2 |
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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
Intervention | Percentage of Participants (Mean) |
---|
Chemotherapy Alone | 13.33 |
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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
Intervention | Percentage of Participants (Mean) |
---|
Panitumumab Plus Chemotherapy | 80.77 |
Chemotherapy Alone | 72.55 |
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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
Intervention | Percentage of Participants (Mean) |
---|
Chemotherapy Alone | 53.33 |
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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
Intervention | Weeks (Mean) |
---|
Panitumumab Plus Chemotherapy | 8.8 |
Chemotherapy Alone | 10.6 |
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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
Intervention | Months (Median) |
---|
Panitumumab Plus Chemotherapy | 8.0 |
Chemotherapy Alone | 5.1 |
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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
Intervention | Weeks (Mean) |
---|
Chemotherapy Alone | 10.6 |
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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
Intervention | Months (Median) |
---|
Panitumumab Plus Chemotherapy | 12.9 |
Chemotherapy Alone | 13.8 |
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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
Intervention | Percentage of Participants (Mean) |
---|
Panitumumab Plus Chemotherapy | 44.23 |
Chemotherapy Alone | 37.25 |
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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
Intervention | percentage of participants (Number) |
---|
Cisplatin and Cetuximab | 20.0 |
Cisplatin | 10.3 |
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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
Intervention | months (Median) |
---|
Cisplatin and Cetuximab | 12.9 |
Cisplatin | 9.4 |
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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
Intervention | months (Median) |
---|
Cisplatin and Cetuximab | 3.7 |
Cisplatin | 1.5 |
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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
Intervention | participants (Number) |
---|
Cisplatin and Cetuximab | 114 |
Cisplatin | 57 |
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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
Intervention | months (Median) |
---|
Cisplatin and Cetuximab | 1.4 |
Cisplatin | 1.3 |
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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.
Intervention | Participants (Count of Participants) |
---|
Treated Regimen I | 37 |
Treated Regimen II | 49 |
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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.
Intervention | Participants (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
Intervention | Participants (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.
Intervention | Participants (Count of Participants) |
---|
Prognostic Group 1 | 45 |
Prognostic Group 2 | 4 |
Prognostic Group 3 | 0 |
Prognostic Group 4 | 13 |
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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
Intervention | days (Geometric Mean) |
---|
Biochemotherapy With Temozolomide | 93.2 |
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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
Intervention | Percentage of Participants (Number) |
---|
| pT0N0 | pT1N0 |
---|
Neoadjuvant Chemotherapy With M-VAC + Avastin | 38 | 53 |
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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
Intervention | Percentage of Participants (Number) |
---|
Neoadjuvant Chemotherapy With M-VAC + Avastin | 63 |
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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
Intervention | units on a scale (Mean) |
---|
| Change from baseline to Cycle 1 | Change from baseline to Cycle 2 | Change from baseline to Cycle 3 | Change from baseline to Cycle 4 | Change from baseline to Cycle 5 | Change from baseline to Cycle 6 |
---|
Treatment | 0.15 | -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
Intervention | percentage of treated patients (Number) |
---|
Treatment | 19.15 |
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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
Intervention | Participants (Count of Participants) |
---|
Avastin | 2 |
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Number of Patients Able to Complete 6 Cycles of Treatment.
Completion of cycle 6 (NCT00511992)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
Avastin | 17 |
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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
Intervention | participants (Number) |
---|
Cisplatin + Ifosfamide + Paclitaxel | 3 |
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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
Intervention | percentage of paticipants (Mean) |
---|
Arm A, - Modified DCF | 63 |
ARM B - Parent DCF With G-CSF | 53 |
Arm C - Modified DCF+ Trastuzumab | 73 |
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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
Intervention | months (Median) |
---|
Arm A, - Modified DCF | 18.8 |
ARM B - Parent DCF With G-CSF | 12.6 |
Arm C - Modified DCF+ Trastuzumab | 24.9 |
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Complete Pathologic Response
Per pathology review post surgery (NCT00522795)
Timeframe: At Surgery approximately 4weeks after last treatment
Intervention | participants (Number) |
---|
PPX, Cisplatin, Radiation | 12 |
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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)
Intervention | months (Median) |
---|
Pemetrexed/Cisplatin/Radiation Phase 2 | 13.7 |
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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)
Intervention | percentage of participants (Number) |
---|
Pemetrexed/Cisplatin/Radiation Phase 2 | 79.0 |
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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)
Intervention | milligrams per square meter (mg/m^2) (Number) |
---|
| Concurrent Phase MTD: Pemetrexed | Concurrent Phase MTD: Cisplatin | Consolidation Phase MTD: Pemetrexed | Consolidation Phase MTD: Cisplatin |
---|
Pemetrexed/Cisplatin/Radiation Phase 1 | 500 | 20 | 500 | 75 |
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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)
Intervention | participants (Number) |
---|
| Local/Regional | Distant | Local + Distant | Unknown |
---|
Pemetrexed/Cisplatin/Radiation Phase 2 | 8 | 17 | 1 | 1 |
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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
Intervention | percentage of participants (Number) |
---|
| 1 Year | 2 Years | 3 Years |
---|
Pemetrexed/Cisplatin/Radiation Phase 2 | 48.7 | 30.8 | 20.2 |
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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
Intervention | percentage of participants (Number) |
---|
| 2 years | 3 years |
---|
Pemetrexed/Cisplatin/Radiation Phase 2 | 56.4 | 46.2 |
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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)
Intervention | percentage of participants (Number) |
---|
| Complete Response | Partial Response |
---|
Pemetrexed/Cisplatin/Radiation Phase 2 | 0 | 45.95 |
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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)
Intervention | participants (Number) |
---|
| Serious Adverse Events (SAEs) | Other Non-serious Adverse Events (AEs) |
---|
Pemetrexed/Cisplatin/Radiation Phase 1 | 5 | 10 |
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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)
Intervention | months (Median) |
---|
Pemetrexed/Cisplatin/Radiation Phase 2 | 11.8 |
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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
Intervention | Percentage of participants (Number) |
---|
All Registered Patients | 77.4 |
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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
Intervention | percentage of treated patients (Number) |
---|
Treatment | 63.64 |
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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
Intervention | percentage of treated patients (Number) |
---|
Treatment | 81.81 |
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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
Intervention | Proporation of Participants (Number) |
---|
Panitumumab Plus Radiotherapy | 0.722 |
Chemoradiotherapy | 0.767 |
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Overall Survival
Time from first dose date to death (NCT00547157)
Timeframe: maximum follow up time 46.2 months
Intervention | months (Median) |
---|
Panitumumab Plus Radiotherapy | 41.7 |
Chemoradiotherapy | NA |
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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
Intervention | Proportion of Participants (Number) |
---|
Panitumumab Plus Radiotherapy | 0.51 |
Chemoradiotherapy | 0.61 |
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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
Intervention | months (Median) |
---|
Panitumumab Plus Radiotherapy | 17.3 |
Chemoradiotherapy | NA |
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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
Intervention | months (Median) |
---|
Panitumumab Plus Radiotherapy | 25.1 |
Chemoradiotherapy | NA |
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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
Intervention | Proportion of Participants (Number) |
---|
Panitumumab Plus Radiotherapy | 0.144 |
Chemoradiotherapy | 0.117 |
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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
Intervention | percentage of participants (Number) |
---|
| Abdominal pain | Acute kidney injury | Alanine aminotransferase increased | Anemia | Anorexia | Apnea | Aspartate aminotransferase increased | Catheter related infection | Dehydration | Depressed level of consciousness | Diarrhea | Encephalopathy | Enterocolitis | Enterocolitis infectious | Esophagitis | Febrile neutropenia | Fever | GGT increased | Gastric hemorrhage | Hearing impaired | Hypermagnesemia | Hypertension | Hypoalbuminemia | Hypocalcemia | Hypoglycemia | Hypokalemia | Hypomagnesemia | Hyponatremia | Hypophosphatemia | Hypotension | Hypoxia | Infections and infestations - Other, specify | Lower gastrointestinal hemorrhage | Lung infection | Lymphocyte count decreased | Mucositis oral | Nausea | Nervous system disorders - Other, specify | Neutrophil count decreased | Oral pain | Pain | Peripheral motor neuropathy | Pharyngeal mucositis | Platelet count decreased | Pneumonitis | Rectal pain | Seizure | Sepsis | Sinus tachycardia | Sinusitis | Skin infection | Upper respiratory infection | Vomiting | White blood cell decreased |
---|
Stage 2/3 Patients | 0 | 0 | 0 | 0 | 11.1 | 0 | 0 | 11.1 | 0 | 0 | 5.6 | 0 | 0 | 5.6 | 0 | 55.6 | 11.1 | 0 | 0 | 11.1 | 5.6 | 0 | 0 | 5.6 | 0 | 27.8 | 5.6 | 11.1 | 22.2 | 0 | 0 | 27.8 | 0 | 16.7 | 0 | 5.6 | 16.7 | 0 | 5.6 | 0 | 0 | 5.6 | 0 | 5.6 | 5.6 | 0 | 0 | 0 | 0 | 11.1 | 0 | 11.1 | 11.1 | 5.6 |
,Stage 4a Patients | 5.6 | 5.6 | 16.7 | 0 | 33.3 | 0 | 11.1 | 0 | 11.1 | 0 | 16.7 | 0 | 5.6 | 11.1 | 5.6 | 55.6 | 0 | 5.6 | 5.6 | 5.6 | 0 | 5.6 | 0 | 5.6 | 0 | 16.7 | 5.6 | 0 | 0 | 11.1 | 2.6 | 33.3 | 5.6 | 0 | 0 | 27.8 | 11.1 | 0 | 0 | 5.6 | 5.6 | 0 | 5.6 | 0 | 0 | 5.6 | 0 | 11.1 | 5.6 | 0 | 5.6 | 5.6 | 22.2 | 0 |
,Stage 4b Patients | 0 | 0 | 5.3 | 5.3 | 15.8 | 5.3 | 5.3 | 0 | 10.5 | 5.3 | 0 | 5.3 | 0 | 5.3 | 0 | 36.8 | 5.3 | 0 | 0 | 5.3 | 0 | 0 | 5.3 | 10.5 | 5.3 | 21.1 | 10.5 | 15.8 | 10.5 | 0 | 0 | 21.1 | 0 | 0 | 5.3 | 5.3 | 5.3 | 10.5 | 5.3 | 0 | 0 | 0 | 0 | 5.3 | 0 | 0 | 5.3 | 0 | 0 | 0 | 5.3 | 0 | 5.3 | 5.3 |
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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
Intervention | percentage of participants (Number) |
---|
All Eligible Patients | 68 |
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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
Intervention | Probability (Number) |
---|
Stage 2/3 Patients | 88 |
Stage 4a Patients | 83 |
Stage 4b Patients | 28 |
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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
Intervention | percentage of patients (Number) |
---|
| Leukocytes | Rash | Colitis | Dehydration | Diarrhea | Vomiting | Hemorrhage, Upper Respiratory | Infection with normal ANC | Edema |
---|
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 9 | 9 | 9 | 18 | 9 | 9 | 9 | 9 | 9 |
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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
Intervention | patients (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
Intervention | Percentage 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
Intervention | Percentage of patients (Number) |
---|
Single HST (CEM) | 8.25 |
Tandem HST (CEM), Randomly Assigned | 9.66 |
Not Assigned | 7.78 |
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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
Intervention | percent 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
Intervention | Micromolar (Median) |
---|
Single HST (CEM) | 1.00 |
Tandem HST (CEM), Randomly Assigned | 1.36 |
Not Assigned | 1.26 |
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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
Intervention | percent probability (Number) |
---|
Single HST (CEM) | 48.8 |
Tandem HST (CEM), Randomly Assigned | 61.8 |
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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
Intervention | Proportion of patients (Number) |
---|
Single HST (CEM) | 0.96 |
Tandem HST (CEM), Randomly Assigned | 0.96 |
Not Assigned | 0.97 |
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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
Intervention | Proportion participants that responded (Number) |
---|
Single HST (CEM) | 0.54 |
Tandem HST (CEM), Randomly Assigned | 0.48 |
Not Assigned | 0.35 |
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Surgical Response
Percentage of patients who achieved a surgical complete resection (NCT00567567)
Timeframe: Up to 3 years
Intervention | Percentage of patients (Number) |
---|
Single HST (CEM) | 83.98 |
Tandem HST (CEM), Randomly Assigned | 84.09 |
Not Assigned | 58.89 |
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Topotecan Systemic Clearance
Median topotecan systemic clearance for courses 1 and 2. (NCT00567567)
Timeframe: Day 1 of courses 1-2
Intervention | L/h/m2 (Median) |
---|
Single HST (CEM) | 28.1 |
Tandem HST (CEM), Randomly Assigned | 28.1 |
Not Assigned | 28.5 |
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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
Intervention | Days (Median) |
---|
Single HST (CEM) | 7 |
Tandem HST (CEM), Randomly Assigned | 7 |
Not Assigned | 7 |
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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
Intervention | cells/mm^3 (Median) |
---|
| CD3 | CD4 | CD8 |
---|
Single HST (CEM) | 200 | 73 | 104 |
,Tandem HST (CEM), Randomly Assigned | 255.5 | 81 | 151 |
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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
Intervention | percent 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
Intervention | Percentage of patients (Number) |
---|
Single HST (CEM) | 13.11 |
Tandem HST (CEM), Randomly Assigned | 12.50 |
Not Assigned | 11.85 |
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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
Intervention | Days (Median) |
---|
Single HST (CEM) | 4 |
Tandem HST (CEM), Randomly Assigned | 4 |
Not Assigned | 4 |
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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
Intervention | percentage of patients (Number) |
---|
Group 1 | 12.5 |
Group 2 | 20.0 |
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Total Number of Days of Stem Cell Collection (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
Intervention | Days (Mean) |
---|
Usual Care | 5.3 |
Exercise | 4.0 |
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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
Intervention | g/dl (Mean) |
---|
| Baseline | Before Transplantation | During Transplanation | At Discharge |
---|
Exercise | 11.7 | 12.0 | 10.8 | 11.0 |
,Usual Care | 11.5 | 12.0 | 10.8 | 10.9 |
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Total Number of Days of Stem Cell Collection (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
Intervention | Days (Mean) |
---|
Usual Care | 4.9 |
Exercise | 4.5 |
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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
Intervention | Platelet transfusions (Mean) |
---|
Usual Care | 3.1 |
Exercise | 2.3 |
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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
Intervention | RBC Transfusions (Mean) |
---|
Usual Care | 1.8 |
Exercise | 1.0 |
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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
Intervention | RBC Transfusions (Mean) |
---|
Usual Care | 2.3 |
Exercise | 1.8 |
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Number of Stem Cell Collection Attempts (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
Intervention | Stem Cell Collection Attempts (Mean) |
---|
Usual Care | 1.3 |
Exercise | 1.1 |
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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
Intervention | Platelet Transfusions (Mean) |
---|
Usual Care | 3.6 |
Exercise | 2.0 |
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Number of Stem Cell Collection Attempts (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
Intervention | Stem Cell Collection Attempts (Mean) |
---|
Usual Care | 1.4 |
Exercise | 1.1 |
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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
Intervention | g/dl (Mean) |
---|
| Baseline | Before transplantation | During transplantation | At discharge |
---|
Exercise | 11.6 | 11.0 | 10.4 | 10.6 |
,Usual Care | 12.1 | 10.8 | 10.1 | 10.6 |
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Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
(NCT00582205)
Timeframe: 3 years
Intervention | Participants (Count of Participants) |
---|
Paclitaxel, Cisplatin IP | 7 |
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Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
(NCT00582205)
Timeframe: 3 years
Intervention | Participants (Count of Participants) |
---|
Paclitaxel, Cisplatin IP | 7 |
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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
Intervention | months (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
Intervention | months (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
Intervention | proportion 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
Intervention | participants (Number) |
---|
| Neutropenia | Anorexia | Diarrhea | Hypomagnesemia | Leukopenia | Lymphopenia | Dyspnea | Fatigue | Hemoglobin | Hematocrit | Hyperkalemia | Hypoglycemia | Hyponatremia | Infection without neutropenia | Platelets | Renal failure |
---|
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 3 | 1 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 1 | 1 | 1 | 0 | 3 | 3 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
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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
Intervention | participants (Number) |
---|
| Absolute neutrophil count | Anorexia | Anxiety | Diarrhea | Dyspnea | Dysuria | Fatigue | Granulocytes/bands | Hemoglobin | Hematocrit | Vaginal bleeding | Hyperglycemia | Hypermagnesemia | Hypertension | Hypocalcemia | Hypokalemia | Hyponatremia | Hypomagnesemia | Infection with neutropenia | Infection (Urinalysis) | Leukopenia | Lymphopenia | Nausea | Abdominal pain | Pelvic pain | Pain - not otherwise specified (NOS) | packed red blood cell (PRBC) Transfusion | Platelets | Proteinuria | Skin | Vomiting | Weight loss | Albumin | Atrial fibrillation | Confusion | Creatinine | Vaginal mucosa erythematous | Edema | erythrocyte sedimentation rate (ESR) | Hyperkalemia | Hypoglycemia | international normalized ratio (INR) | Leucocyte esterase | Prothrombin time (PT) | partial thromboplastin time (PTT) | Renal failure | aspartate aminotransferase (ALT) | Yeast infection |
---|
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 6 | 1 | 1 | 5 | 1 | 1 | 9 | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 3 | 5 | 3 | 1 | 1 | 1 | 10 | 35 | 4 | 3 | 2 | 4 | 5 | 2 | 1 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 4 | 1 | 0 | 5 | 1 | 0 | 4 | 2 | 6 | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 5 | 2 | 3 | 10 | 25 | 1 | 1 | 2 | 0 | 11 | 2 | 0 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 4 | 1 | 1 | 1 |
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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)
Intervention | participants (Number) |
---|
| Positive PET scan | Negative PET scan | Equivocal PET scan | PET scan not performed |
---|
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 6 | 27 | 6 | 2 |
,Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 9 | 7 | 4 | 0 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1968 |
Intermediate-Risk Group | 1504 |
High-Risk Group | 868 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 2.95 |
Intermediate-Risk Group | 2.83 |
High-Risk Group | 2.74 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1.59 |
Intermediate-Risk Group | 1.65 |
High-Risk Group | 1.41 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 140.2 |
Intermediate-Risk Group | 137.8 |
High-Risk Group | 135.3 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 132.7 |
Intermediate-Risk Group | 46.8 |
High-Risk Group | 44.0 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 128.9 |
Intermediate-Risk Group | 62.2 |
High-Risk Group | 51.8 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1.98 |
Intermediate-Risk Group | 1.96 |
High-Risk Group | 1.82 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 116.4 |
Intermediate-Risk Group | 111.3 |
High-Risk Group | 109.1 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 95.9 |
Intermediate-Risk Group | 49.5 |
High-Risk Group | 43.5 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 96.8 |
Intermediate-Risk Group | 48.7 |
High-Risk Group | 39.8 |
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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
Intervention | L/m^2 (Median) |
---|
Low-Risk Group | 12.64 |
Intermediate-Risk Group | 13.31 |
High-Risk Group | 13.68 |
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Pharmacogenetic Variation on Central Nervous System Transmitters
Frequencies of genetic polymorphisms were reported. (NCT00602667)
Timeframe: At study enrollment (Day 0)
Intervention | Participants (Count of Participants) |
---|
| Genetic Polymorphisms for monoamine oxidase A (MAOA) rs632372067969 | Genetic Polymorphisms for catecholamine-O-methyltransferase (COMT) rs468072067969 | Genetic Polymorphisms for dopamine receptor D (DRD3) rs628072067969 |
---|
| AG | CC | TC | TT | GG | AA | TG |
---|
Patients With Neurotransmitter Studies | 2 |
Patients With Neurotransmitter Studies | 13 |
Patients With Neurotransmitter Studies | 7 |
Patients With Neurotransmitter Studies | 5 |
Patients With Neurotransmitter Studies | 0 |
Patients With Neurotransmitter Studies | 6 |
Patients With Neurotransmitter Studies | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
| PTCH1 alteration | SUFU alteration | KMT2D alteration | SMO alteration | BCOR alteration | PTEN alteration | BRCA2 alteration | GLI2 alteration | SMARCA4 alteration | TP53 alteration | MYCN amplification | chr2p gain/amplification | chr2p loss/deletion | chr2q gain/amplification | chr2q loss/deletion | chr6p gain/amplification | chr6p loss/deletion | chr6q gain/amplification | chr6q loss/deletion | chr8p gain/amplification | chr8p loss/deletion | chr8q gain/amplification | chr8q loss/deletion | chr9p gain/amplification | chr9p loss/deletion | chr9q gain/amplification | chr9q loss/deletion | chr10p gain/amplification | chr10p loss/deletion | chr10q gain/amplification | chr10q loss/deletion | chr20p gain/amplification | chr20p loss/deletion | chr20q gain/amplification | chr20q loss/deletion |
---|
High-risk Group 3 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 3 | 2 | 3 | 2 | 0 | 7 | 0 | 6 | 0 | 3 | 0 | 3 | 0 | 7 | 0 | 8 | 0 | 4 | 0 | 4 |
,High-risk Group 4 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,High-risk SHH Patients | 3 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 |
,Intermediate-risk Group 3 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 2 | 0 | 1 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 5 | 0 | 5 | 0 | 3 | 0 | 3 |
,Intermediate-risk Group 4 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 4 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Intermediate-risk SHH Patients | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 5 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 |
,Low-risk SHH Patients | 7 | 6 | 5 | 2 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 5 | 0 | 5 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 4 | 4 | 2 | 6 | 0 | 0 | 0 | 3 | 0 | 2 | 0 | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
| PTCH1 alteration | SUFU alteration | KMT2D alteration | SMO alteration | BCOR alteration | PTEN alteration | BRCA2 alteration | GLI2 alteration | SMARCA4 alteration | TP53 alteration | MYCN alteration |
---|
High-Risk Group | 3 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,Intermediate-Risk Group | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
,Low-Risk Group | 7 | 6 | 5 | 2 | 1 | 1 | 0 | 0 | 2 | 0 | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
| Number with frozen tumor tissue | Number with fixed tumor tissue |
---|
High-Risk Group | 32 | 71 |
,Intermediate-Risk Group | 73 | 153 |
,Low-Risk Group | 27 | 54 |
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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
Intervention | Participants (Count of Participants) |
---|
| chr2p gain/amplification | chr2p loss/deletion | chr2q gain/amplification | chr2q loss/deletion | chr6p gain/amplification | chr6p loss/deletion | chr6q gain/amplification | chr6q loss/deletion | chr8p gain/amplification | chr8p loss/deletion | chr8q gain/amplification | chr8q loss/deletion | chr9p gain/amplification | chr9p loss/deletion | chr9q gain/amplification | chr9q loss/deletion | chr10p gain/amplification | chr10p loss/deletion | chr10q gain/amplification | chr10q loss/deletion | chr20p gain/amplification | chr20p loss/deletion | chr20q gain/amplification | chr20q loss/deletion |
---|
High-Risk Group | 6 | 0 | 6 | 0 | 3 | 2 | 3 | 2 | 0 | 8 | 0 | 7 | 3 | 3 | 1 | 5 | 0 | 7 | 0 | 9 | 0 | 5 | 0 | 5 |
,Intermediate-Risk Group | 1 | 2 | 1 | 2 | 3 | 0 | 3 | 0 | 2 | 6 | 3 | 5 | 6 | 0 | 1 | 5 | 0 | 5 | 0 | 7 | 0 | 4 | 0 | 3 |
,Low-Risk Group | 5 | 0 | 5 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 4 | 4 | 2 | 6 | 0 | 0 | 0 | 3 | 0 | 2 | 0 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| rs6323 | rs4680 | rs6280 |
---|
Number of Patients With Neurotransmitter Studies | 17 | 17 | 17 |
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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
Intervention | ng/ml (Median) |
---|
| Dopamine concentration at baseline | Dopamine concentration at completion of treatment | Dopamine concentration at 12 months off treatment | Dopamine concentration at 24 months off treatment | Dopamine concentration at 36 months off treatment | 3,4-dihydroxyphenylacetic acid concentration at baseline | 3,4-dihydroxyphenylacetic acid concentration at completion of treatment | 3,4-dihydroxyphenylacetic acid concentration at 12 months off treatment | 3,4-dihydroxyphenylacetic acid concentration at 24 months off treatment | 3,4-dihydroxyphenylacetic acid concentration at 36 months off treatment | Hydroxytryptamine concentration at baseline | Hydroxytryptamine concentration at completion of treatment | Hydroxytryptamine concentration at 12 months off treatment | Hydroxytryptamine concentration at 24 months off treatment | Hydroxytryptamine concentration at 36 months off treatment | Hydroxyindoleacetic acid concentration at baseline | Hydroxyindoleacetic acid concentration at completion of treatment | Hydroxyindoleacetic acid concentration at 12 months off treatment | Hydroxyindoleacetic acid concentration at 24 months off treatment | Hydroxyindoleacetic acid concentration at 36 months off treatment | Homovanillic acid concentration at baseline | Homovanillic acid concentration at completion of treatment | Homovanillic acid concentration at 12 months off treatment | Homovanillic acid concentration at 24 months off treatment | Homovanillic acid concentration at 36 months off treatment |
---|
Patients With Neurotransmitter Studies | 3.16 | 3.70 | 6.43 | 4.46 | 4.05 | 2.56 | 1.62 | 1.04 | 1.52 | 1.00 | 2.38 | 2.01 | 2.00 | 2.44 | 1.62 | 52.03 | 52.72 | 35.72 | 33.98 | 31.56 | 82.44 | 114.13 | 68.28 | 88.27 | 79.78 |
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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
Intervention | L/h/m^2 (Median) |
---|
Intermediate-Risk Group | 30.3 |
High-Risk Group | 26.40 |
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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
Intervention | µg·h/L (Median) |
---|
Low-Risk Group | 10.90 |
Intermediate-Risk Group | 11.60 |
High-Risk Group | 10.33 |
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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
Intervention | µg·h/L (Median) |
---|
Intermediate-Risk Group | 117 |
High-Risk Group | 116 |
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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
Intervention | L/h (Median) |
---|
Low-Risk Group | 41.4 |
Intermediate-Risk Group | 41.0 |
High-Risk Group | 44.6 |
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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
Intervention | Percentage of participants (Number) |
---|
Intermediate-risk Patients Who Received Focal Radiation | 13.2 |
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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
Intervention | percentage of participants (Number) |
---|
Intermediate-risk Patients Who Received Focal Radiation | 25.6 |
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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)
Intervention | Percentage of patients (Number) |
---|
Intermediate-Risk Group | 58.3 |
High-Risk Group | 21.1 |
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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
Intervention | Percent Probability (Number) |
---|
Low-risk SHH Patients | 73.9 |
Intermediate-risk SHH Patients | 50.0 |
High-risk SHH Patients | 54.5 |
Intermediate-risk Group 3 Patients | 30.8 |
High-risk Group 3 Patients | 9.1 |
Intermediate-risk Group 4 Patients | 62.5 |
High-risk Group 4 Patients | 50.0 |
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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
Intervention | Percent Probability (Number) |
---|
Low-Risk Group | 73.9 |
Intermediate-Risk Group | 46.9 |
High-Risk Group | 30.8 |
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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
Intervention | Percent Probability (Number) |
---|
Low-Risk Group | 73.9 |
Intermediate-Risk Group | 46.9 |
High-Risk Group | 30.8 |
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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
Intervention | mean activation value (MAV) (Mean) |
---|
Intermediate Risk Group | 60 |
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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)
Intervention | percentage of participants (Number) |
---|
High-Risk Group | 13.2 |
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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
Intervention | participants (Number) |
---|
Intermediate-Risk Group | 1 |
High-Risk Group | 20 |
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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
Intervention | participants (Number) |
---|
Intermediate-Risk Group | 0 |
High-Risk Group | 8 |
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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
Intervention | Percent probability (Number) |
---|
SJYC07 Low-risk Medulloblastoma Patients | 100 |
SJYC07 Intermediate-risk Medulloblastoma Patients | 84.4 |
SJYC07 High-risk Medulloblastoma Patients | 61.5 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 2.17 |
Intermediate-Risk Group | 1.81 |
High-Risk Group | 1.62 |
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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
Intervention | L/m^2 (Median) |
---|
Low-Risk Group | 12.70 |
Intermediate-Risk Group | 13.55 |
High-Risk Group | 13.87 |
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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
Intervention | L/m^2 (Median) |
---|
Low-Risk Group | 13.77 |
Intermediate-Risk Group | 13.73 |
High-Risk Group | 13.62 |
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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
Intervention | L/m^2 (Median) |
---|
Low-Risk Group | 11.63 |
Intermediate-Risk Group | 13.70 |
High-Risk Group | 13.25 |
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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
Intervention | µmol/L (Median) |
---|
Low-Risk Group | 0.64 |
Intermediate-Risk Group | 0.64 |
High-Risk Group | 0.55 |
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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
Intervention | µmol/L (Median) |
---|
Low-Risk Group | 0.65 |
Intermediate-Risk Group | 0.70 |
High-Risk Group | 0.58 |
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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
Intervention | µmol/L (Median) |
---|
Low-Risk Group | 0.75 |
Intermediate-Risk Group | 0.72 |
High-Risk Group | 0.69 |
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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
Intervention | µmol/L (Median) |
---|
Low-Risk Group | 0.49 |
Intermediate-Risk Group | 0.57 |
High-Risk Group | 0.61 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 5.75 |
Intermediate-Risk Group | 5.89 |
High-Risk Group | 5.79 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 5.68 |
Intermediate-Risk Group | 5.78 |
High-Risk Group | 5.81 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 5.47 |
Intermediate-Risk Group | 5.70 |
High-Risk Group | 5.70 |
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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)
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 5.69 |
Intermediate-Risk Group | 6.06 |
High-Risk Group | 5.65 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1804 |
Intermediate-Risk Group | 1841 |
High-Risk Group | 1886 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1872 |
Intermediate-Risk Group | 1879 |
High-Risk Group | 1831 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1900 |
Intermediate-Risk Group | 1902 |
High-Risk Group | 1879 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1797 |
Intermediate-Risk Group | 1813 |
High-Risk Group | 1821 |
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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)
Intervention | Percentage of scheduled doses received (Mean) |
---|
Low-Risk Group | 96 |
Intermediate-Risk Group | 91 |
High-Risk Group | 98 |
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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
Intervention | Percent probability (Number) |
---|
SJYC07 Low-risk Medulloblastoma Patients | 73.9 |
SJYC07 Intermediate-risk Medulloblastoma Patients | 46.9 |
SJYC07 High-risk Medulloblastoma Patients | 30.8 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 31.0 |
Intermediate-Risk Group | 23.5 |
High-Risk Group | 22.0 |
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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
Intervention | L/m^2 (Median) |
---|
Low-Risk Group | 72.9 |
Intermediate-Risk Group | 61.7 |
High-Risk Group | 104.8 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 6.53 |
Intermediate-Risk Group | 7.79 |
High-Risk Group | 8.40 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 2.40 |
Intermediate-Risk Group | 2.23 |
High-Risk Group | 2.25 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 2.48 |
Intermediate-Risk Group | 2.55 |
High-Risk Group | 2.37 |
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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
Intervention | L/h/m^2 (Median) |
---|
Low-Risk Group | 2.39 |
Intermediate-Risk Group | 2.08 |
High-Risk Group | 2.43 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 39.9 |
Intermediate-Risk Group | 38.7 |
High-Risk Group | 42.2 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 2070 |
Intermediate-Risk Group | 2150 |
High-Risk Group | 2105 |
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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
Intervention | µmol·h/L (Median) |
---|
Low-Risk Group | 1966 |
Intermediate-Risk Group | 799 |
High-Risk Group | 899 |
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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)
Intervention | participants (Number) |
---|
| Complete response | Partial response | Stable disease | Progressive disease |
---|
Cisplatin + Radiation + Recommended Surgery | 2 | 3 | 0 | 0 |
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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)
Intervention | participants (Number) |
---|
Cisplatin + Radiation + Recommended Surgery | 5 |
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Number of Participants With Surgical Complications
(NCT00603408)
Timeframe: 30 days post surgery (week 17-18)
Intervention | participants (Number) |
---|
Cisplatin + Radiation + Recommended Surgery | 0 |
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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)
Intervention | percentage of participants (Number) |
---|
Cisplatin + Radiation + Recommended Surgery | 100 |
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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
Intervention | participants (Number) |
---|
Placebo | 1 |
Palifermin | 0 |
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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)
Intervention | participants (Number) |
---|
| Any adverse event | Serious adverse event | Severe AE (Grade 3, 4 or 5) | Treatment related adverse event | Treatment related serious AE | Treatment related severe AE (Grade 3, 4 or 5) | Study Discontinuation Due to AE | Protocol Specific Limiting Toxicity (PSLT) | Deaths |
---|
Palifermin | 3 | 2 | 2 | 1 | 1 | 1 | 0 | 0 | 1 |
,Placebo | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Placebo | 2 |
Palifermin | 2 |
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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
Intervention | participants (Number) |
---|
| No. of patients with worst-grade toxicity of 1 | No. of patients with worst-grade toxicity of 2 | No. of patients with worst-grade toxicity of 3 | No. of patients with worst-grade toxicity of 4 | No. of patients with worst-grade toxicity of 5 |
---|
Therapeutic Intervention | 2 | 12 | 21 | 10 | 1 |
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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
Intervention | participants (Number) |
---|
| Partial Response | Progressive Disease | Stable Disease | Complete response |
---|
Therapeutic Intervention | 11 | 15 | 6 | 0 |
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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
Intervention | Estimated probability (Number) |
---|
Stratum I | 0.3401 |
Stratum III | 0.4500 |
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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
Intervention | Estimated Probability (Number) |
---|
Stratum I | 0.3888 |
Stratum III | 0.5486 |
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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.
Intervention | Participants (Count of Participants) |
---|
Stratum I | 3 |
Stratum III | 1 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Acidosis | Acute kidney injury | Apnea | Adult respiratory distress syndrome | Aspiration | Atelectasis | Catheter related infection | Central nervous system necrosis | Dehydration | Diarrhea | Dissmeminated intravascular coagulation (DIC) | Enterocolitis | Febrile neutropenia | Hearing impairment | Hematuria | Hydrocephalus | Hypernatremia | Hypoalbuminemia | Hypocalcemia | Hypoglycemia | Hypokalemia | Hyponatremia | Hypophosphatemia | Hypotension | Hypoxia | Increased Alanine aminotransferase | Increased Aspartate aminotransferase | Increased Lipase | Intracranial hemorrhage | ntraoperative venous injury | Laryngospasm | Left ventricular systolic dysfunction | Lung infection | Multi-organ failure | Mucositis oral | Poisoning and procedural complications | Other gastrointestinal disorders | Other infection | Pneumonitis | Productive cough | Pulmonary edema | Recurrent laryngeal nerve palsy | Renal calculi | Respiratory failure | Seizure | Sepsis | Sinus tachycardia | Stridor | Upper respiratory infection | Vascular access complication | Voice alteration | Vomiting | Weight loss |
---|
All Patients | 1 | 1 | 2 | 1 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 6 | 1 | 1 | 1 | 1 | 1 | 3 | 2 | 9 | 2 | 2 | 4 | 6 | 5 | 4 | 1 | 2 | 1 | 1 | 1 | 3 | 1 | 3 | 1 | 1 | 7 | 2 | 1 | 1 | 1 | 1 | 3 | 2 | 6 | 2 | 2 | 1 | 1 | 1 | 1 | 1 |
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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
Intervention | units on a scale (Mean) |
---|
Taxane Group: Multivitamin (MV) Arm | 13.0 |
Taxane Group: MV + Vitamin B12 + Vitamin B6 | 12.0 |
Heavy Metals Group: Multivitamin (MV) Arm | 9.7 |
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm | 8.4 |
Vinca Alkaloids Group: Multivitamin (MV) Arm | 14.56 |
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm | 5.6 |
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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
Intervention | units on a scale (Mean) |
---|
Taxane Group: Multivitamin (MV) Arm | 7.0 |
Taxane Group: MV + Vitamin B12 + Vitamin B6 | 7.2 |
Heavy Metals Group: Multivitamin (MV) Arm | 3.9 |
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm | 4.7 |
Vinca Alkaloids Group: Multivitamin (MV) Arm | 11.8 |
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm | 7 |
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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)
Intervention | units on a scale (Mean) |
---|
Taxane Group: Multivitamin (MV) Arm | 8.5 |
Taxane Group: MV + Vitamin B12 + Vitamin B6 | 7.3 |
Heavy Metals Group: Multivitamin (MV) Arm | 5.23 |
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm | 4.58 |
Vinca Alkaloids Group: Multivitamin (MV) Arm | 6.80 |
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm | 2.08 |
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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
Intervention | units on a scale (Mean) |
---|
Taxane Group: Multivitamin (MV) Arm | 14.5 |
Multivitamin + Vitamin B12 + Vitamin B6 | 14.5 |
Heavy Metals Group: Multivitamin (MV) Arm | 8.71 |
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm | 7.05 |
Vinca Alkaloids Group: Multivitamin (MV) Arm | 17.5 |
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm | 9.22 |
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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
Intervention | participants (Number) |
---|
| 4M PFS by Independent Image Review | 4M PFS by Site assess |
---|
Pemetrexed and Cisplatin | 9 | 13 |
,Pemetrexed, Cisplatin, and CBP501 | 25 | 27 |
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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
Intervention | mg/m2 (Number) |
---|
Receiving Treatment | 500 |
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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 Treatment | 80.0 |
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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
Intervention | ug/mL (Mean) |
---|
Pemetrexed Dose 500mg/m2 | 25.1 |
Pemetrexed Dose 750 mg/m2 | 39.3 |
Pemetrexed Dose 1,000mg/m2 | 38.7 |
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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 Treatment | 78.6 |
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Overall Survival
(NCT00702299)
Timeframe: Average Length of follow-up 788 days
Intervention | Days (Median) |
---|
Receiving Treatment | 680 |
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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
Intervention | participants (Number) |
---|
Receiving Treatment | 2 |
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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)
Intervention | participants (Number) |
---|
| Complete response | Partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 9 | 17 |
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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)
Intervention | percentage of participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease/Progressive Disease |
---|
Clinical Examination | 61 | 39 | 0 |
,CT Scan | 30 | 48 | 22 |
,FDG-PET/CT | 36 | 56 | 8 |
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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)
Intervention | percentage of participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease/Progressive Disease |
---|
Clinical Examination | 43 | 57 | 0 |
,CT Scan | 14 | 50 | 36 |
,FDG-PET/CT | 24 | 66 | 10 |
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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)
Intervention | participants (Number) |
---|
| Negative staining | 1+ staining (weak) | 2+ staining (moderate) | 3+ staining (strong) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 6 | 2 | 4 | 1 |
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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
Intervention | months (Mean) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 93.529 |
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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)
Intervention | percentage of participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease/Progressive Disease |
---|
Clinical Examination | 53 | 47 | 0 |
,CT Scan | 33 | 41 | 26 |
,FDG-PET/CT | 32 | 61 | 7 |
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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)
Intervention | participants (Number) |
---|
| Complete response | Partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 10 | 11 |
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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)
Intervention | participants (Number) |
---|
| Negative staining | 1+ staining (weak) | 2+ staining (moderate) | 3+ staining (strong) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 14 | 0 | 1 | 0 |
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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)
Intervention | participants (Number) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 14 |
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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)
Intervention | participants (Number) |
---|
| Overall complete response | Overall partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 4 | 14 |
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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)
Intervention | participants (Number) |
---|
| Negative staining | 1+ staining (0%-24%) | 2+ staining (25%-49%) | 3+ staining (50%-74%) | 4+ staining (75%-100%) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 14 | 0 | 1 | 0 | 0 |
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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)
Intervention | participants (Number) |
---|
| Complete response | Partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 7 | 12 |
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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)
Intervention | participants (Number) |
---|
| Negative staining | 1+ staining (0%-24%) | 2+ staining (25%-49%) | 3+ staining (50%-74%) | 4+ staining (75%-100%) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 6 | 4 | 1 | 2 | 0 |
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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)
Intervention | participants (Number) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 16 |
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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)
Intervention | participants (Number) |
---|
| Overall complete response | Overall partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 7 | 19 |
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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)
Intervention | participants (Number) |
---|
| Complete response | Partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 9 | 14 |
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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)
Intervention | participants (Number) |
---|
| Overall complete response | Overall partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 13 | 17 |
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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)
Intervention | participants (Number) |
---|
| Complete response | Partial response |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 11 | 7 |
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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
Intervention | participants (Number) |
---|
| Allergic reaction/hypersensitivity | Other allergic reaction:cipro | Other allergic reaction:hives | Hypotension | INR | Fatigue | Alopecia | Chelitis | Dry skin | Rash | Rash:acneiform | Rash:penile (unconfirmed HSV) | Anorexia | Colitis | Constipation | Dehydration | Dental:teeth | Diarrhea | Hemorrhoids | Nausea | Taste alteration | Vomiting | Other:soft stools | Hemoglobin | Leukocytes (WBC) | Lymphopenia | Neutrophils (ANC) | Platelets | Hemmorrhage:nose | Alkaline phosphatase | SGPT (ALT) | Infection other:sinus infection | Edema:limb | Albumin, low | Calcium, low | Magnesium, low | Potassium, low | Potassium, high | Sodium, low | Phosphorus | Dizziness | Mood alteration:anger | Neuropathy:sensory (peripheral) | Vision-photophobia | Pain:thigh | Pain:tumor pain | Hiccoughs (hiccups) | Obstruction/stenosis of airway:trachea | Creatinine | GFR | Renal failure | Thrombosis/thrombus/embolism |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 1 | 1 | 1 | 1 | 1 | 10 | 5 | 1 | 1 | 1 | 7 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | 1 | 8 | 8 | 8 | 8 | 2 | 1 | 3 | 2 | 1 | 2 | 1 | 5 | 4 | 3 | 2 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 4 | 2 | 1 | 1 |
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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
Intervention | months (Mean) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 38.675 |
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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
Intervention | months (Mean) |
---|
Induction Chemo + RT + Cisplatin or Cetuximab | 83.960 |
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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.
Intervention | participants (Number) |
---|
Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid | 1 |
Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid | 1 |
Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid | 3 |
Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD | 2 |
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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
Intervention | months (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
Intervention | months (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.
Intervention | Participants (Count of Participants) |
---|
| During Treatment | Between End of Treatment and 180 days after |
---|
5-FU and Cisplatin + BID Irradiation | 19 | 8 |
,Gemcitabine + QD Irradiation | 18 | 5 |
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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)
Intervention | Participants (Count of Participants) |
---|
5-FU and Cisplatin + BID Irradiation | 29 |
Gemcitabine + QD Irradiation | 25 |
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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.
Intervention | Participants (Count of Participants) |
---|
5-FU and Cisplatin + BID Irradiation | 4 |
Gemcitabine + QD Irradiation | 5 |
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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
Intervention | units on a scale (Median) |
---|
| Sensation of Not Emptying Bladder | Urinate Again < 2 Hours After Urinating | Stopped and Started When Urinating | Difficult to Postpone Urination | Weak Urinary Stream | Push or Strain to Begin Urination | How Often Get Up at Night to Urinate | AUA 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 Irradiation | 0.0 | -1.0 | 0.00 | -0.50 | 0.00 | 0.00 | -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.
Intervention | Participants (Count of Participants) |
---|
| Induction Therapy | Consolidation Therapy | Adjuvant Therapy |
---|
5-FU and Cisplatin + BID Irradiation | 32 | 27 | 18 |
,Gemcitabine + QD Irradiation | 31 | 23 | 17 |
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Probability of 2-year Overall Survival
(NCT00798655)
Timeframe: Up to 90 months for cohort; individual patients up to 24 months
Intervention | percentage of participants (Number) |
---|
Radiation Therapy+Cisplatin+Panitumumab | 72 |
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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
Intervention | percentage of participants (Number) |
---|
Radiation Therapy+Cisplatin+Panitumumab | 70 |
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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
Intervention | Participants (Count of Participants) |
---|
| Leukopenia | Thrombocytopenia | Neutropenia | Anemia | Other hematologic | Allergy/Immunology | Auditory/Ear | Cardiac | Coagulation | Constitutional | Dermatologic | Endocrine | Gastrointestinal | Genitourinary/Renal | Hemorrhage | Hepatobiliary | Infection | Lymphatics | Metabolic | Musculoskeletal | Neuropathy | Other Neurological | Pain | Pulmonary | Vascular | Death, Not CTC coded |
---|
Arm I (Paclitaxel and Cisplatin) | 34 | 6 | 48 | 33 | 3 | 4 | 1 | 2 | 4 | 12 | 0 | 2 | 22 | 10 | 4 | 0 | 17 | 3 | 18 | 0 | 9 | 8 | 21 | 3 | 8 | 1 |
,Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 48 | 5 | 61 | 29 | 8 | 4 | 1 | 16 | 4 | 16 | 0 | 0 | 29 | 8 | 7 | 0 | 18 | 1 | 23 | 2 | 12 | 5 | 30 | 9 | 17 | 2 |
,Arm III (Topotecan Hydrochloride and Paclitaxel) | 48 | 5 | 61 | 23 | 6 | 1 | 0 | 4 | 1 | 13 | 0 | 1 | 11 | 7 | 5 | 0 | 19 | 1 | 11 | 2 | 2 | 7 | 22 | 5 | 6 | 2 |
,Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 66 | 9 | 79 | 30 | 6 | 2 | 0 | 14 | 0 | 16 | 4 | 1 | 22 | 14 | 9 | 1 | 30 | 1 | 17 | 2 | 3 | 9 | 27 | 4 | 7 | 2 |
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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)
Intervention | months (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
Intervention | months (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.
Intervention | percentage 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.
Intervention | participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease | Disease Progression | Not Assessed |
---|
32mg/m^2+Cis 80mg/m^2 | 0 | 0 | 2 | 2 | 1 |
,Ixa 32 mg/m^2+Cis 60 mg/m^2 | 0 | 8 | 10 | 5 | 1 |
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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.
Intervention | participants (Number) |
---|
| Death | SAEs | Drug-Related SAEs | AEs Leading to Discontinuation | Drug-Related AEs Leading to Discontinuation | Overall AEs | Grade 3/4 AEs | Drug-Related AEs | Grade 3/4 Drug-Related AEs |
---|
32mg/m^2+Cis 80mg/m^2 | 1 | 2 | 1 | 0 | 0 | 5 | 3 | 5 | 3 |
,Ixa 32 mg/m^2+Cis 60 mg/m^2 | 4 | 7 | 4 | 2 | 1 | 24 | 14 | 24 | 11 |
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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
Intervention | participants (Number) |
---|
Ixa 32 mg/m^2+Cis 60 mg/m^2 | 0 |
32mg/m^2+Cis 80mg/m^2 | 2 |
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Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2
The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level. (NCT00832117)
Timeframe: Within the first 21 days of first cycle
Intervention | mg/m^2 (Number) |
---|
All Treated Participants | 60 |
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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.
Intervention | participants (Number) |
---|
| WBC, Grade 1-4 | WBC, Grade 3-4 | ANC, Grade 1-4 | ANC, Grade 3-4 | Platelet Count, Grade 1-4 | Platelet Count, Grade 3-4 | Hemoglobin, Grade 1-4 | Hemoglobin, Grade 3-4 |
---|
32mg/m^2+Cis 80mg/m^2 | 5 | 3 | 5 | 4 | 3 | 1 | 5 | 0 |
,Ixa 32 mg/m^2+Cis 60 mg/m^2 | 19 | 6 | 18 | 12 | 9 | 0 | 22 | 1 |
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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)
Intervention | months (Median) |
---|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 6.2 |
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 5.6 |
Randomized Part: Cetuximab + Chemotherapy | 5.0 |
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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)
Intervention | months (Median) |
---|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 13.6 |
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 13.6 |
Randomized Part: Cetuximab + Chemotherapy | 9.7 |
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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)
Intervention | percentage of participants (Number) |
---|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 37.6 |
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 27.5 |
Randomized Part: Cetuximab + Chemotherapy | 29.8 |
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Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)
(NCT00842712)
Timeframe: Up to Week 3
Intervention | participants (Number) |
---|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | 0 |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | 0 |
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | 0 |
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin | 0 |
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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)
Intervention | months (Median) |
---|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 4.4 |
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 2.8 |
Randomized Part: Cetuximab + Chemotherapy | 4.2 |
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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)
Intervention | months (Median) |
---|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 5.6 |
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 5.6 |
Randomized Part: Cetuximab + Chemotherapy | 5.3 |
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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
Intervention | Participants (Count of Participants) |
---|
| Dose 70 mg | Dose 100mg | Dose 150mg |
---|
Cohort A | 4 | 3 | 0 |
,Cohort B | 7 | 3 | 2 |
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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
Intervention | months (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
Intervention | months (Median) |
---|
High CTC Count | 4.1 |
Low CTC Count | 4.5 |
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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
Intervention | Proportion 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
Intervention | months (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.
Intervention | proportion 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.
Intervention | months (Median) |
---|
Arm A: PCA | 7.9 |
Arm B: TPCA | 8.4 |
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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..
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Removed Before Restaging |
---|
Arm A: PCA | 3 | 22 | 15 | 1 | 3 |
,Arm B: TPCA | 0 | 21 | 14 | 0 | 6 |
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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.
Intervention | months (Median) |
---|
Arm A: PCA | 11.7 |
Arm B: TPCA | 13.4 |
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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.
Intervention | probability (Number) |
---|
Arm A: PCA | 0.581 |
Arm B: TPCA | 0.582 |
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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
Intervention | months (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
Intervention | Participants (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
Intervention | proportion 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
Intervention | months (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
Intervention | unit on a scale (Least Squares Mean) |
---|
| Baseline | 6 weeks | 18 weeks | 70 weeks |
---|
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 14.9 | 14.4 | 10.4 | 11.8 |
,Arm II (Paclitaxel and Carboplatin) | 15.0 | 12.4 | 9.9 | 11.6 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | 6 weeks | 18 weeks | 70 weeks |
---|
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 98.4 | 89.5 | 87.8 | 96.0 |
,Arm II (Paclitaxel and Carboplatin) | 97.6 | 90.9 | 93.0 | 99.4 |
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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
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
---|
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 5 | 139 | 154 | 48 | 0 |
,Arm II (Paclitaxel and Carboplatin) | 15 | 118 | 119 | 105 | 3 |
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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
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
---|
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 85 | 71 | 45 | 14 | 1 |
,Arm II (Paclitaxel and Carboplatin) | 96 | 79 | 33 | 7 | 4 |
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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.
Intervention | participants (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
Intervention | days (Median) |
---|
A CBP501 +Cisplatin + Pemetrexed | 140 |
B Cisplatin + Pemetrexed | 165 |
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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
Intervention | Units on a scale (Least Squares Mean) |
---|
| Baseline | Prior to cycle 4 | Prior to cycle 7 | Prior to cycle 13 | Prior to cycle 21 | 84 weeks |
---|
Arm I (Paclitaxel, Carboplatin, Bevacizumab) | 15.4 | 12.9 | 10.4 | 11.1 | 11.4 | 11.9 |
,Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | 15.4 | 13.0 | 10.3 | 10.5 | 11.1 | 11.4 |
,Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) | 15.4 | 13.6 | 10.9 | 9.2 | 11.0 | 11.5 |
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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
Intervention | Participants (Count of Participants) |
---|
| Adverse Event Grade 0 | Adverse Event Grade 1 | Adverse Event Grade 2 | Adverse Event Grade 3 | Adverse Event Grade 4 | Adverse Event Grade 5 |
---|
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 0 | 1 | 48 | 269 | 185 | 8 |
,Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 0 | 0 | 46 | 300 | 158 | 6 |
,Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 1 | 0 | 52 | 246 | 199 | 10 |
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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
Intervention | Units on a scale (Least Squares Mean) |
---|
| Baseline | Prior to cycle 4 | Prior to cycle 7 | Prior to cycle 13 | Prior to cycle 21 | 84 weeks |
---|
Arm I (Paclitaxel, Carboplatin, Bevacizumab) | 68.5 | 67.8 | 69.1 | 77.3 | 77.7 | 78.3 |
,Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | 67.4 | 65.6 | 68.2 | 77.1 | 76.9 | 77.7 |
,Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) | 67.7 | 61.9 | 65.7 | 78.4 | 78.2 | 79.4 |
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Overall Survival
Estimate the median duration of overall survival in months. (NCT00951496)
Timeframe: Up to 10 years
Intervention | Months (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
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | Prior to cycle 4 | Prior to cycle 7 | Prior to cycle 13 | Prior to cycle 21 | 84 weeks |
---|
Arm I (Paclitaxel, Carboplatin, Bevacizumab) | 35.3 | 32.5 | 32.7 | 35.7 | 35.5 | 35.7 |
,Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | 35.1 | 32.0 | 32.7 | 35.5 | 35.1 | 36.0 |
,Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) | 35.3 | 31.3 | 32.4 | 35.9 | 36.3 | 36.5 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
| Baseline | Prior to cycle 4 | Prior to cycle 7 | Prior to cycle 13 | Prior to cycle 21 | 84 Weeks |
---|
Arm I (Paclitaxel, Carboplatin, Bevacizumab) | 0.4 | 0.6 | 0.5 | 0.2 | 0.3 | 0.3 |
,Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | 0.4 | 0.7 | 0.5 | 0.3 | 0.4 | 0.4 |
,Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) | 0.4 | 1.1 | 0.7 | 0.2 | 0.3 | 0.3 |
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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
Intervention | percentage 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
Intervention | SULmax (Mean) |
---|
Responders | -1.8 |
Non-Responders | 1.2 |
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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
Intervention | SULmax (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
Intervention | SULmax (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
Intervention | SULmax (Mean) |
---|
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery) | -3.8 |
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Overall Survival
(NCT00968799)
Timeframe: 5 years
Intervention | months (Median) |
---|
HIPEC | 26 |
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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
Intervention | participants (Number) |
---|
HIPEC | 4 |
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Nephrotoxicity
glomerular filtration rate (GFR) (NCT00968799)
Timeframe: 6 weeks post operation
Intervention | participants (Number) |
---|
| no nephrotoxicity (normal GFR) | CTCAE grade 1 nephrotoxicity (by GFR) |
---|
HIPEC | 2 | 2 |
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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
Intervention | participants (Number) |
---|
HIPEC | 0 |
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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)
Intervention | participants (Number) |
---|
| Adverse Events | Serious Adverse Events |
---|
Cisplatin or Carboplatin + Etoposide | 4 | 2 |
,Figitumumab + Cisplatin or Carboplatin + Etoposide | 5 | 4 |
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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
Intervention | Percent Probability (Number) |
---|
Very Low-risk Group | 100 |
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
Intervention | Cycles (Number) |
---|
| Hearing impaired | Diarrhea | Enterocolitis | Nausea | Small intestinal obstruction | Vomiting | Abdominal distension | Abdominal pain | Colitis | Anal mucositis | Ascites | Malabsorption | Mucositis oral | Constipation | Dental caries | Typhlitis | Duodenal obstruction | Esophageal hemorrhage | Gastritis | Illeus | Oral pain | Small intestinal mucositis | Colonic hemorrhage | Dysphagia | Esophagitis | Gastroparesis | Gastric fistula | Gastrointestinal disorders - Other, specify | Obstruction gastric | Rectal mucositis | Fever | General disorders and administration site conditions - Other, specify | Pain | Multi-organ failure | Irritability | Infusion related reaction | Hypothermia | Catheter related infection | Infections and infestations - Other, specify | Mucosal infection | Otitis media | Urinary tract infection | Biliary tract infection | Abdominal infection | Bladder infection | Enterocolitis infectious | Duodenal infection | Upper respiratory infection | Eye infection | Wound infection | Sepsis | Lung infection | Peritoneal infection | Skin infection | Small intestine infection | Periorbital infection | Alanine aminotransferase increased | Aspartate aminotransferase increased | Activated partial thromboplastin time prolonged | Alkaline phosphatase increased | Blood bilirubin increased | Creatinine increased | GGT increased | Weight loss | Fibronogen decreased | Ejection fraction decreased | Investigations - Other, specify | White blood cell decreased | INR increased | CPK increased | Cholesterol high | Electrocardiogram QT corrected interval prolonged | Lipase increased | Serum amylase increased | Anorexia | Dehydration | Hyperglycemia | Hyperkalemia | Hypermagnesemia | Hypernatremia | Hypokalemia | Hyponatremia | Acidosis | Alkalosis | Hypocalcemia | Hypoalbuminemia | Hypomagnesemia | Hypophosphatemia | Tumor lysis syndrome | Hypercalcemia | Hypoglycemia | Hypertriglyceridemia | Metabolism and nutrition disorders - Other, specify | Peripheral sensory neuropathy | Oculomotor nerve disorder | Abducens nerve disorder | Peripheral motor neuropathy | Syncope | Dysphasia | Depressed level of consciousness | Seizure | Apnea | Atelectasis | Dyspnea | Bronchospasm | Hypoxia | Pleural effusion | Pulmonary edema | Stridor | Respiratory failure | Epistaxis | Wheezing | Hypertension | Hematoma | Hypotension | Vascular disorders - Other, specify | Thromboembolic event | Left ventricular systolic dysfunction | Cardiac arrest | Right ventricular dysfunction | Ventricular tachycardia | Cardiac disorders - Other, specify | Sinus tachycardia | Heart failure | Myocardial infarction | Biliary fistula | Hepatobiliary disorders - Other, specify | Hepatic hemorrhage | Portal vein thrombosis | Portal hypertension | Biliary anastomotic leak | Postoperative hemorrhage | Gastrointestinal anastomotic leak | Intraoperative hemorrhage | Arthralgia | Generalized muscle weakness | Back pain | Bone pain | Muscle weakness lower limb | Agitation | Hallucinations | Insomnia | Acute kidney injury | Renal and urinary disorders - Other, specify | Renal calculi | Proteinuria | Erythema multiforme | Skin and subcutaneous tissue disorders - Other, specify | Rash maculo-papular | Eye disorders - Other, specify | Surgical and medical procedures - Other, specify | Tumor pain | Allergic reaction | Anaphylaxis | Immune system disorders - Other, specify |
---|
High-risk Group (Regimen H) | 4 | 15 | 1 | 3 | 0 | 5 | 0 | 6 | 1 | 0 | 0 | 0 | 6 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 9 | 0 | 4 | 2 | 1 | 1 | 1 | 0 | 9 | 0 | 0 | 3 | 0 | 0 | 0 | 5 | 0 | 2 | 0 | 0 | 3 | 1 | 0 | 7 | 0 | 1 | 6 | 19 | 1 | 1 | 5 | 1 | 6 | 6 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 17 | 12 | 10 | 5 | 0 | 3 | 29 | 10 | 1 | 3 | 2 | 1 | 2 | 19 | 0 | 0 | 1 | 4 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 0 | 6 | 1 | 0 | 0 | 1 | 1 | 1 | 4 | 0 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 2 | 2 | 1 |
,High-risk Group (Regimen W) | 4 | 15 | 0 | 10 | 0 | 13 | 3 | 9 | 1 | 0 | 0 | 0 | 8 | 1 | 0 | 2 | 0 | 0 | 1 | 4 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 27 | 1 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 9 | 10 | 3 | 0 | 2 | 0 | 1 | 4 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 20 | 3 | 5 | 3 | 0 | 0 | 12 | 6 | 0 | 0 | 4 | 3 | 3 | 7 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 2 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 2 | 0 | 0 | 0 | 2 | 0 | 2 | 1 | 3 | 1 | 1 | 1 | 3 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Intermediate-risk Group (Regimen F) | 20 | 15 | 0 | 10 | 1 | 24 | 1 | 10 | 3 | 1 | 1 | 1 | 44 | 2 | 1 | 2 | 1 | 1 | 1 | 3 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 1 | 6 | 1 | 0 | 0 | 0 | 8 | 38 | 0 | 0 | 3 | 1 | 1 | 2 | 8 | 1 | 4 | 1 | 1 | 5 | 2 | 1 | 1 | 1 | 0 | 28 | 37 | 2 | 1 | 7 | 3 | 7 | 6 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 30 | 13 | 15 | 12 | 4 | 1 | 48 | 22 | 4 | 1 | 7 | 3 | 11 | 21 | 2 | 0 | 0 | 0 | 0 | 5 | 3 | 1 | 7 | 1 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 10 | 2 | 1 | 1 | 2 | 0 | 0 | 6 | 1 | 3 | 2 | 0 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 2 | 1 | 1 | 1 | 4 | 1 | 0 | 9 | 3 | 1 | 0 | 1 | 2 | 3 | 1 | 1 | 0 | 0 | 0 | 0 |
,Low-risk Group (Regimen T) | 1 | 4 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 2 | 2 | 2 | 2 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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
Intervention | participants (Number) |
---|
| RECIST PR, no AFP response | AFP response, no RECIST response | RECIST response, AFP response | no AFP response, no RECIST response |
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High-risk Group (Regimen H) | 3 | 10 | 4 | 18 |
,High-risk Group (Regimen W) | 3 | 5 | 6 | 16 |
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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
Intervention | Participants (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
Intervention | Participants (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
Intervention | percentage of participants (Number) |
---|
Biweekly Schedule of Docetaxel and Cisplatin | 64.6 |
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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
Intervention | months (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
Intervention | months (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
Intervention | months (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
Intervention | months (Median) |
---|
Arm A (Sorafenib and TACE) | 8.5 |
Arm B (Placebo and TACE) | 7.8 |
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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
Intervention | percentage of participants (Number) |
---|
Chemoradiation (IMRT), Chemotherapy | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Chemoradiation (IMRT), Chemotherapy | 96.7 |
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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
Intervention | percentage of participants (Median) |
---|
Chemoradiation (IMRT), Chemotherapy | 17.0 |
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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
Intervention | percentage of participants (Number) |
---|
Chemoradiation (IMRT), Chemotherapy | 79.1 |
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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
Intervention | mg (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
Intervention | months (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.
Intervention | Participants (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.
Intervention | months (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.
Intervention | proportion 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)
Intervention | Participants (Number) |
---|
Part 1: MK-1775 65 mg BID | 0 |
Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg | 1 |
Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg | 1 |
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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
Intervention | Months (Median) |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA |
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA |
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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
Intervention | Months (Median) |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 14.36 |
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 6.14 |
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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
Intervention | Months (Median) |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 16.36 |
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 10.12 |
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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.
Intervention | Participants (Count of Participants) |
---|
Cohort 1, Arm 2 | 0 |
Cohort 2a, Arm 2 | 2 |
Cohort 2b, Arm 2 | 1 |
Cohort 3b, Arm 2 | 2 |
Cohort 4, Arm 2 | 0 |
MTD Confirmation Cohort, Arm 2 | 3 |
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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.
Intervention | Participants (Count of Participants) |
---|
Cohort 1, Arm 1 | 0 |
Cohort 2, Arm 1 | 0 |
Cohort 3, Arm 1 | 1 |
Cohort 4, Arm 1 | 2 |
MTD Confirmation Cohort, Arm 1 | 2 |
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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.
Intervention | Percentage of participants (Number) |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 81.3 |
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 51.9 |
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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.
Intervention | Percentage of Participants (Number) |
---|
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 21.3 |
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 36.4 |
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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.
Intervention | Percentage of Participants (Number) |
---|
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 91.7 |
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 96.4 |
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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.
Intervention | Percentage of participants (Number) |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 81.3 |
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 53.6 |
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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
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 80.00 | 66.67 | 22.22 |
,DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 60.98 | 47.92 | 33.54 |
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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
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 61.85 | 51.54 | 44.67 |
,MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 54.74 | 24.88 | NA |
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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
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 100.00 | 80.00 | 80.00 |
,DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 74.07 | 62.96 | 55.09 |
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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
Intervention | Months (Median) |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA |
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA |
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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.
Intervention | Percentage of Participants (Number) |
---|
| Subjects with AEs | Subjects with SAEs | Subjects with Grade 3 or 4 AEs | Subjects with Grade 5 AEs | Subjects discontinued due to AEs | Subjects with dose reduced due to AEs | Subjects with temporary discontinuation due to AEs |
---|
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 100 | 31.3 | 89.6 | 4.2 | 27.1 | 16.7 | 54.2 |
,Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 100 | 45.5 | 96.4 | 5.5 | 36.4 | 32.7 | 67.3 |
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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.
Intervention | ng/mL (Mean) |
---|
| Cycle 1 Day 2, 0h | Cycle 3 Day 2, 0h | Cycle 3 Day 2, 1h | Cycle 3 Day 2, 3h | Cycle 3 Day 3, 24h | Cycle 3 Day 8, 168h |
---|
Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA | 25.00 | 283.27 | 280.33 | 154.25 | NA |
,Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA | NA | 189.74 | 213.95 | 110.39 | NA |
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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.
Intervention | ng/mL (Mean) |
---|
| Cycle 1 Day 2, 0h |
---|
Cohort 1, Arm 2 | NA |
,Cohort 3b, Arm 2 | NA |
,Cohort 4, Arm 1 | NA |
,Cohort 4, Arm 2 | NA |
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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
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 84.38 | 78.13 | 71.61 |
,MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 88.00 | 59.11 | 53.74 |
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Disease Control (CR + PR + Stable Disease [SD])
Complete Response (CR) + Partial Response (PR) + Stable disease (NCT01064479)
Timeframe: 5 years
Intervention | Participants (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
Intervention | months (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
Intervention | months (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
Intervention | Participants (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
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response | Progressive Disease | Stable Disease | Inevaluable |
---|
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 4 | 27 | 8 | 16 | 5 |
,Arm B (Combination Chemotherapy and Placebo) | 5 | 19 | 13 | 17 | 5 |
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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.
Intervention | percentage of analyzed participants (Number) |
---|
Phase II Cisplatin-pemetrexed Cediranib 20mg | 75 |
Phase II Cisplatin-pemetrexed Placebo | 83 |
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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.
Intervention | percentage of analyzed participants (Number) |
---|
Phase II Cisplatin-pemetrexed Cediranib 20mg | 74 |
Phase II Cisplatin-pemetrexed Placebo | 80 |
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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.
Intervention | mg (Number) |
---|
All Phase I Participants | 20 |
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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.
Intervention | month (Median) |
---|
Phase II Cisplatin-pemetrexed Cediranib 20mg | 7.2 |
Phase II Cisplatin-pemetrexed Placebo | 5.6 |
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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.
Intervention | percentage of analyzed participants (Number) |
---|
Phase II Cisplatin-pemetrexed Cediranib 20mg | 50 |
Phase II Cisplatin-pemetrexed Placebo | 20 |
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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.
Intervention | percentage of analyzed participants (Number) |
---|
Phase II Cisplatin-pemetrexed Cediranib 20mg | 26 |
Phase II Cisplatin-pemetrexed Placebo | 15 |
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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.
Intervention | month (Median) |
---|
Phase II Cisplatin-pemetrexed Cediranib 20mg | 10 |
Phase II Cisplatin-pemetrexed Placebo | 8.5 |
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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
Intervention | proportion 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
Intervention | proportion 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
Intervention | percentage 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
Intervention | months (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
Intervention | months (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
Intervention | months (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.
Intervention | percentage of participants (Number) |
---|
Arm I: Observation | 100 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 1 | 90.7 |
Arm III: Randomized to Radiation Only in Stratum 1 | 86.4 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm I: Observation | 66.9 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 1 | 72.7 |
Arm III: Randomized to Radiation Only in Stratum 1 | 62.9 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm IV: Nonrandomly Assigned to Arm II Treatment | 33.6 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2 | 41.7 |
Arm III: Randomized to Radiation Only in Stratum 2 | 67.5 |
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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
Intervention | percentage of participants (Number) |
---|
Arm II: Randomized to Radiation With Maintenance Chemotherapy | 69.2 |
Arm III: Randomized to Radiation Only | 63.7 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm II: Randomized to Radiation With Maintenance Chemotherapy | 88.3 |
Arm III: Randomized to Radiation Only | 86.9 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2 | 69.2 |
Arm III: Randomized to Radiation Only in Stratum 2 | 89.5 |
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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.
Intervention | percentage of participants (Number) |
---|
Arm IV: Nonrandomly Assigned to Arm II Treatment | 74.0 |
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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
Intervention | dimensionless (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
Intervention | percentage of patients (Number) |
---|
SBRT and Chemo | 0 |
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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
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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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
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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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
Intervention | probability (Number) |
---|
SBRT and Chemo | 0 |
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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
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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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
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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Serum CA 19-9 Levels
Initial level of Cancer antigen 19-9 (NCT01151761)
Timeframe: 12 months
Intervention | U/ml (Mean) |
---|
SBRT and Chemo | 3329.1 |
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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
Intervention | Percentage 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
Intervention | Participants (Count of Participants) |
---|
Treatment (131I-MIBG, Chemotherapy) | 3 |
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Progression Free Survival (PFS)
(NCT01194453)
Timeframe: 36months
Intervention | day (Median) |
---|
Group A | 168 |
Group B | 140 |
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Response Rate
(NCT01194453)
Timeframe: 6 weeks
Intervention | percentage (Number) |
---|
Group A | 24.41 |
Group B | 14.17 |
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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
Intervention | participants (Number) |
---|
Sorafenib | 5 |
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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
Intervention | participants (Number) |
---|
Sorafenib | 0 |
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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
Intervention | participants (Number) |
---|
Sorafenib | 6 |
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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
Intervention | months (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
Intervention | Participants (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
Intervention | mg/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
Intervention | ng/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
Intervention | ng/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
Intervention | hr·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
Intervention | participants (Number) |
---|
| Partial Response | Stable Disease | Progression of Disease |
---|
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 3 | 5 | 6 |
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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
Intervention | Participants (Count of Participants) |
---|
| Insufficient tissue to asses any change | Sig decrease in post-treatment cleaved Notch |
---|
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 1 | 4 |
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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
Intervention | mg/m2 (Number) |
---|
| Cisplatin | Vinblastine | Temozolomide |
---|
Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 20 | 1.2 | 150 |
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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
Intervention | participants (Number) |
---|
Ph I Level 1: Cisplatin + Crolibulin | 6 |
Ph I Level 2: Cisplatin + Crolibulin | 1 |
Ph II Level 3: Cisplatin + Crolibulin | 16 |
Ph II Level 4: Cisplatin | 1 |
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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
Intervention | mg/m^2 (Number) |
---|
All Participants | 100 |
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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
Intervention | mg/m^2 (Number) |
---|
All Participants | 20 |
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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
Intervention | Participants (Count of Participants) |
---|
| Constipation | Fatigue | Diarrhea | Hyponatremia | Alanine Aminotransferase Increased | GGT Increased |
---|
Treatment (Granisetron, Dexamethasone, Aprepitant) | 1 | 1 | 1 | 1 | 1 | 1 |
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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
Intervention | Participants (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
Intervention | months (Median) |
---|
HIPEC | 13.99 |
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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
Intervention | months (Median) |
---|
HIPEC | 58.4 |
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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)
Intervention | Participants (Count of Participants) |
---|
| TEAE | TESAE |
---|
5FU+Cisplatin | 111 | 31 |
,S-1+Cisplatin | 214 | 63 |
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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)
Intervention | months (Median) |
---|
S-1+Cisplatin | 5.1 |
5FU+Cisplatin | 4.2 |
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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)
Intervention | Participants (Count of Participants) |
---|
S-1+Cisplatin | 157 |
5FU+Cisplatin | 78 |
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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)
Intervention | percentage of participants (Number) |
---|
S-1+Cisplatin | 34.7 |
5FU+Cisplatin | 19.8 |
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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)
Intervention | months (Median) |
---|
S-1+Cisplatin | 7.5 |
5FU+Cisplatin | 6.6 |
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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)
Intervention | months (Median) |
---|
S-1+Cisplatin | 4.4 |
5FU+Cisplatin | 3.9 |
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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)
Intervention | months (Median) |
---|
S-1+Cisplatin | 4.2 |
5FU+Cisplatin | 3.8 |
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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)
Intervention | months (Median) |
---|
S-1+Cisplatin | 1.8 |
5FU+Cisplatin | 1.9 |
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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
Intervention | units on a scale (Mean) |
---|
| Mean global QoL | Dysphagia score all |
---|
Chemotherapy | 69 | 31 |
,Radiochemotherapy | 67 | 27 |
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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.
Intervention | Participants (Count of Participants) |
---|
Radiochemotherapy | 22 |
Chemotherapy | 7 |
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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
Intervention | Participants (Count of Participants) |
---|
Radiochemotherapy | 79 |
Chemotherapy | 81 |
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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
Intervention | Percentage of participants (Number) |
---|
Standard Chemoradiation | 62 |
Standard Chemoradiation With Adjuvant Chemotherapy | 63 |
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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
Intervention | Percentage of participants (Number) |
---|
Standard Chemoradiation | 71 |
Standard Chemoradiation With Adjuvant Chemotherapy | 72 |
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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
Intervention | score on a scale (Mean) |
---|
Standard Chemoradiation | 1.7 |
Standard Chemoradiation With Adjuvant Chemotherapy | 2.4 |
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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
Intervention | Participants (Count of Participants) |
---|
| Abdominal pain | Alanine aminotransferase increased | Allergic reaction/hypersensitivity | Alopecia | Anemia | Aspartate aminotransferase increased | Colitis | Colonic obstruction | Creatinine Increased | Cystitis noninfective | Dehydration | Dermatitis radiation | Diarrhea | Enterocolitis | Fatigue | Febrile Neutropenia | Female genital tract fistula | Hearing impaired | Hemorrhage bladder | Hemorrhage rectum | Lymphocyte count decreased | Mucositis oral | Myalgia | Nausea | Neutrophil count decreased | Pain in extremity | Pelvic pain | Perineal pain | Peripheral motor neuropathy | Peripheral sensory neuropathy | Platelet count decreased | Proctitis | Small intestinal obstruction | Thrombosis/Thrombus/Embolism | Tumor pain | Urinary tract pain | Uterine obstruction | Vaginal Dryness | Vaginal pain | Vaginal stricture | Vomiting |
---|
Standard Chemoradiation | 13 | 4 | 1 | 0 | 32 | 3 | 2 | 1 | 3 | 1 | 13 | 1 | 21 | 2 | 7 | 9 | 4 | 0 | 3 | 1 | 208 | 2 | 0 | 11 | 33 | 3 | 11 | 1 | 0 | 1 | 5 | 2 | 1 | 7 | 6 | 1 | 1 | 0 | 3 | 4 | 9 |
,Standard Chemoradiation With Adjuvant Chemotherapy | 14 | 2 | 2 | 1 | 64 | 2 | 2 | 1 | 3 | 3 | 9 | 1 | 20 | 3 | 9 | 9 | 1 | 4 | 3 | 0 | 211 | 0 | 3 | 11 | 71 | 1 | 6 | 0 | 4 | 16 | 16 | 0 | 4 | 7 | 0 | 0 | 2 | 1 | 1 | 4 | 15 |
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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
Intervention | participants (Number) |
---|
| Persistent | Locoregional alone | Distant with or without locoregional | Other/Unknown | No Progression recorded |
---|
Standard Chemoradiation | 15 | 33 | 51 | 53 | 304 |
,Standard Chemoradiation With Adjuvant Chemotherapy | 5 | 47 | 42 | 37 | 332 |
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Radiation Protocol Compliance
Radiation protocol compliance measured by external beam dose delivered (NCT01414608)
Timeframe: Average duration of 7 weeks
Intervention | Gray (Mean) |
---|
Arm A | 45.6 |
Arm B | 45.7 |
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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.
Intervention | percentage of participants (Number) |
---|
Single Intervention | 95 |
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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
Intervention | percentage of participants (Number) |
---|
Single Intervention | 100 |
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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
Intervention | Participants (Count of Participants) |
---|
De-escalated Radiation and Chemotherapy | 37 |
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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
Intervention | units on a scale (Mean) |
---|
| Pain | Swallowing | Senses Problems | Speech Problems | Trouble with Social Eating | Trouble with Social Contact | Less Sexuality | Teeth | Opening Mouth | Dry Mouth | Sticky Saliva | Cough | Felt Ill | Pain Killers | Nutritional Supplements | Feeding Tube | Weight Loss | Weight Gain |
---|
6-8 Weeks Post-Treatment | 25 | 19 | 35 | 13 | 29 | 15 | 34 | 10 | 15 | 69 | 61 | 25 | 20 | 43 | 55 | 40 | 38 | 40 |
,Baseline | 19 | 11 | 5 | 10 | 8 | 5 | 13 | 3 | 5 | 16 | 6 | 17 | 8 | 34 | 39 | 0 | 20 | 25 |
,Post-Surgery | 26 | 18 | 28 | 16 | 24 | 8 | 23 | 12 | 18 | 64 | 49 | 22 | 11 | 33 | 40 | 17 | 36 | 10 |
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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
Intervention | percentage of participants (Number) |
---|
Single Intervention | 100 |
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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
Intervention | percentage of participants (Number) |
---|
De-escalated Radiation and Chemotherapy | 100 |
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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
Intervention | units on a scale (Mean) |
---|
| Global health status/QoL | Physical functioning | Role functioning | Emotional functioning | Cognitive functioning | Social functioning | Fatigue | Nausea and vomiting | Pain | Dyspnea | Insomnia | Appetite loss | Constipation | Diarrhea | Financial difficulties |
---|
6-8 Weeks Post-Treatment | 61 | 78 | 65 | 77 | 86 | 66 | 42 | 13 | 21 | 11 | 34 | 40 | 17 | 4 | 28 |
,Baseline | 80 | 96 | 96 | 77 | 91 | 88 | 20 | 2 | 15 | 5 | 23 | 14 | 12 | 5 | 16 |
,Post-Surgery | 69 | 85 | 77 | 84 | 87 | 81 | 31 | 4 | 20 | 6 | 23 | 33 | 16 | 6 | 22 |
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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
Intervention | units on a scale (Mean) |
---|
| Thin Substances | Pureed Substances | Solid Substances |
---|
Post-treatment | 1.90 | 1.19 | 1.03 |
,Pre-treatment | 1.30 | 1.03 | 1.03 |
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Patients With Adverse Events
Number of patients who experienced one or more adverse events (NCT01590017)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Cistplatin and Radiation Therapy | 39 |
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Treatment Completion Rate
Number of participants who completed therapy (NCT01590017)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|
Cistplatin and Radiation Therapy | 37 |
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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
Intervention | percentage of participants (Number) |
---|
GEM+CIS+IMRT | 75 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Leukopenia | Thrombocytopenia | Neutropenia | Anemia | Other Investigations | Other blood and lymphatic disorders | Cardiac disorders | Gastrointestinal disorders | General disorders and administration site conditions | Infections and infestations | Injury, poisoning and procedural complications | Metabolism and nutrition disorders | Musculoskeletal and connective tissue disorders | Peripheral sensory neuropathy | Other nervous system disorders | Renal and urinary disorders | Reproductive system and breast disorders | Respiratory, thoracic and mediastinal disorders | Skin and subcutaneous tissue disorders | Surgical and medical procedures | Vascular disorders |
---|
GEM+CIS+IMRT | 27 | 20 | 20 | 20 | 7 | 8 | 2 | 10 | 5 | 5 | 20 | 19 | 2 | 1 | 2 | 1 | 7 | 1 | 4 | 1 | 5 |
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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
Intervention | percentage of participants (Number) |
---|
GEM+CIS+IMRT | 73.6 |
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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
Intervention | percentage of participants (Number) |
---|
GEM+CIS+IMRT | 71.7 |
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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
Intervention | Participants (Count of Participants) |
---|
Induction Chemotherapy Followed by Transoral Surgery | 29 |
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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
Intervention | Participants (Count of Participants) |
---|
Induction Chemotherapy Followed by Transoral Surgery | 37 |
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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
Intervention | Participants (Count of Participants) |
---|
| Pathologic complete response (pCR) | Pathologic Partial Response (pPR) |
---|
Induction Chemotherapy Followed by Transoral Surgery | 14 | 25 |
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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
Intervention | units on a scale (Mean) |
---|
Pre-treatment | 83.90 |
Post-Induction | 86.26 |
1 Year Post Surgery | 81.90 |
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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
Intervention | Participants (Count of Participants) |
---|
| completed | not-completed |
---|
Induction Chemotherapy Followed by Transoral Surgery | 39 | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
| Alanine aminotransferase increased | Aspartate Aminotransferase increased | Chest pain- cardiac | Diarrhea | Fatigue | Febrile neutropenia | Hyperglycemia | Hyponatremia | Hypotension | Lymphocyte count decreased | Nausea | Neutrophil count decreased | Palmar-plantar erythrodysesthesia syndrome | Peripheral sensory neuropathy | Rash acneiform | Sepsis | White blood cell decreased |
---|
Induction Chemotherapy Followed by Transoral Surgery | 2 | 1 | 1 | 5 | 4 | 4 | 1 | 1 | 1 | 1 | 1 | 22 | 1 | 2 | 4 | 1 | 15 |
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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
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response | Stable Disease |
---|
Non-Randomized Single-Arm | 11 | 15 | 3 |
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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
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response | Stable Disease |
---|
Non-Randomized Single-Arm | 15 | 21 | 3 |
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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
Intervention | months (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
Intervention | units 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.
Intervention | percentage 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
Intervention | months (Median) |
---|
| Overall sample | Patients within the male/abnormal LDH stratum | Patients not within the male/abnormal LDH stratum |
---|
Phase II: Arm D (Veliparib) | 6.1 | 6.2 | 6.0 |
,Phase II: Arm E (Placebo) | 5.5 | 5.1 | 5.6 |
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Recommended Phase II Dose (Phase I)
dose of veliparib which was deemed to be the recommended phase II dose to be administered in the combination with CE for the phase II clinical trial (NCT01642251)
Timeframe: assessed for a maximum of cycle 1
Intervention | mg (Number) |
---|
Phase I | 100 |
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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
Intervention | Participants (Count of Participants) |
---|
Doxorubicin-Cyclophosphamide | 43 |
Cisplatin | 45 |
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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
Intervention | percentage of participants (Number) |
---|
Doxorubicin-Cyclophosphamide | 26 |
Cisplatin | 18 |
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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
Intervention | percentage of participants (Number) |
---|
Doxorubicin-Cyclophosphamide | 46 |
Cisplatin | 33 |
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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
Intervention | Adverse Events (Number) |
---|
| All Grade 3 & 4 Adverse Events | Non-hematologic Grade 3 & 4 Adverse Events |
---|
Cisplatin | 16 | 11 |
,Doxorubicin-Cyclophosphamide | 15 | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Doxorubicin-Cyclophosphamide | 30 |
Cisplatin | 22 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Not Assessable |
---|
Immunotherapy Plus Chemotherapy | 1 | 19 | 14 | 1 | 1 |
,Immunotherapy With Cyclophosphamide Plus Chemotherapy | 0 | 11 | 8 | 2 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
Immunotherapy Plus Chemotherapy | 38 |
Immunotherapy With Cyclophosphamide Plus Chemotherapy | 22 |
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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.
Intervention | Participants (Count of Participants) |
---|
Dose Level 1 | 2 |
Dose Level -1 | 1 |
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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).
Intervention | Participants (Count of Participants) |
---|
Dose Level 1 | 0 |
Dose Level -1 | 0 |
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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
Intervention | days (Median) |
---|
Dose Level 1 | 163 |
Dose Level -1 | 260 |
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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.
Intervention | days (Median) |
---|
Dose Level 1 | 159 |
Dose Level -1 | NA |
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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).
Intervention | Participants (Count of Participants) |
---|
Dose Level 1 | 0 |
Dose Level -1 | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Radiotherapy | 26 |
Radiotherapy, Cisplatin | 9 |
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Disease Specific Survival
(NCT01687413)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Radiotherapy | 24 |
Radiotherapy, Cisplatin | 10 |
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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
Intervention | score on a scale (Mean) |
---|
Baseline - Radiotherapy | 1.0833333 |
Baseline - Radiotherapy + Cisplatin | 0.9090909 |
1 Month - Radiotherapy | 2.1363636 |
1 Month - Radiotherapy + Cisplatin | 2.9090909 |
6 Months - Radiotherapy | 0.9285714 |
6 Months - Radiotherapy + Cisplatin | 2.4285714 |
12 Months - Radiotherapy | 1.0000000 |
12 Months - Radiotherapy + Cisplatin | 1.5714286 |
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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
Intervention | score 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 - Radiotherapy | 1.5454545 | 1.2727273 | 0.7272727 | 0.4545455 | 0.3636364 | 0.8636364 | 1.8181818 | 1.0000000 | 1.4090909 | 1.0909091 | 1.0000000 | 0.4090909 | 0.9090909 | 0.7727273 | 1.0000000 | 0.7727273 | 1.1363636 | 0.5454545 | 1.1818182 | 1.8636364 | 1.5454545 | 1.8181818 | 1.1363636 | 0.8181818 | 0.8636364 |
,1 Month - Radiotherapy + Cisplatin | 1.2727273 | 1.0000000 | 0.5454545 | 0.2727273 | 0.1818182 | 0.6363636 | 1.0909091 | 0.8181818 | 1.0909091 | 0.8181818 | 0.4545455 | 0.5454545 | 0.5454545 | 0.6363636 | 0.9090909 | 0.6363636 | 0.8181818 | 0.1818182 | 0.9090909 | 1.6363636 | 1.0000000 | 1.2727273 | 0.3636364 | 0.6363636 | 0.9090909 |
,12 Months - Radiotherapy | 1.4666667 | 1.333333 | 0.6666667 | 0.2666667 | 0.4666667 | 1.1333333 | 2.0000000 | 1.0666667 | 1.4000000 | 0.8666667 | 0.7857143 | 0.3333333 | 1.0666667 | 0.8000000 | 0.9333333 | 0.5333333 | 1.4000000 | 0.6666667 | 1.0000000 | 2.0666667 | 1.3333333 | 1.7333333 | 1.2666667 | 0.6666667 | 0.8000000 |
,12 Months - Radiotherapy + Cisplatin | 2.1666667 | 1.5000000 | 0.8333333 | 0.3333333 | 0.8333333 | 1.3333333 | 1.3333333 | 1.0000000 | 1.8333333 | 0.8333333 | 0.8333333 | 0.5000000 | 1.0000000 | 0.6666667 | 1.0000000 | 0.8333333 | 1.3333333 | 0.3333333 | 0.8333333 | 1.6666667 | 2.3333333 | 2.0000000 | 1.1666667 | 1.3333333 | 1.1666667 |
,24 Months - Radiotherapy | 1.5625000 | 1.4375000 | 0.6250000 | 0.3750000 | 0.3125000 | 0.7333333 | 1.6250000 | 1.2500000 | 1.4375000 | 0.8125000 | 0.8125000 | 0.3125000 | 0.8750000 | 0.7500000 | 1.0625000 | 0.6250000 | 1.1250000 | 0.6250000 | 1.0000000 | 1.8125000 | 1.3125000 | 1.6250000 | 0.7500000 | 1.0000000 | 1.0000000 |
,24 Months - Radiotherapy + Cisplatin | 1.5714286 | 1.4285714 | 0.8571429 | 0.5714286 | 0.5714286 | 1.2857143 | 1.4285714 | 0.8571429 | 1.5714286 | 1.4285714 | 1.0000000 | 0.2857143 | 0.7142857 | 0.8571429 | 1.1428571 | 1.0000000 | 1.5714286 | 0.5714286 | 0.8571429 | 1.8571429 | 1.4285714 | 1.5714286 | 0.7142857 | 0.8571429 | 1.0000000 |
,Baseline - Radiotherapy | 1.4166667 | 1.2083333 | 0.6666667 | 0.3333333 | 0.2500000 | 0.9583333 | 1.7083333 | 1.0000000 | 1.3750000 | 0.9583333 | 0.6666667 | 0.4782609 | 0.6250000 | 0.5833333 | 0.9583333 | 0.5833333 | 1.0416667 | 0.5416667 | 1.1250000 | 1.8333333 | 1.2500000 | 1.4166667 | 0.8333333 | 0.4583333 | 0.7916667 |
,Baseline - Radiotherapy + Cisplatin | 1.3636364 | 1.0909091 | 0.3636364 | 0.2727273 | 0.1818182 | 0.6363636 | 1.0909091 | 0.9090909 | 1.2727273 | 1.0000000 | 0.6363636 | 0.4545455 | 0.4545455 | 0.6363636 | 0.9090909 | 0.5454545 | 1.00000000 | 0.1818182 | 1.2727273 | 1.6363636 | 1.0909091 | 1.4545455 | 0.6363636 | 0.8181818 | 0.5454545 |
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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
Intervention | score 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 - Radiotherapy | 0.2380952 | 0.5238095 | 0.6666667 | 0.3809524 | 0.1428571 | 0.5238095 | 0.6190476 | 0.0000000 | 0.1000000 | 0.8571429 | 0.1904762 |
,1 Month - Radiotherapy + Cisplatin | 0.1818182 | 0.3636364 | 1.0909091 | 0.7272727 | 0.3636364 | 0.2727273 | 0.8181818 | 0.0000000 | 0.1818182 | 0.4545455 | 0.4545455 |
,12 Months - Radiotherapy | 0.1333333 | 0.1333333 | 0.1333333 | 0.2000000 | 0.0666667 | 0.1333333 | 0.2666667 | 0.0000000 | 0.2666667 | 0.4000000 | 0.1333333 |
,12 Months - Radiotherapy + Cisplatin | 1.0000000 | 0.7142857 | 1.7142857 | 0.7142857 | 0.7142857 | 0.4285714 | 1.5714286 | 0.0000000 | 0.1428571 | 0.7142857 | 0.7142857 |
,Baseline - Radiotherapy | 0.2500000 | 0.1250000 | 0.5000000 | 0.1666667 | 0.1250000 | 0.1666667 | 0.2173913 | 0.0416667 | 0.2500000 | 0.3750000 | 0.3333333 |
,Baseline - Radiotherapy + Cisplatin | 0.5454545 | 0.1818182 | 1.0909091 | 0.6363636 | 0.5454545 | 0.4545455 | 0.7272727 | 0.1818182 | 0.1818182 | 0.4545455 | 0.6363636 |
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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
Intervention | score 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 television | Did 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 - Radiotherapy | 1.7727273 | 1.3636364 | 1.0454545 | 1.2272727 | 1.0909091 | 1.4090909 | 1.4545455 | 1.1363636 | 1.5000000 | 1.5909091 | 1.5454545 | 1.6818182 | 1.6363636 | 1.1818182 | 1.0454545 | 1.6363636 | 1.1363636 | 1.181818 | 1.2380952 | 1.2857143 | 1.4090909 | 1.4545455 | 1.4090909 | 1.3181818 | 1.5454545 | 1.3181818 | 1.5909091 | 1.5909091 | 5.4090909 | 5.6363636 |
,1 Month - Radiotherapy + Cisplatin | 1.4545455 | 1.2727273 | 1.0000000 | 1.0909091 | 1.0000000 | 1.2727273 | 1.4545455 | 1.3636364 | 1.7272727 | 1.6363636 | 1.6363636 | 1.4545455 | 1.3636364 | 1.1818182 | 1.0000000 | 1.0909091 | 1.0000000 | 1.7272727 | 1.3000000 | 1.2727273 | 1.2727273 | 1.2727273 | 1.2727273 | 1.1818182 | 1.6363636 | 1.3636364 | 1.7272727 | 1.9090909 | 5.5454545 | 5.6363636 |
,12 Months - Radiotherapy | 1.2666667 | 1.2666667 | 1.0000000 | 1.2666667 | 1.0000000 | 1.2000000 | 1.1333333 | 1.2666667 | 1.6000000 | 1.6000000 | 1.9333333 | 1.3333333 | 1.2000000 | 1.1333333 | 1.0000000 | 1.1333333 | 1.2000000 | 1.7333333 | 1.3333333 | 1.4000000 | 1.4000000 | 1.4000000 | 1.3333333 | 1.3333333 | 1.6000000 | 1.2000000 | 1.3333333 | 1.4666667 | 6.0666667 | 6.1333333 |
,12 Months - Radiotherapy + Cisplatin | 1.5714286 | 1.1428571 | 1.1428571 | 1.2857143 | 1.2857143 | 1.2857143 | 1.4285714 | 1.4285714 | 1.8571429 | 1.8571429 | 2.0000000 | 1.5714286 | 1.2857143 | 1.0000000 | 1.0000000 | 1.5714286 | 1.1428571 | 2.1428571 | 1.5714286 | 1.5714286 | 1.4285714 | 2.0000000 | 1.8571429 | 1.7142857 | 2.1428571 | 1.5714286 | 1.5714286 | 1.8571429 | 5.5714286 | 5.7142857 |
,24 Months - Radiotherapy | 1.4375000 | 1.2500000 | 1.0000000 | 1.1875000 | 1.0000000 | 1.3750000 | 1.2500000 | 1.1875000 | 1.6875000 | 1.6875000 | 1.3750000 | 1.5625000 | 1.5000000 | 1.1875000 | 1.0000000 | 1.4000000 | 1.0666667 | 1.4375000 | 1.1333333 | 1.3125000 | 1.1875000 | 1.4375000 | 1.3125000 | 1.3125000 | 1.4375000 | 1.0625000 | 1.1250000 | 1.4375000 | 5.7500000 | 6.0000000 |
,24 Months - Radiotherapy + Cisplatin | 1.6250000 | 1.2500000 | 1.1250000 | 1.0000000 | 1.0000000 | 1.0000000 | 1.3750000 | 1.3750000 | 2.0000000 | 1.6250000 | 2.1250000 | 1.3750000 | 1.1250000 | 1.0000000 | 1.0000000 | 1.7500000 | 1.1250000 | 1.7500000 | 1.0000000 | 1.2500000 | 1.7500000 | 2.0000000 | 1.6250000 | 1.5000000 | 1.8750000 | 1.1250000 | 1.3750000 | 1.8750000 | 5.7500000 | 6.0000000 |
,6 Months - Radiotherapy | 1.3571429 | 1.2142857 | 1.0714286 | 1.1428571 | 1.0714286 | 1.4285714 | 1.2857143 | 1.1428571 | 1.7142857 | 1.5000000 | 1.3571429 | 1.5384615 | 1.3571429 | 1.2142857 | 1.0714286 | 1.2142857 | 1.1428571 | 1.6428571 | 1.2857143 | 1.3571429 | 1.2857143 | 1.3571429 | 1.1428571 | 1.2142857 | 1.7142857 | 1.2142857 | 1.1428571 | 1.7142857 | 5.9285714 | 6.1428571 |
,6 Months - Radiotherapy + Cisplatin | 1.7142857 | 1.1428571 | 1.1428571 | 1.2857143 | 1.1428571 | 1.1428571 | 1.4285714 | 1.4285714 | 1.8571429 | 1.7142857 | 2.4285714 | 1.4285714 | 1.2857143 | 1.1428571 | 1.0000000 | 1.1428571 | 1.1428571 | 1.8571429 | 1.4285714 | 1.5714286 | 1.5714286 | 2.0000000 | 1.7142857 | 1.5714286 | 1.8571429 | 1.4285714 | 1.7142857 | 2.1428571 | 5.2857143 | 5.4285714 |
,Baseline - Radiotherapy | 2.0000000 | 1.7500000 | 1.0833333 | 1.4583333 | 1.0833333 | 2.0833333 | 2.0000000 | 1.2916667 | 2.0000000 | 1.9166667 | 1.8333333 | 1.9166667 | 1.6956522 | 1.1666667 | 1.0833333 | 1.5000000 | 1.0416667 | 2.0000000 | 1.6666667 | 1.4583333 | 1.3750000 | 1.9166667 | 1.4166667 | 1.5416667 | 1.4166667 | 1.7916667 | 2.0416667 | 1.5416667 | 5.2083333 | 5.0416667 |
,Baseline - Radiotherapy + Cisplatin | 2.0000000 | 1.0909091 | 1.0000000 | 1.0000000 | 1.0909091 | 1.6363636 | 1.6363636 | 1.0000000 | 1.7272727 | 1.5454545 | 2.2727273 | 1.8181818 | 1.6363636 | 1.3636364 | 1.0000000 | 1.8181818 | 1.1818182 | 2.0000000 | 1.7272727 | 1.2727273 | 1.5454545 | 2.0000000 | 1.5454545 | 1.4545455 | 1.2727273 | 1.5454545 | 1.9090909 | 2.3636364 | 5.2727273 | 5.1818182 |
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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
Intervention | score on a scale (Mean) |
---|
| Neck or shoulder pain or discomfort | Neck or shoulder stiffness | Difficulty with self-care activities because of neck or shoulder | Limited ability to life light objects because of your shoulder or neck | Limited ability to lift heavy objects because of your shoulder or neck | Limited ability to reach for objects because of your shoulder or neck | Overall activity level because of your shoulder or neck | Has 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 - Radiotherapy | 1.4666667 | 1.0000000 | 0.3333333 | 0.4000000 | 0.5333333 | 0.5333333 | 0.5333333 | 0.0666667 | 0.2000000 | 0.2666667 |
,12 Months - Radiotherapy + Cisplatin | 2.4285714 | 2.4285714 | 1.0000000 | 0.8571429 | 1.5714286 | 1.7142857 | 1.5714286 | 0.8571429 | 1.4285714 | 1.2857143 |
,24 Months - Radiotherapy | 1.3125000 | 1.1875000 | 0.2500000 | 0.2500000 | 0.4666667 | 0.5625000 | 0.3750000 | 0.1875000 | 0.2500000 | 0.1250000 |
,24 Months - Radiotherapy + Cisplatin | 1.7500000 | 1.7500000 | 0.5000000 | 0.5000000 | 0.8750000 | 0.7500000 | 0.6250000 | 0.5000000 | 0.7500000 | 0.5000000 |
,Baseline - Radiotherapy | 1.6086957 | 1.4545455 | 0.8695652 | 0.6521739 | 1.6086957 | 1.2173913 | 1.0000000 | 0.7391304 | 1.0869565 | 1.1304348 |
,Baseline - Radiotherapy + Cisplatin | 2.0909091 | 2.0000000 | 1.2727273 | 1.6363636 | 2.2727273 | 2.0909091 | 1.9090909 | 0.9090909 | 1.7272727 | 1.7272727 |
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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
Intervention | score on a scale (Mean) |
---|
| My speech makes it difficult for people to understand me | I run out of air when I speak | The intelligibility of my speech varies throughout the day | My speech makes me feel incompetent | People ask me why I'm hard to understand | I feel annoyed when people ask me to repeat | I avoid using the phone | I'm tense when talking to others because of my speech | My articulation is unclear | People have difficulty understanding me in a noisy room | I tend to avoid groups of people because of my speech | People seem irritated with my speech | People ask me to repeat myself when speaking face-to-face | I speak with friends and neighbors and relatives less often because of my speech | I feel ask though I have to strain to speak | I find other people don't understand my speaking problem | My speaking difficulties restrict my person and social life | The intelligibility is unpredictable | I feel left out of conversations because of my speech | I use a great deal of effort to speak | My speech is worse in the evening | My speech problem causes me to lose income | I try to change my speech to sound different | My speech problem upsets me | I am less outgoing because of my speech problem | My family has difficulty understanding me when I call them throughout the house | My speech makes me feel handicapped | I have difficulties to continue a conversation because of my speech | I feel embarrassed when people ask me to repeat | I'm ashamed of my speech problem | How do you rate your own speech at this moment? |
---|
12 Months - Radiotherapy | 1.3333333 | 1.2666667 | 1.4000000 | 1.1333333 | 1.1333333 | 1.3333333 | 1.1333333 | 1.0666667 | 1.4666667 | 1.6000000 | 1.2666667 | 1.1333333 | 1.3333333 | 1.2666667 | 1.2000000 | 1.0666667 | 1.2000000 | 1.1333333 | 1.3333333 | 1.2666667 | 1.3333333 | 1.0000000 | 1.0666667 | 1.2666667 | 1.0666667 | 1.1333333 | 1.0666667 | 1.1333333 | 1.0000000 | 1.0000000 | 1.3846154 |
,12 Months - Radiotherapy + Cisplatin | 1.8333333 | 1.8333333 | 1.8333333 | 1.5000000 | 1.3333333 | 1.6666667 | 1.6666667 | 1.6666667 | 1.8333333 | 1.8333333 | 1.8333333 | 1.5000000 | 1.8333333 | 1.5000000 | 2.0000000 | 1.3333333 | 1.5000000 | 1.5000000 | 1.4285714 | 1.8571429 | 1.8571429 | 1.4285714 | 1.2857143 | 1.8571429 | 1.4285714 | 1.5714286 | 1.5714286 | 1.8571429 | 1.2857143 | 1.2857143 | 1.5714286 |
,Baseline - Radiotherapy | 1.9565217 | 1.5000000 | 2.0000000 | 1.3750000 | 1.2916667 | 1.3750000 | 1.6250000 | 1.4166667 | 1.8333333 | 1.8750000 | 1.2500000 | 1.1250000 | 1.5416667 | 1.4166667 | 1.833333 | 1.1666667 | 1.3750000 | 1.5833333 | 1.2083333 | 1.8750000 | 1.6250000 | 1.2916667 | 1.2916667 | 1.2083333 | 1.2500000 | 1.5000000 | 1.3333333 | 1.5000000 | 1.2083333 | 1.0833333 | 2.1304348 |
,Baseline - Radiotherapy + Cisplatin | 1.7272727 | 1.4545455 | 1.5454545 | 1.2727273 | 1.1818182 | 1.2727273 | 1.5454545 | 1.5454545 | 1.8181818 | 1.8181818 | 1.727277 | 1.3636364 | 1.7272727 | 1.2727273 | 1.9090909 | 1.2727273 | 1.2727273 | 1.3636364 | 1.3636364 | 1.6363636 | 1.6363636 | 1.8181818 | 1.0909091 | 1.5454545 | 1.4545455 | 1.6363636 | 1.4545455 | 1.5454545 | 1.3636364 | 1.2727273 | 1.4545455 |
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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
Intervention | score 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 - Radiotherapy | 4.1818182 | 4.1818182 | 3.8095238 | 3.9090909 | 2.8636364 | 3.7727273 | 3.9545455 | 4.3181818 | 4.5000000 | 3.1818182 | 4.0000000 | 4.5454545 |
,1 Month - Radiotherapy + Cisplatin | 4.1818182 | 4.4545455 | 4.0909091 | 4.1818182 | 2.6363636 | 4.2727273 | 3.9090909 | 4.1818182 | 4.3636364 | 2.9090909 | 3.7272727 | 4.3636364 |
,12 Months - Radiotherapy | 4.5000000 | 4.4285714 | 4.2857143 | 4.0769231 | 2.7857143 | 4.2142857 | 3.9285714 | 4.6428571 | 4.6428571 | 3.5000000 | 4.2142857 | 4.5714286 |
,12 Months - Radiotherapy + Cisplatin | 3.2857143 | 3.1428571 | 4.1428571 | 3.7142857 | 3.1428571 | 3.7142857 | 3.1428571 | 4.1428571 | 3.8571429 | 3.0000000 | 3.0000000 | 4.1428571 |
,24 Months - Radiotherapy | 3.9375000 | 4.1250000 | 4.4000000 | 3.6875000 | 3.0625000 | 3.9375000 | 3.5625000 | 4.1875000 | 4.6000000 | 2.8750000 | 4.1875000 | 4.3750000 |
,24 Months - Radiotherapy + Cisplatin | 4.6250000 | 4.1250000 | 4.7500000 | 4.5000000 | 3.2500000 | 4.1250000 | 3.3750000 | 4.2500000 | 4.5000000 | 3.1250000 | 4.5000000 | 4.3750000 |
,6 Months - Radiotherapy | 4.3076923 | 4.3846154 | 4.6153846 | 4.3846154 | 3.1538462 | 3.7692308 | 3.6923077 | 4.5384615 | 4.6153846 | 3.0769231 | 4.1538462 | 4.6923077 |
,6 Months - Radiotherapy + Cisplatin | 3.5714286 | 3.8571429 | 3.8571429 | 3.7142857 | 2.2857143 | 3.1428571 | 3.0000000 | 3.8571429 | 4.0000000 | 2.1428571 | 3.4285714 | 3.8571429 |
,Baseline - Radiotherapy | 3.2608696 | 3.5454545 | 3.3636364 | 3.3913043 | 3.2272727 | 3.2173913 | 3.0869565 | 3.9130435 | 4.2608696 | 2.5909091 | 4.0869565 | 4.2608696 |
,Baseline - Radiotherapy + Cisplatin | 4.0000000 | 4.4545455 | 4.5454545 | 4.0909091 | 2.0909091 | 3.9090909 | 3.4545455 | 4.6363636 | 3.9090909 | 2.4000000 | 4.0000000 | 4.2727273 |
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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
Intervention | score on a scale (Mean) |
---|
| Rate your difficulty in talking due to dryness | Rate your difficulty chewing due to dryness | Rate your difficulty in swallowing solid food due to dryness | Rate the frequency of your sleeping problems due to dryness | Rate your mouth or throat dryness when eating food | Rate your mouth or throat dryness while not eating | Rate the frequency of sipping liquids to aid swallowing food | Rate the frequency of sipping liquids for oral comfort when not eating |
---|
1 Month - Radiotherapy | 2.8095238 | 3.5238095 | 3.4285714 | 3.2857143 | 3.8571429 | 3.8571429 | 5.1428571 | 4.6190476 |
,1 Month - Radiotherapy + Cisplatin | 3.9090909 | 3.1818182 | 3.9000000 | 3.0000000 | 3.7272727 | 3.0909091 | 4.0000000 | 3.3636364 |
,12 Months - Radiotherapy | 2.5625000 | 2.6250000 | 3.3750000 | 2.2500000 | 3.5000000 | 3.2500000 | 5.0625000 | 3.8750000 |
,12 Months - Radiotherapy + Cisplatin | 3.5714286 | 3.7142857 | 4.1428571 | 3.5714286 | 4.0000000 | 3.4285714 | 5.0000000 | 3.7142857 |
,24 Months - Radiotherapy | 3.6875000 | 3.6250000 | 4.1250000 | 2.6000000 | 3.8750000 | 3.7500000 | 5.3125000 | 4.0000000 |
,24 Months - Radiotherapy + Cisplatin | 3.1250000 | 2.7500000 | 3.2500000 | 2.7500000 | 3.3750000 | 2.6250000 | 4.1250000 | 2.7500000 |
,6 Months - Radiotherapy | 3.0000000 | 3.0714286 | 3.5000000 | 1.7142857 | 3.5000000 | 2.6428571 | 5.0000000 | 3.4285714 |
,6 Months - Radiotherapy + Cisplatin | 4.8571429 | 4.5714286 | 5.2857143 | 4.4285714 | 5.7142857 | 4.7142857 | 6.7142857 | 5.2857143 |
,Baseline - Radiotherapy | 2.3333333 | 2.3913043 | 2.6956522 | 1.7916667 | 2.2173913 | 2.1250000 | 3.1739130 | 2.9565217 |
,Baseline - Radiotherapy + Cisplatin | 1.3636364 | 1.4545455 | 1.6363636 | 1.5454545 | 1.8181818 | 1.5454545 | 2.2727273 | 2.0909091 |
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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
Intervention | number of adverse events (Number) |
---|
| Blood and lymphatic system disorders | Cardiac disorders | Ear and labyrinth disorders | Eye disorders | Gastrointestinal disorders | General disorders | Immune system disorders | Infections and infestations | Injury, poisoning and procedureal complications | Investigations | Metabolism and nutrition disorders | Musculoskeletal and connective tissue disorders | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Nervous system disorders | Psychiatric disorders | Respiratory, thoracic and mediastinal disorders | Skin and subcutaneous tissue disorders | Surgical and medical procedures | Vascular disorders |
---|
Radiotherapy | 5 | 0 | 11 | 2 | 104 | 38 | 1 | 7 | 31 | 20 | 11 | 15 | 1 | 48 | 16 | 34 | 32 | 3 | 11 |
,Radiotherapy, Cisplatin | 12 | 1 | 4 | 0 | 61 | 17 | 0 | 2 | 9 | 60 | 26 | 9 | 0 | 29 | 9 | 14 | 14 | 0 | 6 |
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Number of Participants With Disease-free Survival (DFS)
(NCT01687413)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Radiotherapy | 24 |
Radiotherapy, Cisplatin | 10 |
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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
Intervention | Participants (Count of Participants) |
---|
| Grade 3 Adverse Event | Grade 4 Adverse Event | Grade 5 Adverse Event |
---|
Dose Level 0 | 0 | 3 | 0 |
,Dose Level 0B | 2 | 1 | 0 |
,Dose Level 1 | 2 | 1 | 0 |
,Dose Level 2 | 4 | 0 | 0 |
,Dose Level 3 | 6 | 1 | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Dose Level 0 | 0 |
Dose Level 0B | 0 |
Dose Level 1 | 0 |
Dose Level 2 | 0 |
Dose Level 3 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
Milestones Related to Usual Therapy | 107 |
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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
Intervention | Months (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)
Intervention | Participants (Count of Participants) |
---|
Milestones Related to Usual Therapy | 92 |
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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
Intervention | Participants (Count of Participants) |
---|
Milestones Related to Usual Therapy | 36 |
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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)
Intervention | Participants (Count of Participants) |
---|
20 mg Afatinib | 2 |
30 mg Afatinib | 3 |
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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)
Intervention | mg (Number) |
---|
All Study Participants | 20 |
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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
Intervention | participants (Number) |
---|
All Patients | 9 |
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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
Intervention | months (Median) |
---|
EGFR: Erlotinib | 21.1 |
EGFR: No Erlotinib | 9.2 |
ALK: Crizotinib | 14.7 |
ALK: No Crizotinib | NA |
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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
Intervention | percentage of participants (Number) |
---|
EGFR: Erlotinib | 50.0 |
EGFR: No Erlotinib | 26.7 |
ALK: Crizotinib | 66.7 |
ALK: No Crizotinib | 75.0 |
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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
Intervention | Months (Median) |
---|
EGFR: Erlotinib | NA |
EGFR: No Erlotinib | 35.9 |
ALK: Crizotinib | NA |
ALK: No Crizotinib | NA |
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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
Intervention | Participants (Count of Participants) |
---|
EGFR: Erlotinib | 0 |
EGFR: No Erlotinib | 0 |
ALK: Crizotinib | 0 |
ALK: No Crizotinib | 0 |
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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
Intervention | Months (Median) |
---|
EGFR: Erlotinib | 25.7 |
EGFR: No Erlotinib | NA |
ALK: Crizotinib | 14.7 |
ALK: No Crizotinib | NA |
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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
Intervention | Months (Median) |
---|
EGFR: Erlotinib | NA |
EGFR: No Erlotinib | 35.9 |
ALK: Crizotinib | NA |
ALK: No Crizotinib | 20.1 |
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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
Intervention | months (Median) |
---|
Nab-Pac+Cis+Gem | 16.4 |
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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
Intervention | months (Median) |
---|
Nab-Pac+Cis+Gem | 10.1 |
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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
Intervention | percentage 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
Intervention | score 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
Intervention | proportion 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
Intervention | score 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
Intervention | score 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
Intervention | proportion 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)
Intervention | Months (Median) |
---|
| Phase II | Phase III |
---|
Nintedanib | 9.36 | 6.77 |
,Placebo | 5.72 | 6.97 |
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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)
Intervention | Months (Median) |
---|
| Phase II | Phase III |
---|
Nintedanib | 18.30 | 14.36 |
,Placebo | 14.46 | 16.07 |
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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
Intervention | Percentage of participants (Number) |
---|
Placebo | 42.8 |
Nintedanib | 45.0 |
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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
Intervention | Percentage of participants (Number) |
---|
Placebo | 92.6 |
Nintedanib | 90.8 |
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Maximum Tolerated Dose(MTD) of GDC-0941 and Recommended Phase II Dose of GDC-0941 Given in Combination With Cisplatin. - (Phase Ib)
"GDC-0941 dose will start at 260 mg (maximum dose). De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level of GDC-0941 260mg.~MTD is defined as the highest dose at which a DLT is experienced >= 1 out of 6 patients.~A cohort of 3 patients was initially enrolled in the GDC-0941 arm at dose 260mg PO days 2-6, 9-13, 16-20, 23-27 of 28 day cycle~If no patient in the first cohort of 3 experiences a DLT, an additional cohort of 3 patients will be treated at the same dose level.~If 1 patient experiences a DLT in the first cohort, an additional cohort of 3 patients will be treated at the same dose level.~If ≤1 patient has a DLT in 6 treated at this same dose, this will be considered a tolerable dose to move to phase II.~If 2 or more patients in 3 or 6 patients treated at a given dose experience DLT, the dose will be de-escalated to the next lower dose level." (NCT01918306)
Timeframe: 4 weeks
Intervention | mg (Number) |
---|
1PHIbA -Cisplatin and GDC-0941 | 260 |
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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
Intervention | participants (Number) |
---|
1PHIbA - Cisplatin and GDC-0941 Cohort 1 | 0 |
1 PHIbA - Arm 1 - Cisplatin and GDC-0941Cohort 2 | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
2PHII1 Arm 1 Cisplatin | 0 |
2PHII2 Arm 2 - Cisplatin and GDC-0941 | 1 |
2PHIICO - Crossover to Arm 2 - Cisplatin and GDC-0941 | 0 |
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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
Intervention | days to progression (Median) |
---|
2PHII1 - Arm 1 - Cisplatin | 24.5 |
2PHII2 - Arm 2 - Cisplatin and GDC-0941 | NA |
2PHIICO - Crossover to Arm 2 - Cistplatin + GDC - 0941 | 33 |
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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 Cisplatin | 0 |
2PHII2 - ARM 2 - Cisplatin and GDC-0941 | 0 |
2PHIICO - Crossover to 2 - Cisplatin + GDC-0941 | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Sirolimus, Cisplatin, Gemcitabine | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Phase 1 - Sirolimus, Cisplatin, Gemcitabine | 0 |
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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.
Intervention | probability (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.
Intervention | Participants (Count of Participants) |
---|
| Responder (RCB-0/1) | Non-Responder (RCB-2/3 or crossover) |
---|
Arm A: Cisplatin With HRD- | 2 | 15 |
,Arm A: Cisplatin With HRD+ | 9 | 30 |
,Arm B: Paclitaxel With HRD- | 4 | 9 |
,Arm B: Paclitaxel With HRD+ | 10 | 25 |
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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
Intervention | log [mg/mL] (Geometric Mean) |
---|
Gefapixant 50 | 0.91 |
Gefapixant 300 | 0.84 |
Placebo | 0.82 |
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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
Intervention | Liters (Mean) |
---|
| + 5 minutes | +15 minutes | +30 minutes | +45 minutes | +60 minutes | +90 minutes | Minimum Highest FEV1 |
---|
Gefapixant 300 | 2.43 | 2.67 | 2.83 | 2.99 | 3.06 | 3.12 | 2.43 |
,Gefapixant 50 | 2.53 | 2.72 | 2.93 | 3.02 | 3.11 | 3.15 | 2.53 |
,Placebo | 2.54 | 2.77 | 2.94 | 3.03 | 3.14 | 3.18 | 2.54 |
,Screening | 2.44 | 2.69 | 2.86 | 2.93 | 2.99 | 3.10 | 2.44 |
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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)
Intervention | participants (Number) |
---|
| With any adverse events (AEs) | With any serious AEs (SAEs) | With any AEs Grade ≥ 3 | With any drug related (possible/probable) AEs | With any drug related (possible/probable) SAEs | With any AEs leading to study drug withdrawal | With any AEs leading to death | With AEs of Special Interest | With pregnancy |
---|
Chemotherapy-Erlotinib | 12 | 1 | 2 | 9 | 0 | 0 | 0 | 0 | 0 |
,Erlotinib-Chemotherapy | 14 | 0 | 5 | 10 | 0 | 0 | 0 | 0 | 0 |
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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)
Intervention | Months (Median) |
---|
Erlotinib-Chemotherapy | 26.3 |
Chemotherapy-Erlotinib | 23.4 |
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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.
Intervention | Participants (Count of Participants) |
---|
CetuGEX | 88 |
Cetuximab | 94 |
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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.
Intervention | Participants (Count of Participants) |
---|
CetuGEX | 52 |
Cetuximab | 57 |
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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.
Intervention | weeks (Median) |
---|
CetuGEX | 49.7 |
Cetuximab | 59.0 |
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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
Intervention | weeks (Median) |
---|
CetuGEX | 27.7 |
Cetuximab | 26.4 |
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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
Intervention | weeks (Median) |
---|
CetuGEX in Combination With Chemotherapy | 43.4 |
Cetuximab in Combination With Chemotherapy | 31.3 |
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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.
Intervention | weeks (Median) |
---|
CetuGEX | 22.1 |
Cetuximab | 23.3 |
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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
Intervention | percentage of participants (Number) |
---|
Photodynamic Therapy-Photofrin Plus SMC | 56 |
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
Intervention | days (Median) |
---|
Photodynamic Therapy-Photofrin Plus SMC | 444 |
Standard Medical Care (SMC) | 387 |
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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)
Intervention | subjects (Number) |
---|
| TEAEs | Serious TEAEs | TEAE leading to Discontinuation | TEAEs Leading to Death |
---|
Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel | 3 | 3 | 0 | 0 |
,Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine | 3 | 3 | 1 | 0 |
,Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed | 6 | 5 | 3 | 0 |
,Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel | 3 | 3 | 2 | 0 |
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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
Intervention | Subjects (Number) |
---|
| Investigator | SMC |
---|
Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel | 1 | 0 |
,Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine | 2 | 2 |
,Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed | 1 | 1 |
,Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel | 0 | 0 |
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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
Intervention | Months (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
Intervention | Months (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
Intervention | mg/m2 (Number) |
---|
| Docetaxel | Cisplatin |
---|
Phase 1 | 60 | 60 |
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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.
Intervention | percentage of participants (Number) |
---|
Phase 2 | 25 |
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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
Intervention | percentage of participants (Number) |
---|
Phase 2 | 61 |
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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
Intervention | mg (Number) |
---|
Phase 1 | 400 |
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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)
Intervention | Participants (Number) |
---|
Total Therapy 5B | 0 |
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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
Intervention | months (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
Intervention | adverse 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
Intervention | Participants (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
Intervention | months (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
Intervention | months (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
Intervention | percentage of participants (Number) |
---|
| End of RT | 1 month post-RT | 6 months post-RT | 1 year post-RT | 2 years post-RT |
---|
IMRT 5 Weeks (Arm 2) | 46.3 | 28.2 | 11.1 | 9.0 | 7.4 |
,IMRT 6 Weeks + Cisplatin (Arm 1) | 73.7 | 36.1 | 17.9 | 14.0 | 8.6 |
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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
Intervention | percentage of participants (Number) |
---|
| Six months | Two years |
---|
IMRT 5 Weeks | 98.0 | 97.3 |
,IMRT 6 Weeks + Cisplatin | 99.3 | 96.7 |
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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
Intervention | percentage of participants (Number) |
---|
| Six months | Two years |
---|
IMRT 5 Weeks | 2.0 | 9.5 |
,IMRT 6 Weeks + Cisplatin | 0.7 | 3.3 |
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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)
Intervention | percentage of participants (Number) |
---|
| Progression-free Survival | Local-regional failure |
---|
Both Arms Combined | 92.0 | 94.5 |
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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
Intervention | percentage 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
Intervention | score 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
Intervention | participants (Number) |
---|
Resectable Disease | 0 |
Unresectable Disease | 0 |
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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).
Intervention | Participants (Count of Participants) |
---|
De-escalated Radiation and Chemotherapy | 105 |
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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).
Intervention | Participants (Count of Participants) |
---|
De-escalated Radiation and Chemotherapy | 106 |
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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).
Intervention | Participants (Count of Participants) |
---|
De-escalated Radiation and Chemotherapy | 110 |
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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)
Intervention | Participants (Count of Participants) |
---|
De-escalated Radiation and Chemotherapy | 99 |
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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).
Intervention | Participants (Count of Participants) |
---|
De-escalated Radiation and Chemotherapy | 107 |
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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
Intervention | Participants (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-3475 | 2 | 1 | 1 | 0 | 0 | 2 | 3 | 1 | 1 | 1 | 1 | 1 |
,Cohort 2: Neoadjuvant MK-3475 | 3 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 5 |
Cohort 2: Neoadjuvant MK-3475 | 6 |
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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)
Intervention | Participants (Count of Participants) |
---|
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 2 |
Cohort 2: Neoadjuvant MK-3475 | 2 |
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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)
Intervention | Participants (Count of Participants) |
---|
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 3 |
Cohort 2: Neoadjuvant MK-3475 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| pTR-0 | pTR-1 | pTR-2 |
---|
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 20 | 8 | 8 |
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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)
Intervention | Participants (Count of Participants) |
---|
| pTR-0 | pTR-1 | pTR-2 |
---|
Cohort 2: Neoadjuvant MK-3475 | 13 | 2 | 13 |
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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
Intervention | Participants (Count of Participants) |
---|
| Partial Response | Progressive Disease | Stable Disease | Complete Response | Not Evaluable |
---|
Dose Escalation: Level 1 Dose | 0 | 1 | 1 | 0 | 1 |
,Dose Escalation: Level 2 Dose | 3 | 0 | 0 | 0 | 0 |
,Dose Expansion | 1 | 0 | 1 | 1 | 1 |
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Recommended Dose of Enzalutamide
"Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide.~Dose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or cisplatin will not be considered DLT.~7 consecutive missed doses (out of 21 doses) of enzalutamide in 21 days due to study drug related toxicity.~Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT.~Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity.~Discontinuation of a patient due to study drug related toxicity before completing cycle 1." (NCT02300610)
Timeframe: Up to 6 months
Intervention | mg (Number) |
---|
Dose Escalation | 160 |
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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
Intervention | months (Median) |
---|
Dose Escalation: Level 1 Dose | 3.81 |
Dose Escalation: Level 2 Dose | 14.63 |
Dose Expansion | 7.68 |
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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
Intervention | months (Median) |
---|
Dose Escalation: Level 1 Dose | 4.14 |
Dose Escalation: Level 2 Dose | 14.63 |
Dose Expansion | 10.03 |
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Overall Survival
2 year overall survival (NCT02325401)
Timeframe: 24 months
Intervention | participants (Number) |
---|
Metformin (2000mg) With Chemoradiation | 5 |
Metformin (2550mg) With Chemoradiation | 8 |
Metformin (3000mg) With Chemoradiation | 4 |
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Progression Free Survival
2-year progression free survival (NCT02325401)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Metformin (2000mg) With Chemoradiation | 6 |
Metformin (2550mg) With Chemoradiation | 8 |
Metformin (3000mg) With Chemoradiation | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Metformin (2000mg) With Chemoradiation | 6 |
Metformin (2550mg) With Chemoradiation | 7 |
Metformin (3000mg) With Chemoradiation | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Metformin (2000mg) With Chemoradiation | 6 |
Metformin (2550mg) With Chemoradiation | 8 |
Metformin (3000mg) With Chemoradiation | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Chemotherapy | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
| Disease Control Rate(DCR) | Complete Response(CR) | Partial Response (PR) | Stable Disease(SD) | Progressive Disease(PD) | Unknown |
---|
High Dose | 25 | 0 | 14 | 11 | 3 | 4 |
,Low Dose | 18 | 0 | 9 | 9 | 5 | 5 |
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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)
Intervention | proportion 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
Intervention | proportion 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
Intervention | months (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
Intervention | proportion 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)
Intervention | proportion 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
Intervention | months (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
Intervention | months (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)
Intervention | percentage of participants (Number) |
---|
All Patients Concurrently Randomized to Arms B and C | 78 |
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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.
Intervention | percentage 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
Intervention | percentage 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.
Intervention | percentage 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.
Intervention | mcg/mL (Mean) |
---|
Durvalumab Monotherapy | 625.3 |
Durvalumab + Tremelimumab | 506.1 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | NA |
Durvalumab + Tremelimumab | NA |
SoC Chemotherapy | 4.4 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | NA |
Durvalumab + Tremelimumab | NA |
SoC Chemotherapy | 4.4 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | NA |
Durvalumab + Tremelimumab | NA |
SoC Chemotherapy | 4.3 |
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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.
Intervention | mcg/mL (Mean) |
---|
Durvalumab + Tremelimumab | 4.9 |
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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.
Intervention | Participants (Count of Participants) |
---|
| ADA positive at any time | Treatment-emergent ADA positive | ADA positive at baseline and post-baseline | ADA positive at post-baseline only | ADA positive at baseline only | Treatment-boosted ADA | Persistent positive | Transient positive | nAb positive at any visit |
---|
Durvalumab + Tremelimumab | 14 | 8 | 1 | 8 | 5 | 0 | 9 | 0 | 1 |
,Durvalumab Monotherapy | 17 | 8 | 3 | 8 | 6 | 0 | 8 | 3 | 2 |
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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.
Intervention | microgram per milliliter (mcg/mL) (Mean) |
---|
| At Week 0: Pre-infusion | At Week 0: End of infusion | At Week 12: Pre-infusion | At Week 12: End of infusion | At Week 24: Pre-infusion | At Week 24: End of infusion | At follow-up Month 3 |
---|
Durvalumab + Tremelimumab | NA | 444.3 | 140.8 | 506.1 | 197.0 | 553.2 | 41.4 |
,Durvalumab Monotherapy | NA | 484.5 | 139.5 | 625.3 | 163.0 | 598.2 | 49.3 |
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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.
Intervention | mcg/mL (Mean) |
---|
| At Week 0: Pre-infusion | At Week 0: End of infusion | At Week 12: Pre-infusion | At Week 12: End of infusion | At follow-up Month 3 |
---|
Durvalumab + Tremelimumab | NA | 22.6 | 4.9 | 24.8 | 0.5 |
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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).
Intervention | percentage of participants (Number) |
---|
Durvalumab Monotherapy | 35.6 |
Durvalumab + Tremelimumab | 34.4 |
SoC Chemotherapy | 37.7 |
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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).
Intervention | months (Median) |
---|
Durvalumab + Tremelimumab | 3.9 |
SoC Chemotherapy | 5.4 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 10.6 |
Durvalumab + Tremelimumab | 9.4 |
SoC Chemotherapy | 10.5 |
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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.
Intervention | percentage of participants (Number) |
---|
Durvalumab Monotherapy | 27.0 |
Durvalumab + Tremelimumab | 20.4 |
SoC Chemotherapy | 14.9 |
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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.
Intervention | percentage of participants (Number) |
---|
Durvalumab Monotherapy | 22.5 |
Durvalumab + Tremelimumab | 19.8 |
SoC Chemotherapy | 13.8 |
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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.
Intervention | percentage of participants (Number) |
---|
Durvalumab Monotherapy | 32.3 |
Durvalumab + Tremelimumab | 25.8 |
SoC Chemotherapy | 14.3 |
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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.
Intervention | mcg/mL (Mean) |
---|
Durvalumab + Tremelimumab | 24.8 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 16.3 |
Durvalumab + Tremelimumab | 11.9 |
SoC Chemotherapy | 12.9 |
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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.
Intervention | Participants (Count of Participants) |
---|
| ADA positive at any time | Treatment-emergent ADA positive | ADA positive at baseline and post-baseline | ADA positive at post-baseline only | ADA positive at baseline only | Treatment-boosted ADA | Persistent positive | Transient positive | nAb positive at any visit |
---|
Durvalumab + Tremelimumab | 33 | 28 | 1 | 28 | 4 | 0 | 25 | 4 | 25 |
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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.
Intervention | mcg/mL (Mean) |
---|
Durvalumab Monotherapy | 139.5 |
Durvalumab + Tremelimumab | 140.8 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 12.7 |
Durvalumab + Tremelimumab | 10.9 |
SoC Chemotherapy | 10.4 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 9.3 |
Durvalumab + Tremelimumab | 9.8 |
SoC Chemotherapy | 10.1 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 16.3 |
Durvalumab + Tremelimumab | 11.9 |
SoC Chemotherapy | 12.9 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 14.6 |
Durvalumab + Tremelimumab | 10.9 |
SoC Chemotherapy | 12.3 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 4.7 |
Durvalumab + Tremelimumab | 3.9 |
SoC Chemotherapy | 5.4 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 3.6 |
Durvalumab + Tremelimumab | 2.8 |
SoC Chemotherapy | 5.5 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 12.3 |
Durvalumab + Tremelimumab | 11.2 |
SoC Chemotherapy | 11.8 |
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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).
Intervention | percentage of participants (Number) |
---|
Durvalumab Monotherapy | 26.5 |
Durvalumab + Tremelimumab | 25.3 |
SoC Chemotherapy | 33.6 |
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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).
Intervention | percentage of participants (Number) |
---|
Durvalumab Monotherapy | 22.2 |
Durvalumab + Tremelimumab | 24.7 |
SoC Chemotherapy | 30.1 |
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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).
Intervention | months (Median) |
---|
Durvalumab Monotherapy | 2.8 |
Durvalumab + Tremelimumab | 2.9 |
SoC Chemotherapy | 5.4 |
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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.
Intervention | months (Median) |
---|
| PD-L1-negative NSCLC analysis set | FAS |
---|
China: Durvalumab + Tremelimumab | 10.5 | 12.9 |
,China: SoC Chemotherapy | 6.1 | 6.1 |
,Global: Durvalumab + Tremelimumab | 10.2 | 11.1 |
,Global: SoC Chemotherapy | 4.9 | 4.9 |
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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.
Intervention | percentage of participants (Number) |
---|
| PD-L1-negative NSCLC analysis set | FAS |
---|
China: Durvalumab + Tremelimumab | 15.6 | 23.9 |
,China: SoC Chemotherapy | 11.3 | 16.6 |
,Global: Durvalumab + Tremelimumab | 18.2 | 20.2 |
,Global: SoC Chemotherapy | 12.1 | 14.9 |
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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.
Intervention | percentage of participants (Number) |
---|
| bTMB ≥20 mut/Mb analysis set | bTMB ≥16 mut/Mb analysis set | bTMB ≥12 mut/Mb analysis set |
---|
Global: Durvalumab + Tremelimumab | 25.6 | 22.0 | 21.6 |
,Global: SoC Chemotherapy | 7.0 | 12.3 | 13.8 |
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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
Intervention | microgram per milliliter (µg/mL) (Geometric Mean) |
---|
| Week 0: Pre-infusion | Week 0: End of infusion | Week 12: Pre-infusion | Week 12: End of infusion | Week 24: Pre-infusion | Follow-up Month 3 |
---|
China: Durvalumab + Tremelimumab | NA | 392.7 | 72.4 | 448.9 | 85.6 | 5.4 |
,Global: Durvalumab + Tremelimumab | NA | 418.6 | 77.5 | 434.3 | 108.8 | 8.8 |
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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.
Intervention | months (Median) |
---|
| FAS | PD-L1 TC ≥25% analysis set | PD-L1 TC ≥50% analysis set |
---|
China: Durvalumab + Tremelimumab | 20.0 | 36.6 | 36.6 |
,China: SoC Chemotherapy | 14.1 | 15.8 | 15.8 |
,Global: Durvalumab + Tremelimumab | 10.9 | 12.2 | 14.1 |
,Global: SoC Chemotherapy | 12.1 | 10.4 | 10.5 |
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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).
Intervention | months (Median) |
---|
China: Durvalumab + Tremelimumab | 15.0 |
China: SoC Chemotherapy | 11.7 |
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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
Intervention | µg/mL (Geometric Mean) |
---|
| Week 0: Pre-infusion | Week 0: End of infusion | Week 12: Pre-infusion | Week 12: End of infusion | Follow-up Month 3 |
---|
China: Durvalumab + Tremelimumab | NA | 18.4 | 3.3 | 23.2 | NA |
,Global: Durvalumab + Tremelimumab | NA | 20.3 | 3.4 | 20.8 | NA |
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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).
Intervention | months (Median) |
---|
| bTMB ≥20 mut/Mb analysis set | bTMB ≥16 mut/Mb analysis set | bTMB ≥12 mut/Mb analysis set |
---|
Global: Durvalumab + Tremelimumab | 10.6 | 10.9 | 9.9 |
,Global: SoC Chemotherapy | 8.6 | 10.5 | 9.0 |
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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).
Intervention | months (Median) |
---|
| bTMB ≥20 mut/Mb analysis set | bTMB ≥16 mut/Mb analysis set | bTMB ≥12 mut/Mb analysis set | tTMB ≥14 mut/Mb analysis set | tTMB ≥12 mut/Mb analysis set | tTMB ≥10 mut/Mb analysis set | tTMB ≥8 mut/Mb analysis set |
---|
Global: Durvalumab + Tremelimumab | 4.2 | 4.2 | 3.9 | 8.7 | 5.2 | 4.3 | 4.4 |
,Global: SoC Chemotherapy | 5.1 | 5.5 | 5.1 | 5.8 | 5.8 | 5.1 | 5.0 |
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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.
Intervention | months (Median) |
---|
| PD-L1-negative NSCLC analysis set | FAS |
---|
China: Durvalumab + Tremelimumab | 13.8 | 15.5 |
,China: SoC Chemotherapy | 10.3 | 12.9 |
,Global: Durvalumab + Tremelimumab | 9.1 | 9.4 |
,Global: SoC Chemotherapy | 12.4 | 10.4 |
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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.
Intervention | months (Median) |
---|
| PD-L1-negative NSCLC analysis set | FAS | PD-L1 TC ≥25% analysis set | PD-L1 TC ≥50% analysis set |
---|
China: Durvalumab + Tremelimumab | 5.1 | 4.2 | 6.8 | 6.8 |
,China: SoC Chemotherapy | 6.0 | 6.0 | 5.7 | 5.7 |
,Global: Durvalumab + Tremelimumab | 4.1 | 4.0 | 4.2 | 4.6 |
,Global: SoC Chemotherapy | 5.6 | 5.6 | 5.4 | 5.4 |
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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).
Intervention | months (Median) |
---|
| bTMB ≥16 mut/Mb analysis set | bTMB ≥12 mut/Mb analysis set | PD-L1 negative analysis set | bTMB <20 mut/Mb analysis set | bTMB non-evaluable analysis set | tTMB ≥14 mut/Mb analysis set | tTMB ≥12 mut/Mb analysis set | tTMB ≥10 mut/Mb analysis set | tTMB ≥8 mut/Mb analysis set |
---|
Global: Durvalumab + Tremelimumab | 12.1 | 10.9 | 11.1 | 9.9 | 9.3 | 17.5 | 11.1 | 11.1 | 11.0 |
,Global: SoC Chemotherapy | 11.9 | 10.3 | 12.5 | 11.5 | 10.4 | 10.6 | 13.9 | 10.6 | 10.2 |
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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
Intervention | percentage of participants (Number) |
---|
| Month 12: bTMB ≥20 mut/Mb analysis set | Month 12: bTMB ≥16 mut/Mb analysis set | Month 12: bTMB ≥12 mut/Mb analysis set | Month 18: bTMB ≥20 mut/Mb analysis set | Month 18: bTMB ≥16 mut/Mb analysis set | Month 18: bTMB ≥12 mut/Mb analysis set | Month 24: bTMB ≥20 mut/Mb analysis set | Month 24: bTMB ≥16 mut/Mb analysis set | Month 24: bTMB ≥12 mut/Mb analysis set |
---|
Global: Durvalumab + Tremelimumab | 49.3 | 50.5 | 46.9 | 36.2 | 35.5 | 29.4 | 26.1 | 24.0 | 21.3 |
,Global: SoC Chemotherapy | 40.8 | 48.9 | 44.6 | 20.4 | 28.5 | 27.8 | 13.6 | 18.2 | 19.0 |
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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
Intervention | percentage of participants (Number) |
---|
| Month 12: PD-L1-negative NSCLC analysis set | Month 12: FAS | Month 18: PD-L1-negative NSCLC analysis set | Month 18: FAS | Month 24: PD-L1-negative NSCLC analysis set | Month 24: FAS |
---|
China: Durvalumab + Tremelimumab | 68.0 | 72.8 | 44.0 | 54.6 | 36.0 | 44.2 |
,China: SoC Chemotherapy | 46.4 | 53.1 | 39.3 | 41.8 | 17.9 | 30.4 |
,Global: Durvalumab + Tremelimumab | 47.8 | 47.7 | 34.1 | 34.8 | 22.1 | 25.7 |
,Global: SoC Chemotherapy | 52.8 | 50.0 | 34.5 | 34.6 | 22.3 | 23.4 |
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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.
Intervention | percentage of participants (Number) |
---|
| PD-L1-negative NSCLC analysis set | FAS | PD-L1 TC ≥25% analysis set | PD-L1 TC ≥50% analysis set |
---|
China: Durvalumab + Tremelimumab | 23.1 | 35.9 | 54.8 | 60.0 |
,China: SoC Chemotherapy | 41.4 | 39.0 | 40.6 | 46.4 |
,Global: Durvalumab + Tremelimumab | 23.1 | 25.9 | 35.2 | 37.4 |
,Global: SoC Chemotherapy | 38.8 | 41.7 | 43.9 | 44.0 |
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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).
Intervention | percentage of participants (Number) |
---|
| bTMB ≥20 mut/Mb analysis set | bTMB ≥16 mut/Mb analysis set | bTMB ≥12 mut/Mb analysis set | tTMB ≥14 mut/Mb analysis set | tTMB ≥12 mut/Mb analysis set | tTMB ≥10 mut/Mb analysis set | tTMB ≥8 mut/Mb analysis set |
---|
Global: Durvalumab + Tremelimumab | 27.5 | 31.2 | 28.7 | 61.3 | 42.6 | 37.7 | 36.7 |
,Global: SoC Chemotherapy | 43.3 | 46.1 | 42.0 | 44.7 | 41.8 | 42.5 | 41.2 |
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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.
Intervention | Participants (Count of Participants) |
---|
| ADA positive at any visit (ADA prevalence) | Treatment-emergent ADA positive (ADA incidence) | Treatment-boosted ADA | Treatment-induced ADA (positive post-baseline only) | ADA positive post-baseline and positive at baseline | Persistent positive | Transient positive | nAb positive at any visit | ADA positive at baseline and not detected post-baseline |
---|
China: Durvalumab + Tremelimumab | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
,Global: Durvalumab + Tremelimumab | 26 | 12 | 0 | 12 | 1 | 11 | 2 | 3 | 13 |
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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.
Intervention | Participants (Count of Participants) |
---|
| ADA positive at any visit (ADA prevalence) | Treatment-emergent ADA positive (ADA incidence) | Treatment-boosted ADA | Treatment-induced ADA (positive post-baseline only) | ADA positive post-baseline and positive at baseline | Persistent positive | Transient positive | nAb positive at any visit | ADA positive at baseline and not detected post-baseline |
---|
China: Durvalumab + Tremelimumab | 2 | 1 | 0 | 1 | 1 | 0 | 2 | 0 | 0 |
,Global: Durvalumab + Tremelimumab | 49 | 37 | 1 | 36 | 4 | 29 | 11 | 33 | 9 |
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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).
Intervention | months (Median) |
---|
| bTMB ≥20 mut/Mb analysis set | bTMB ≥16 mut/Mb analysis set | bTMB ≥12 mut/Mb analysis set |
---|
Global: Durvalumab + Tremelimumab | 11.6 | 10.6 | 11.5 |
,Global: SoC Chemotherapy | 4.2 | 4.3 | 4.3 |
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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).
Intervention | months (Median) |
---|
Global: Durvalumab + Tremelimumab | 11.7 |
Global: SoC Chemotherapy | 9.1 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Hypotension | Multi-organ failure | Cardiac arrest | Neutropenia | Respiratory failure | Pulmonary embolism | Thrombocytopenia | Creatinine Increased | Leukocytosis | Acute kidney injury | Vomiting | Urinary tract infection |
---|
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) | 0 | 0 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 0 | 1 |
,Arm B (Gemcitabine Hydrochloride, Cisplatin) | 1 | 1 | 0 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 1 | 0 |
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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
Intervention | Months (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
Intervention | Months (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
Intervention | percentage 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)
Intervention | Participants (Count of Participants) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 11 |
Arm 2: Nab-Paclitaxel (A) + CRT | 28 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 6 |
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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)
Intervention | percentage of participants (Number) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 87.50 |
Arm 2: Nab-Paclitaxel (A) + CRT | 51.81 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 69.23 |
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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)
Intervention | percentage of participants (Number) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 87.50 |
Arm 2: Nab-Paclitaxel (A) + CRT | 62.50 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 76.92 |
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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)
Intervention | percentage of participants (Number) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 97.44 |
Arm 2: Nab-Paclitaxel (A) + CRT | 69.63 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 84.62 |
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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)
Intervention | percentage of participants (Number) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 87.43 |
Arm 2: Nab-Paclitaxel (A) + CRT | 54.89 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 69.23 |
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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)
Intervention | percentage of participants (Number) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 92.50 |
Arm 2: Nab-Paclitaxel (A) + CRT | 67.50 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 76.92 |
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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)
Intervention | Participants (Count of Participants) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction | 23 |
Arm 2: Nab-Paclitaxel (A) Induction | 17 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction | 4 |
Arm 1 CRT: Cisplatin + Radiation Therapy | 37 |
Arm 1 & 2 ERT: Cetuximab + Radiation Therapy | 35 |
Arm 3 CR: Cisplatin + Radiation Therapy | 4 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Complete response | Partial response |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 2 | 22 |
,Arm 2: Nab-Paclitaxel (A) + CRT | 1 | 20 |
,Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 1 | 13 |
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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)
Intervention | score on a scale (Mean) |
---|
| Baseline | End of treatment |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 2.02 | 1.98 |
,Arm 2: Nab-Paclitaxel (A) + CRT | 1.86 | 1.82 |
,Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 2.07 | 2.00 |
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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)
Intervention | score on a scale (Mean) |
---|
| Baseline | End of treatment |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 0.19 | 1.55 |
,Arm 2: Nab-Paclitaxel (A) + CRT | 0.38 | 0.91 |
,Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 0.27 | 1.54 |
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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)
Intervention | Participants (Count of Participants) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 28 |
Arm 2: Nab-Paclitaxel (A) + CRT | 8 |
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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)
Intervention | percentage of particpants (Number) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 100 |
Arm 2: Nab-Paclitaxel (A) + CRT | 87.50 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 92.31 |
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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)
Intervention | Participants (Count of Participants) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction | 23 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction | 4 |
Arm 1 CRT: Cisplatin + Radiation Therapy | 37 |
Arm 3 CR: Cisplatin + Radiation Therapy | 4 |
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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)
Intervention | Participants (Count of Participants) |
---|
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 9 |
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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)
Intervention | Participants (Count of Participants) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 18 |
Arm 2: Nab-Paclitaxel (A) + CRT | 14 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 3 |
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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)
Intervention | Participants (Count of Participants) |
---|
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT | 11 |
Arm 2: Nab-Paclitaxel (A) + CRT | 14 |
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT | 7 |
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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)
Intervention | Participants (Count of Participants) |
---|
Single Arm | 47 |
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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)
Intervention | Participants (Count of Participants) |
---|
Single Arm | 57 |
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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
Intervention | Participants (Count of Participants) |
---|
| ALT OR AST >3XULN | ALT OR AST >5XULN | ALT OR AST >10XULN | ALT OR AST >20XULN | TOTAL BILIRUBIN >2XULN | Concurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 1 day | Concurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 30 days |
---|
Nivolumab+Ipilimumab+Chemotherapy | 2 | 2 | 1 | 1 | 0 | 0 | 0 |
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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)
Intervention | Months (Median) |
---|
Nivolumab+Ipilimumab | 5.19 |
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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)
Intervention | Months (Median) |
---|
Nivolumab+Ipilimumab+Chemotherapy | 19.35 |
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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)
Intervention | Months (Median) |
---|
Nivolumab+Ipilimumab | 20.83 |
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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
Intervention | Percentage of participants (Number) |
---|
Nivolumab+Ipilimumab | 32.3 |
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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
Intervention | Participants (Count of Participants) |
---|
Nivolumab+Ipilimumab+Chemotherapy | 1 |
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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
Intervention | Percentage of participants (Number) |
---|
Nivolumab+Ipilimumab+Chemotherapy | 47.2 |
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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)
Intervention | Months (Median) |
---|
| High TMB (>=10 Mutations/MB) | Low TMB (<10 Mutations/MB) |
---|
Nivolumab+Ipilimumab | 10.84 | 2.79 |
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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
Intervention | Participants (Count of Participants) |
---|
| TSH > ULN | TSH > ULN with TSH <= ULN at baseline | TSH > ULN with at least one FT3/FT4 test value < LLN | TSH > ULN with all other FT3/FT4 test values ≥ LLN | TSH > ULN with FT3/FT4 test missing | TSH < LLN | TSH < LLN with TSH >= LLN at baseline | TSH < LLN with at least one FT3/FT4 test value > ULN | TSH < LLN with all other FT3/FT4 test values <= ULN | TSH < LLN with FT3/Ft4 test missing |
---|
Nivolumab+Ipilimumab+Chemotherapy | 10 | 7 | 8 | 1 | 1 | 13 | 12 | 7 | 6 | 0 |
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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)
Intervention | Months (Median) |
---|
| PD-L1 ≥1% | PD-L1 <1% |
---|
Nivolumab+Ipilimumab | 6.80 | 2.92 |
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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)
Intervention | Months (Median) |
---|
| High TMB (>=10 Mutations/MB) | Low TMB (<10 Mutations/MB) |
---|
Nivolumab+Ipilimumab | 47.31 | 11.33 |
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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)
Intervention | Months (Median) |
---|
| PD-L1 ≥1% | PD-L1 <1% |
---|
Nivolumab+Ipilimumab | 26.51 | 13.70 |
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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
Intervention | Percentage of participants (Number) |
---|
| High TMB (>=10 Mutations/MB) | Low TMB (<10 Mutations/MB) |
---|
Nivolumab+Ipilimumab | 52.1 | 16.0 |
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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)
Intervention | Percentage of participants (Number) |
---|
| PD-L1 ≥1% | PD-L1 <1% |
---|
Nivolumab+Ipilimumab | 41.3 | 14.9 |
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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
Intervention | Percentage of participants (Number) |
---|
| PD-L1 ≥1% | PD-L1 <1% |
---|
Nivolumab+Ipilimumab | 44.2 | 17.1 |
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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
Intervention | Participants (Count of Participants) |
---|
| Adverse Events (AEs) | Serious Adverse Events (SAEs) | Deaths due to Disease progression | Deaths due to Study drug toxicity | Deaths due to unknown causes | Deaths due to other causes |
---|
Nivolumab+Ipilimumab+Chemotherapy | 36 | 26 | 9 | 0 | 1 | 6 |
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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)
Intervention | Months (Median) |
---|
Nivolumab+Ipilimumab+Chemotherapy | 10.81 |
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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
Intervention | Participants (Count of Participants) |
---|
Drug: ADI-PEG 20 Plus Pem Platinum | 12 |
Drug: Placebo Plus Pem Platinum | 12 |
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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
Intervention | months (Median) |
---|
Drug: ADI-PEG 20 Plus Pem Platinum | 6.24 |
Drug: Placebo Plus Pem Platinum | 5.65 |
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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
Intervention | months (Median) |
---|
Drug: ADI-PEG 20 Plus Pem Platinum | 9.30 |
Drug: Placebo Plus Pem Platinum | 7.66 |
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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
Intervention | months (Median) |
---|
Drug: ADI-PEG 20 Plus Pem Platinum | 9.82 |
Drug: Placebo Plus Pem Platinum | 7.49 |
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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)
Intervention | Months (Median) |
---|
Nivolumab + Ipilimumab | 17.74 |
EXTREME Regimen | 14.59 |
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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
Intervention | Percent (Number) |
---|
| All randomized participants | Randomized PD-L1 CPS >= 20 participants |
---|
EXTREME Regimen | 37.1 | 35.4 |
,Nivolumab + Ipilimumab | 24.2 | 34.1 |
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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)
Intervention | Months (Median) |
---|
Nivolumab + Ipilimumab | 15.67 |
EXTREME Regimen | 13.24 |
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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)
Intervention | Months (Median) |
---|
| All randomized participants | Randomized PD-L1 CPS >= 20 participants |
---|
EXTREME Regimen | 5.88 | 6.97 |
,Nivolumab + Ipilimumab | 16.59 | 33.51 |
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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)
Intervention | Months (Median) |
---|
Nivolumab + Ipilimumab | 17.58 |
EXTREME Regimen | 14.59 |
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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)
Intervention | Months (Median) |
---|
| Randomized participants | Randomized PD-L1 CPS >= 20 participants |
---|
EXTREME Regimen | 6.77 | 6.97 |
,Nivolumab + Ipilimumab | 3.29 | 5.39 |
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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)
Intervention | Months (Median) |
---|
Nivolumab + Ipilimumab | 13.90 |
EXTREME Regimen | 13.50 |
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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)
Intervention | Months (Median) |
---|
Nivolumab + Ipilimumab | 13.90 |
EXTREME Regimen | 13.50 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
Rucaparib | 0.6 |
Chemotherapy | 0.4 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
Rucaparib | 0.5 |
Chemotherapy | 0.3 |
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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.
Intervention | Months (Median) |
---|
Rucaparib | 7.4 |
Chemotherapy | 5.7 |
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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.
Intervention | Months (Median) |
---|
Rucaparib | 7.4 |
Chemotherapy | 5.7 |
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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.
Intervention | percentage of patients (Number) |
---|
Rucaparib | 47.8 |
Chemotherapy | 40.5 |
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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.
Intervention | percentage of participants (Number) |
---|
Rucaparib | 37.9 |
Chemotherapy | 30.2 |
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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.
Intervention | percentage of participants (Number) |
---|
Rucaparib | 40.3 |
Chemotherapy | 32.3 |
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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.
Intervention | months (Median) |
---|
Rucaparib | 9.4 |
Chemotherapy | 7.2 |
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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.
Intervention | months (Median) |
---|
Rucaparib | 9.4 |
Chemotherapy | 7.2 |
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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.
Intervention | Months (Median) |
---|
Rucaparib | 19.4 |
Chemotherapy | 25.4 |
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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.
Intervention | Months (Median) |
---|
Rucaparib | 21.1 |
Chemotherapy | 26.2 |
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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.
Intervention | percentage of patients (Number) |
---|
Rucaparib | 50.7 |
Chemotherapy | 43.6 |
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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
Intervention | µg/mL (Geometric Mean) |
---|
Part A Combined Cohort 1 | 80.0 |
Part A Combined Cohort 2 | 73.8 |
Part A Combined Cohorts 1 and 2 | 76.2 |
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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
Intervention | Participants (Count of Participants) |
---|
Part A Cohort 1: Epacadostat 25 mg | 0 |
Part A Cohort 1: Epacadostat 100 mg | 1 |
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | 0 |
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 1 |
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed | 0 |
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed | 3 |
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel | 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
Intervention | nM (Geometric Mean) |
---|
| Day 5 |
---|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 106.0 |
,Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | NA |
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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
Intervention | hours (Median) |
---|
| Day 1 | Day 5 | Day 12 |
---|
Part A Cohort 1: Epacadostat 100 mg | 2.00 | 2.00 | 2.00 |
,Part A Cohort 1: Epacadostat 25 mg | 2.00 | 2.00 | 2.00 |
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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
Intervention | hours (Median) |
---|
| Day 5 |
---|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 2.00 |
,Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | 2.00 |
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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
Intervention | hours (Geometric Mean) |
---|
| Day 1 | Day 5 | Day 12 |
---|
Part A Cohort 1: Epacadostat 100 mg | 2.55 | 2.82 | 2.43 |
,Part A Cohort 1: Epacadostat 25 mg | 3.94 | 3.01 | 4.27 |
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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
Intervention | hours (Geometric Mean) |
---|
| Day 5 |
---|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 3.77 |
,Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | 2.62 |
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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
Intervention | nM (Geometric Mean) |
---|
| Day 1 | Day 5 | Day 12 |
---|
Part A Cohort 1: Epacadostat 100 mg | 1060 | 1100 | 1200 |
,Part A Cohort 1: Epacadostat 25 mg | 327 | 269 | 294 |
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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
Intervention | Participants (Count of Participants) |
---|
Part A Cohort 1: Epacadostat 25 mg | 0 |
Part A Cohort 1: Epacadostat 100 mg | 0 |
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | 0 |
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 1 |
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed | 1 |
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed | 2 |
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel | 2 |
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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
Intervention | nM•hour (Geometric Mean) |
---|
| Day 1 | Day 5 | Day 12 |
---|
Part A Cohort 1: Epacadostat 100 mg | 4250 | 4670 | 4710 |
,Part A Cohort 1: Epacadostat 25 mg | 855 | 1060 | 1020 |
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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
Intervention | µg/mL (Geometric Mean) |
---|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed | 73.8 |
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed | 64.3 |
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel | 65.3 |
Part B Combined Cohorts 1, 2, and 3 | 68.0 |
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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
Intervention | nM•hour (Geometric Mean) |
---|
| Day 5 |
---|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 3950 |
,Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | 1260 |
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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
Intervention | Participants (Count of Participants) |
---|
Part A Cohort 1: Epacadostat 25 mg | 3 |
Part A Cohort 1: Epacadostat 100 mg | 2 |
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | 3 |
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 6 |
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed | 7 |
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed | 6 |
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel | 6 |
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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
Intervention | µg/mL (Geometric Mean) |
---|
| Cycle 1 | Cycle 2 | Cycle 4 | Cycle 6 | Cycle 8 |
---|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed | NA | 16.6 | 37.8 | 53.8 | 65.4 |
,Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed | NA | 17.4 | 28.1 | 40.5 | 52.7 |
,Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel | NA | 8.69 | 25.4 | 21.5 | 34.5 |
,Part B Combined Cohorts 1, 2, and 3 | NA | 13.3 | 31.5 | 38.6 | 50.3 |
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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
Intervention | nM (Geometric Mean) |
---|
| Day 1 | Day 5 | Day 12 |
---|
Part A Cohort 1: Epacadostat 100 mg | NA | 87.7 | 95.4 |
,Part A Cohort 1: Epacadostat 25 mg | NA | NA | NA |
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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
Intervention | nM (Geometric Mean) |
---|
| Day 5 |
---|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab | 852 |
,Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab | 371 |
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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
Intervention | µg/mL (Geometric Mean) |
---|
| Cycle 1 | Cycle 2 | Cycle 4 | Cycle 6 | Cycle 8 |
---|
Part A Combined Cohort 1 | NA | 17.3 | 24.5 | 28.5 | 38.2 |
,Part A Combined Cohort 2 | NA | 17.9 | 41.8 | 51.0 | 47.9 |
,Part A Combined Cohorts 1 And 2 | NA | 17.6 | 35.0 | 39.8 | 45.2 |
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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
Intervention | h*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)
Intervention | Participants (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)
Intervention | Days (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
Intervention | Participants (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)
Intervention | percentage 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
Intervention | Days (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)
Intervention | Days (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
Intervention | ml/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
Intervention | Days (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
Intervention | ug/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
Intervention | hours (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)
Intervention | Days (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
Intervention | L (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.
Intervention | Participants (Count of Participants) |
---|
| Patients with at least one event | Endocrine disorders: Adrenal insufficiency | Endocrine disorders: Hyperthyroidism | Metabolism and nutrition disorders: Hyponatraemia |
---|
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab | 1 | 0 | 0 | 1 |
,Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab | 1 | 1 | 0 | 0 |
,Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab | 1 | 0 | 1 | 0 |
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Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)
"Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D).~ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR." (NCT02983045)
Timeframe: Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.
Intervention | Participants (Count of Participants) |
---|
Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w | 64 |
Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab | 3 |
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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.
Intervention | Participants (Count of Participants) |
---|
| At least 1 DLT | Metabolism and Nutrition Disorders: Acidosis | Metabolism and Nutrition Disorders: Hyperglycaemia | Vascular Disorders: Hypotension |
---|
Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w | 0 | 0 | 0 | 0 |
,Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w | 0 | 0 | 0 | 0 |
,Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w | 0 | 0 | 0 | 0 |
,Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w | 0 | 0 | 0 | 0 |
,Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w | 2 | 1 | 1 | 1 |
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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
Intervention | gram (Mean) |
---|
Phase 1: Group 1 | 0.42 |
Phase 1: Group II | 1.090 |
Phase 2: Group III | 1.255 |
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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
Intervention | score on a scale (Mean) |
---|
Phase 1: Group 1 | 1 |
Phase 1: Group II | 1.33 |
Phase 2: Group III | 1.29 |
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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
Intervention | days (Mean) |
---|
Phase 1: Group 1 | 22 |
Phase 1: Group II | 18 |
Phase 2: Group III | 37.4 |
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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
Intervention | gram (Mean) |
---|
Phase 1: Group 1 | 1.487 |
Phase 1: Group II | 2.387 |
Phase 2: Group III | 2.115 |
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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
Intervention | Participants (Count of Participants) |
---|
Phase 1: Group 1 | 1 |
Phase 1: Group II | 1 |
Phase 2: Group III | 10 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 11.8 |
Platinum-based SoC | 10.9 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 5.7 |
Platinum-based SoC | 5.5 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 5.6 |
Platinum-based SoC | 4.5 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 5.5 |
Platinum-based SoC | 5.6 |
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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]
Intervention | months (Median) |
---|
Durvalumab | 14.6 |
Platinum-based SoC | 12.8 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 14.9 |
Platinum-based SoC | 14.9 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 14.6 |
Platinum-based SoC | 11.8 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 14.6 |
Platinum-based SoC | 15.0 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 36.9 |
Platinum-based SoC | 32.6 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 37.0 |
Platinum-based SoC | 27.0 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 34.7 |
Platinum-based SoC | 32.8 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 34.6 |
Platinum-based SoC | 27.2 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 44.3 |
Platinum-based SoC | 42.2 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 43.2 |
Platinum-based SoC | 34.9 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 43.0 |
Platinum-based SoC | 41.4 |
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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.
Intervention | percentage of participants (Number) |
---|
Durvalumab | 42.5 |
Platinum-based SoC | 34.2 |
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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)
Intervention | percentage of participants (Number) |
---|
Durvalumab | 44.0 |
Platinum-based SoC | 43.7 |
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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)
Intervention | percentage of participants (Number) |
---|
Durvalumab | 42.1 |
Platinum-based SoC | 40.7 |
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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)
Intervention | percentage of participants (Number) |
---|
Durvalumab | 38.5 |
Platinum-based SoC | 40.2 |
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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)
Intervention | percentage of participants (Number) |
---|
Durvalumab | 37.6 |
Platinum-based SoC | 37.4 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 11.9 |
Platinum-based SoC | 4.2 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 12.2 |
Platinum-based SoC | 4.2 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 12.2 |
Platinum-based SoC | 4.2 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 11.6 |
Platinum-based SoC | 4.2 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 26.5 |
Platinum-based SoC | 14.5 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 26.1 |
Platinum-based SoC | 11.7 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 24.1 |
Platinum-based SoC | 16.4 |
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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
Intervention | percentage of participants (Number) |
---|
Durvalumab | 25.5 |
Platinum-based SoC | 13.3 |
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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)
Intervention | months (Median) |
---|
| Cough | Dyspnea | Chest pain |
---|
Durvalumab | 7.5 | 2.8 | 9.0 |
,Platinum-based SoC | 6.6 | 3.6 | 6.4 |
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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)
Intervention | months (Median) |
---|
| Cough | Dyspnea | Chest pain |
---|
Durvalumab | 9.2 | 3.6 | 9.8 |
,Platinum-based SoC | 8.2 | 3.6 | 6.6 |
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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)
Intervention | months (Median) |
---|
| Global health status | Physical functioning | Appetite loss | Fatigue |
---|
Durvalumab | 7.4 | 7.4 | 9.3 | 5.5 |
,Platinum-based SoC | 5.5 | 4.7 | 3.7 | 1.8 |
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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)
Intervention | months (Median) |
---|
| Global health status | Physical functioning | Appetite loss | Fatigue |
---|
Durvalumab | 7.3 | 7.4 | 9.2 | 4.9 |
,Platinum-based SoC | 3.8 | 3.8 | 3.6 | 1.8 |
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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
Intervention | percentage of participants (Number) |
---|
| Treatment-emergent ADA positive | Treatment-boosted ADA | Persistently positive | Transiently positive |
---|
Durvalumab | 0.8 | 0.4 | 0 | 0.8 |
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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
Intervention | percentage of participants (Number) |
---|
| Treatment-emergent ADA positive | Treatment-boosted ADA | Persistently positive | Transiently positive |
---|
Durvalumab | 1.0 | 0.5 | 0 | 1.0 |
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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
Intervention | scores on a scale (Mean) |
---|
| Global health status | Physical functioning | Fatigue | Appetite loss |
---|
Durvalumab | -0.7 | -3.3 | 1.4 | -1.1 |
,Platinum-based SoC | -7.4 | -6.1 | 7.2 | 9.1 |
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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
Intervention | scores on a scale (Mean) |
---|
| Cough | Dyspnea | Chest pain |
---|
Durvalumab | -6.6 | 2.9 | -0.7 |
,Platinum-based SoC | -8.6 | 3.9 | -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
Intervention | scores on a scale (Mean) |
---|
| Global health status | Physical functioning | Fatigue | Appetite loss |
---|
Durvalumab | -1.4 | -3.9 | 2.2 | -0.2 |
,Platinum-based SoC | -7.3 | -6.0 | 7.7 | 9.8 |
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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
Intervention | scores on a scale (Mean) |
---|
| Cough | Dyspnea | Chest pain |
---|
Durvalumab | -6.4 | 2.4 | -1.0 |
,Platinum-based SoC | -7.9 | 4.1 | -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)
Intervention | months (Median) |
---|
Durvalumab | 11.3 |
Platinum-based SoC | 9.3 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 5.4 |
Platinum-based SoC | 4.8 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 12.0 |
Platinum-based SoC | 10.9 |
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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)
Intervention | months (Median) |
---|
Durvalumab | 11.3 |
Platinum-based SoC | 8.8 |
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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
Intervention | Score on a scale (Least Squares Mean) |
---|
Pembrolizumab + Cisplatin + CRT | 1.95 |
Placebo + Cisplatin + CRT | 6.08 |
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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
Intervention | Score 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
Intervention | Months (Median) |
---|
Pembrolizumab + Cisplatin + CRT | NA |
Placebo + Cisplatin + CRT | 46.6 |
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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)
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Cisplatin + CRT | 164 |
Placebo + Cisplatin + CRT | 132 |
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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
Intervention | Score on a scale (Least Squares Mean) |
---|
| Swallowing | Speech | Pain |
---|
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
Intervention | Months (Median) |
---|
Pembrolizumab + Cisplatin + CRT | NA |
Placebo + Cisplatin + CRT | NA |
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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)
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Cisplatin + CRT | 398 |
Placebo + Cisplatin + CRT | 397 |
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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
Intervention | Participants (Count of Participants) |
---|
Radiation Therapy | 0 |
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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
Intervention | percentage of patients (Number) |
---|
Radiation Therapy | 89 |
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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
Intervention | percentage of patients (Number) |
---|
Radiation Therapy | 79 |
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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
Intervention | Participants (Count of Participants) |
---|
Radiation Therapy | 31 |
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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
Intervention | percentage of patients (Number) |
---|
| Locoregional recurrence | Distant metastasis |
---|
Radiation Therapy | 14 | 14 |
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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
Intervention | score on a scale (Mean) |
---|
| EORTC QLQ30 global | EORTC QLQ30 physical fcn | EORTC QLQ30 role fcn | EORTC QLQ30 emotional fcn | EORTC QLQ30 cognitive fcn | EORTC QLQ30 social fcn | EORTC HN35 dry mouth | EORTC HN35 sticky saliva | EORTC HN35 senses | EORTC HN35 pain | EORTC HN35 speech | Composite MDADI |
---|
Total Cohort 12 Month | 85.9 | 93.0 | 95.3 | 88.2 | 90.7 | 90.3 | 38.0 | 27.1 | 15.9 | 7.9 | 9.8 | 84.9 |
,Total Cohort 3 Month | 76.9 | 87.4 | 82.5 | 87.7 | 89.5 | 85.1 | 59.0 | 38.0 | 25.7 | 16.5 | 13.4 | 79.6 |
,Total Cohort 6 Month | 79.2 | 90.3 | 85.6 | 82.9 | 86.4 | 85.6 | 47.7 | 27.3 | 20.1 | 14.2 | 19.2 | 76.9 |
,Total Cohort Baseline | 71.4 | 90.3 | 81.9 | 78.0 | 90.0 | 85.2 | 14.4 | 15.7 | 6.7 | 24.4 | 18.4 | 81.3 |
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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).
Intervention | Participants (Count of Participants) |
---|
| ADA positive at any visit (ADA prevalence) | Treatment-emergent ADA positive (ADA incidence) | Treatment-boosted ADA | Treatment-induced ADA (ADA positive post-baseline only) | ADA positive at baseline only | ADA positive post-baseline and positive at baseline | Persistently positive | Transiently positive | nAb positive at any visit |
---|
D + SoC | 33 | 19 | 1 | 18 | 13 | 2 | 7 | 13 | 3 |
,T + D + SoC | 42 | 29 | 2 | 27 | 8 | 7 | 8 | 26 | 3 |
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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.
Intervention | μg/mL (Geometric Mean) |
---|
| Week 0 | Week 3 | Week 12 | Follow-up (3 months) |
---|
T + D + SoC | 23.17 | 4.16 | 7.82 | 0.86 |
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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).
Intervention | months (Median) |
---|
| QLQ-LC13 Cough | QLQ-LC13 Hemoptysis | QLQ-LC13 Dyspnea | QLQ-LC13 Pain in Chest | QLQ-LC13 Pain in Arm or Shoulder | QLQ-LC13 Pain in Other Parts |
---|
D + SoC | 11.0 | 14.0 | 5.0 | 9.5 | 8.9 | 8.9 |
,SoC Alone | 8.8 | 11.4 | 3.6 | 8.6 | 8.8 | 5.8 |
,T + D + SoC | 9.7 | 17.8 | 5.4 | 10.0 | 8.9 | 9.7 |
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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.
Intervention | micrograms/milliliter (μg/mL) (Geometric Mean) |
---|
| Week 0 | Week 3 | Week 12 | Follow-up (3 months) |
---|
D + SoC | 505.01 | 91.53 | 212.11 | 16.06 |
,T + D + SoC | 418.80 | 82.08 | 195.62 | 13.42 |
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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).
Intervention | months (Median) |
---|
T + D + SoC | 7.4 |
D + SoC | 6.0 |
SoC Alone | 4.2 |
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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).
Intervention | Participants (Count of Participants) |
---|
| ADA positive at any visit (ADA prevalence) | Treatment-emergent ADA positive (ADA incidence) | Treatment-boosted ADA | Treatment-induced ADA (ADA positive post-baseline only) | ADA positive at baseline only | ADA positive post-baseline and positive at baseline | Persistently positive | Transiently positive | nAb positive at any visit |
---|
T + D + SoC | 44 | 38 | 3 | 35 | 4 | 5 | 22 | 18 | 31 |
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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).
Intervention | months (Median) |
---|
T + D + SoC | 10.4 |
D + SoC | 10.2 |
SoC Alone | 9.4 |
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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).
Intervention | months (Median) |
---|
D + SoC | 5.5 |
SoC Alone | 4.8 |
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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.
Intervention | months (Median) |
---|
T + D + SoC | 6.2 |
D + SoC | 5.5 |
SoC Alone | 4.8 |
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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).
Intervention | months (Median) |
---|
D + SoC | 13.3 |
SoC Alone | 11.7 |
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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).
Intervention | months (Median) |
---|
T + D + SoC | 14.0 |
D + SoC | 13.3 |
SoC Alone | 11.7 |
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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).
Intervention | percentage of patients (Number) |
---|
T + D + SoC | 46.3 |
D + SoC | 48.5 |
SoC Alone | 33.4 |
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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)
Intervention | Months (Median) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | NA |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 18.1 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | NA |
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 15.1 |
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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)
Intervention | Participants (Count of Participants) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 0 |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 1 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 0 |
Phase 1b Lead-in: Avelumab 1200mg+Gemcitabine/Cisplatin | 1 |
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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)
Intervention | Months (Median) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | NA |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 9.8 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | NA |
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 5.4 |
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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)
Intervention | Months (Median) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 2.8 |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 1.4 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 1.3 |
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 1.5 |
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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)
Intervention | Participants (Count of Participants) |
---|
| ALANINE AMINOTRANSFERASE INCREASED | ALKALINE PHOSPHATASE INCREASED | ASPARTATE AMINOTRANSFERASE INCREASED | BLOOD BILIRUBIN INCREASED | CPK INCREASED | CREATININE INCREASED | GGT INCREASED | HYPERGLYCEMIA | HYPERKALEMIA | HYPOKALEMIA | HYPONATREMIA | LIPASE INCREASED | SERUM AMYLASE INCREASED | HYPOPHOSPHATEMIA | HYPOMAGNESEMIA | HYPOCALCEMIA | HYPERTRIGLYCERIDEMIA | HYPERNATREMIA | HYPERMAGNESEMIA | HYPERCALCEMIA | ANEMIA | LYMPHOCYTE COUNT DECREASED | LYMPHOCYTE COUNT INCREASED | NEUTROPHIL COUNT DECREASED | PLATELET COUNT DECREASED | WHITE BLOOD CELL DECREASED |
---|
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 | 3 |
,Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 1 | 0 | 1 | 1 | 0 | 1 | 2 | 2 | 1 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 5 | 5 | 0 | 8 | 2 | 7 |
,Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 3 | 0 | 3 | 3 | 2 |
,Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 3 | 1 | 2 | 0 | 1 | 0 | 4 | 4 | 2 | 5 | 4 | 4 | 4 | 3 | 2 | 1 | 2 | 1 | 1 | 1 | 6 | 7 | 1 | 21 | 11 | 16 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Baseline- Positive PD-L1 | Baseline- Negative PD-L1 | Baseline- Unknown PD-L1 | On-treatment (Cycle 2 Day 8)- Positive PD-L1 | On-treatment (Cycle 2 Day 8)- Negative PD-L1 | On-treatment (Cycle 2 Day 8)- Unknown PD-L1 |
---|
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 1 | 4 | 1 | 1 | 0 | 5 |
,Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 6 | 7 | 0 | 2 | 1 | 10 |
,Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 0 | 4 | 2 | 0 | 2 | 4 |
,Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 28 | 13 | 0 | 3 | 6 | 32 |
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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)
Intervention | Participants (Count of Participants) |
---|
| TEAEs | Serious TEAEs |
---|
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 6 | 5 |
,Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 13 | 9 |
,Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 6 | 3 |
,Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 40 | 20 |
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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)
Intervention | Micrograms per milliliter (Geometric Mean) |
---|
| Cycle 1/Day 1- 1 hour | Cycle 1/Day 15- 336 hours | Cycle 2/Day 1- pre-dose | Cycle 2/Day 1- 1 hour | Cycle 2/Day 15- 336 hours | Cycle 3/Day 1- pre-dose | Cycle 3/Day 1- 1 hour | Cycle 3/Day 15- 336 hours | Cycle 6/Day 1- pre-dose | Cycle 6/Day 1- 1 hour | Cycle 10/Day 1- pre-dose | Cycle 10/Day 1- 1 hour | Cycle 14/Day 1- pre-dose | Cycle 14/Day 1- 1 hour |
---|
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 284.1 | 16.51 | 4.328 | 104.5 | 16.82 | 4.878 | 93.81 | 26.17 | 10.86 | 245.4 | 6.620 | 6.040 | 12.24 | 29.05 |
,Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 172.2 | 9.570 | 3.754 | 197.0 | 13.55 | 5.651 | 204.0 | 17.15 | 9.518 | 208.3 | 8.695 | 222.0 | 13.37 | 216.6 |
,Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 173.3 | 12.32 | 4.780 | 164.2 | 16.87 | 8.122 | 147.0 | 19.40 | 11.38 | 92.53 | 9.523 | 179.0 | 14.97 | 215.3 |
,Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 300.2 | 14.71 | 5.013 | 311.9 | 18.66 | 6.771 | 296.8 | 22.55 | 10.39 | 344.0 | 18.55 | 242.9 | 16.49 | 402.2 |
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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)
Intervention | Percentage of Participants (Number) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 50.0 |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 53.8 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 33.3 |
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 39.0 |
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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
Intervention | Mutations per megabase (Mean) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 4.3 |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 2.8 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 4.4 |
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 2.5 |
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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)
Intervention | Months (Median) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | NA |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 9.6 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | NA |
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | NA |
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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)
Intervention | Participants (Count of Participants) |
---|
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin | 5 |
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin | 12 |
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin | 6 |
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin | 37 |
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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
Intervention | Participants (Count of Participants) |
---|
| 4 Months Post Treatment72504367 | 4 Months Post Treatment72504368 | 2 Years Post Treatment72504367 | 2 Years Post Treatment72504368 |
---|
| Lost to Follow-Up | Alive and progression-free post-treatment |
---|
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 4 |
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 0 |
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 0 |
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 3 |
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 3 |
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 1 |
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Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities
To determine the recommended phase II dose (RP2D) and safety profile of AZD1775 in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers. (NCT03345784)
Timeframe: Up to week 5
Intervention | Participants (Count of Participants) |
---|
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | NA |
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | NA |
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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
Intervention | events (Number) |
---|
| All Grade 1-2 Toxicities | Related Grade 1-2 Toxicities | All Grade 3-4 Toxicities | Related Grade 3-4 Toxicities |
---|
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 53 | 36 | 3 | 3 |
,Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 46 | 37 | 8 | 8 |
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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
Intervention | proportion 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.
Intervention | months (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
Intervention | months (Median) |
---|
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN) | 5.5 |
Arm B (Cisplatin/Carboplatin and Etoposide; CE) | 4.9 |
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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
Intervention | dose-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
Intervention | Participants (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
Intervention | number 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)
Intervention | µM (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
Intervention | percentage 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
Intervention | percentage 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
Intervention | µg/g (Mean) |
---|
| Average Tumor Platinum Level | Average Lymph Node Platinum Level |
---|
Neoadjuvant PRV111 (Safety Population) | 337 | 110 |
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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
Intervention | Participants (Count of Participants) |
---|
| Clinical Clearance Day 30 | Clinical Clearance Month 3 |
---|
Basal Cell Carcinoma Patients | 13 | 18 |
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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
Intervention | score on a scale (Median) |
---|
| Day 1 post treatment | Day 3-5 post treatment | Day 30 post treatment | Month 3 post treatment |
---|
Basal Cell Carcinoma Patients | 7 | 9 | 4 | 2 |
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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
Intervention | Participants (Count of Participants) |
---|
Basal Cell Carcinoma Patients | 17 |
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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
Intervention | years (Median) |
---|
Avelumab and Cisplatin IV | NA |
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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
Intervention | proportion of participants (Number) |
---|
Avelumab and Cisplatin IV | 0.5 |
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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)
Intervention | percentage of participants (Number) |
---|
Arm 1: POAmCRT | 40 |
Arm 2: POAmRT | 20 |
Arm 3: POACRT | 75 |
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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)
Intervention | percent 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)
Intervention | Participants (Count of Participants) |
---|
Arm 1: POAmCRT | 2 |
Arm 2: POAmRT | 1 |
Arm 3: POACRT | 3 |
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Change in Serum Creatinine
(NCT03621696)
Timeframe: Baseline to 6 weeks after POAmCRT (approximately 90 days)
Intervention | mg/dL (Mean) |
---|
Arm 1: POAmCRT | 0.03 |
Arm 2: POAmRT | 0.08 |
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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (Count of Participants) |
---|
IMPT for Anal Cancer (Single Arm Trial) | 7 |
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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
Intervention | Participants (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
Intervention | Participants (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.
Intervention | Participants (Count of Participants) |
---|
| Mutation = I1171: deaths | Mutation = None: deaths |
---|
Brigatinib | 0 | 1 |
,Lorlatinib | 0 | 0 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Mutation = None: deaths |
---|
Ensartinib | 2 |
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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.
Intervention | Participants (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
Intervention | Participants (Count of Participants) |
---|
| Mutation = I1171: BOR of CR or PR | Mutation = None: BOR of CR or PR |
---|
Brigatinib | 0 | 1 |
,Lorlatinib | 1 | 2 |
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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
Intervention | Participants (Count of Participants) |
---|
| Mutation = None: BOR of CR or PR |
---|
Ensartinib | 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
Intervention | Participants (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.
Intervention | months (Mean) |
---|
| Mutation = I1171 | Mutation = None |
---|
Lorlatinib | 27.9 | 19.2 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Mutation = none: progression or death |
---|
Ensartinib | 2 |
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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.
Intervention | months (Mean) |
---|
| Mutation = None |
---|
Brigatinib | 3.5 |
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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.
Intervention | Participants (Count of Participants) | Participants (Count of Participants) |
---|
| Mutation = I110772512695 | Mutation = I110772512697 | Mutation = I110772512700 | Mutation = none72512697 | Mutation = none72512695 | Mutation = none72512698 |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
---|
Lorlatinib | 1 |
LDK378 (Ceritinib) | 1 |
LDK378 (Ceritinib) | 0 |
Brigatinib | 0 |
Lorlatinib | 0 |
Lorlatinib | 2 |
Ensartinib | 3 |
Brigatinib | 1 |
Ensartinib | 0 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Mutation = I1107: progression or death | Mutation = none: progression or death |
---|
Brigatinib | 1 | 1 |
,Lorlatinib | 0 | 1 |
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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.
Intervention | Participants (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
Intervention | Percentage of participants (Number) |
---|
Arm A | 68.4 |
Arm B | 52.9 |
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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
Intervention | Percentage of participants (Number) |
---|
Arm A | 71.4 |
Arm B | 50 |
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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
Intervention | Total number of expanded clones (Mean) |
---|
Arm A | 132.7 |
Arm B | 192.8 |
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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).
Intervention | Percentage of participants (Number) |
---|
Arm A | 0 |
Arm B | 21.43 |
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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
Intervention | percentage of PDL-1 expression (Median) |
---|
Arm A | 0.75 |
Arm B | 0.5 |
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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
Intervention | number of unique rearrangements (Median) |
---|
Arm A | 12118 |
Arm B | 12237 |
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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
Intervention | Index (Median) |
---|
Arm A | 0.0505 |
Arm B | 0.0448 |
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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
Intervention | Participants (Count of Participants) |
---|
| Blood and lymphatic system disorders | Cardiac Disorders | Gastrointestinal Disorders | General disorders and administrative site conditions | Infections and Infestations | Investigations | Metabolism and Nutrition Disorders | Musculoskeletal and Connective Tissue Disorders | Renal and Urinary Disorders | Reproductive System and Breast Disorders |
---|
Arm A | 4 | 1 | 2 | 1 | 3 | 2 | 0 | 0 | 1 | 1 |
,Arm B | 6 | 0 | 4 | 0 | 2 | 7 | 4 | 2 | 0 | 2 |
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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
Intervention | months (Median) |
---|
| EORTC QLQ-LC13: Dyspnoea | EORTC QLQ-LC13: Coughing | EORTC QLQ-LC13: Haemoptysis | EORTC QLQ-LC13: Pain In Chest | EORTC QLQ-LC13: Pain In Arm Or Shoulder | EORTC QLQ-LC13: Pain In Other Parts |
---|
Durvalumab/Olaparib Combination Therapy | 10.0 | 11.7 | 15.0 | 13.8 | 15.0 | 10.3 |
,Durvalumab/Placebo Therapy | 9.7 | 10.6 | 12.6 | 11.5 | 9.7 | 10.6 |
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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.
Intervention | change from baseline score (Mean) |
---|
| EORTC QLQ-C30: Fatigue | EORTC QLQ-C30: Appetite loss |
---|
Durvalumab/Olaparib Combination Therapy | 0.15 | -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
Intervention | change from baseline score (Mean) |
---|
| EORTC QLQ-LC13: Dyspnoea | EORTC QLQ-LC13: Coughing | EORTC QLQ-LC13: Pain in chest |
---|
Durvalumab/Olaparib Combination Therapy | -1.27 | -2.14 | 1.31 |
,Durvalumab/Placebo Therapy | -0.76 | -3.09 | 3.57 |
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Concentration of Durvalumab
Concentration (pharmacokinetics) of durvalumab (NCT03775486)
Timeframe: Assessed from start of initial therapy up to 2 years.
Intervention | μg/mL (Geometric Mean) |
---|
| Cycle 01 Day 01 (Initial Therapy Phase) Post dose | Cycle 02 Day 01 (Initial Therapy Phase) Pre dose | Cycle 04 Day 01 (Initial Therapy Phase) Pre dose | Cycle 01 (Maintenance Phase) Post dose | Cycle 02 (Maintenance Phase) Pre dose | Cycle 05 (Maintenance Phase) Pre dose | Cycle 08 (Maintenance Phase) Pre dose | Cycle 11 (Maintenance Phase) Pre dose | Cycle 14 (Maintenance Phase) Pre dose | Cycle 17 (Maintenance Phase) Pre dose | Cycle 20 (Maintenance Phase) Pre dose | Month 03 (Maintenance Phase) Pre dose |
---|
Durvalumab/Olaparib Combination Therapy | 417.152 | 76.812 | 155.461 | 535.078 | 159.157 | 166.644 | 198.932 | 210.794 | 276.612 | 264.096 | 528.046 | 12.289 |
,Durvalumab/Placebo Therapy | 453.724 | 76.959 | 154.947 | 524.306 | 160.315 | 147.848 | 154.057 | 186.092 | 182.042 | 217.137 | 112.276 | 12.769 |
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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.
Intervention | percent (Number) |
---|
| Percentage of participants remaining in response at 3 months | Percentage of participants remaining in response at 6 months | Percentage of participants remaining in response at 9 months | Percentage of participants remaining in response at 12 months |
---|
Durvalumab/Olaparib Combination Therapy | 90.5 | 79.1 | 69.2 | 69.2 |
,Durvalumab/Placebo Therapy | 85.1 | 65.7 | 65.7 | 65.7 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Death | Censored participants (still in survival at follow up or terminated study prior to death) |
---|
Durvalumab/Olaparib Combination Therapy | 44 | 90 |
,Durvalumab/Placebo Therapy | 45 | 90 |
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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.
Intervention | Participants (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 baseline | ADA positive post-baseline and not detected at baseline (treatment-induced) | ADA not detected at post-baseline and positive at baseline | Treatment-boosted ADA | Persistent positive | Transient positive | Neutralizing anti-drug antibody positive at any visit |
---|
Durvalumab/Olaparib Combination Therapy | 11 | 5 | 0 | 5 | 6 | 0 | 0 | 5 | 1 |
,Durvalumab/Placebo Therapy | 9 | 4 | 1 | 4 | 4 | 0 | 3 | 2 | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
| RECIST progression: Target Lesions | RECIST progression: Non Target Lesions | RECIST progression: New Lesions | Death in the absence of progression | Censored subjects: Censored RECIST progression | Censored subjects: Censored death | Censored subjects: Progression-free at time of analysis | Censored subjects: Progression-free prior to lost to follow-up | Censored subjects: Progression-free prior to withdrawal of consent | Censored subjects: Progression-free prior to discontinuation due to other reason | Censored subjects: No post-baseline evaluable tumor assessment |
---|
Durvalumab/Olaparib Combination Therapy | 40 | 28 | 44 | 8 | 0 | 1 | 44 | 0 | 3 | 0 | 2 |
,Durvalumab/Placebo Therapy | 63 | 30 | 39 | 9 | 0 | 0 | 34 | 0 | 2 | 0 | 2 |
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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.
Intervention | time to deterioration (months) (Median) |
---|
| EORTC QLQ-C30: Fatigue | EORTC QLQ-C30: Nausea And Vomiting | EORTC QLQ-C30: Pain | EORTC QLQ-C30: Dyspnoea | EORTC QLQ-C30: Insomnia | EORTC QLQ-C30: Appetite Loss | EORTC QLQ-C30: Constipation | EORTC QLQ-C30: Diarrhoea | Physical Functioning | Role Functioning | Emotional Functioning | Cognitive Functioning | Social Functioning | Global Health Status/Quality of Life |
---|
Durvalumab/Olaparib Combination Therapy | 8.8 | 12.2 | 10.2 | 12.2 | 13.8 | 11.7 | 12.2 | 13.8 | 12.0 | 10.0 | 12.2 | 10.2 | 9.3 | 10.2 |
,Durvalumab/Placebo Therapy | 10 | 12.6 | 9.7 | 11.0 | 10.6 | 11.5 | 12.0 | 11.5 | 12.0 | 10.6 | 11.0 | 10.6 | 10.0 | 9.7 |
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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
Intervention | Percentage 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
Intervention | Percent 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
Intervention | Percentage 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
Intervention | percentage 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
Intervention | Percent 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
Intervention | Participants (Count of Participants) |
---|
| Safety Population71994742 | Per Protocol Population71994742 | By Treatment Cycle Population71994742 |
---|
| Responders, Central Reviewer | Non-Responders, Central Reviewer |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 41 |
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 12 |
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 30 |
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 21 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 8 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 7 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 6 |
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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
Intervention | micrograms/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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 7 |
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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
Intervention | micrograms/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
Intervention | micrograms/Liter (Mean) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 4.154 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 40 |
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Disease Control Rate (DCR), Local Reviewer
Disease control rate (DCR), Local Reviewer, 6 Months (NCT03790111)
Timeframe: Month 6
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 40 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 40 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 7 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 35 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 33 |
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Change From Baseline in Serum Albumin
Mean change from Baseline to Month 6 serum albumin levels (NCT03790111)
Timeframe: Month 6
Intervention | g/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
Intervention | g/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
Intervention | g/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
Intervention | Units 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
Intervention | U/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
Intervention | U/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
Intervention | Months (Median) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 7.467 |
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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
Intervention | Proportion of participants (Number) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 0.60 |
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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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 33 |
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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
Intervention | Proportion of participants (Number) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 0.87 |
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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
Intervention | Months (Median) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 7.000 |
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Weight Change From Baseline
Mean change in weight at Month 12 from baseline measurement (NCT03790111)
Timeframe: Month 12
Intervention | kg (Mean) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 1.69 |
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Weight Change From Baseline
Mean change in weight at Month 6 from baseline measurement (NCT03790111)
Timeframe: Month 6
Intervention | kg (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
Intervention | Participants (Count of Participants) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 8 |
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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
Intervention | Months (Median) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 17.667 |
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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
Intervention | Months (Median) |
---|
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 7.467 |
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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
Intervention | kg (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
Intervention | Months (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Percentage 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
Intervention | Months (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
Intervention | Months (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
Intervention | mg (Number) |
---|
Anlotinib Hydrochloride Combined With AP | 10 |
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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)
Intervention | participants (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)
Intervention | participants (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
Intervention | months (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)
Intervention | participants (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
Intervention | Months (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
Intervention | Months (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
Intervention | Percentage (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Months (Median) |
---|
Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 10.2 |
Arm B (Placebo+Gemcitabine+Cisplatin) | 5.7 |
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