Page last updated: 2024-11-10

cactinomycin

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Description

cactinomycin: a mixture of dactinomycin, actinomycin C2, and actinomycin C3 [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID3084037
SCHEMBL ID1650567
MeSH IDM0095292

Synonyms (22)

Synonym
0occ969v50 ,
cactinomycine
unii-0occ969v50
cactinomycinum
cactinomicina
nsc 18268
actinomycin d, 2(sup a)-d-alloisoleucine-2(sup b)-d-alloisoleucine-, mixt. with actinomycin d and 2(sup a)-d-alloisoleucineactinomycin d
cactinomycin [usan:inn]
sanamicia
cactinomycine [inn-french]
cactinomicina [inn-spanish]
einecs 232-485-1
h.b.f. 386
cactinomycinum [inn-latin]
8052-16-2
sanamycin
actinochrysin
nsc-18268
actinomycin c
cactinomycin
2-amino-1-n-[(3s,6s,7r,10s,16s)-3-[(2s)-butan-2-yl]-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-10-propan-2-yl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-4,6-dimethyl-3-oxo-9-n-[(3s,6s,7r,10s,16s)-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propa
SCHEMBL1650567

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"Prostaglandins (PGs) have been shown to cytoprotect various tissue types against the toxic effects of many chemicals."( The cytoprotective properties of prostaglandin E2 against the toxic effects of actinomycin C on embryonic neural retina cells.
Dymond, JB; Kalmus, GW, 1992
)
0.28
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (89)

TimeframeStudies, This Drug (%)All Drugs %
pre-199066 (74.16)18.7374
1990's10 (11.24)18.2507
2000's9 (10.11)29.6817
2010's4 (4.49)24.3611
2020's0 (0.00)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1 (0.99%)5.53%
Reviews1 (0.99%)6.00%
Case Studies2 (1.98%)4.05%
Observational0 (0.00%)0.25%
Other97 (96.04%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (10)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma [NCT00075582]Phase 3390 participants (Actual)Interventional2004-09-04Completed
"A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus Pulsed Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia" [NCT00003702]Phase 3240 participants (Actual)Interventional1999-06-30Completed
Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor [NCT00352534]Phase 3808 participants (Actual)Interventional2006-10-30Active, not recruiting
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors [NCT00379340]Phase 3395 participants (Actual)Interventional2007-02-26Active, not recruiting
Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS) [NCT00354835]Phase 3481 participants (Actual)Interventional2006-12-26Completed
A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma [NCT05304585]Phase 3205 participants (Anticipated)Interventional2022-08-04Recruiting
A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance i [NCT04994132]Phase 3118 participants (Anticipated)Interventional2021-09-14Recruiting
A Phase I/II Study of Isolated Limb Infusion and Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma [NCT01531244]Phase 1/Phase 20 participants (Actual)Interventional2014-12-31Withdrawn
Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor [NCT00945009]Phase 3249 participants (Actual)Interventional2009-07-13Active, not recruiting
Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma [NCT00003958]Phase 3702 participants (Actual)Interventional2002-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00003702 (3) [back to overview]Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
NCT00003702 (3) [back to overview]Number of Patients With a Decline of hCG on Day 1 of Treatment
NCT00003702 (3) [back to overview]Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
NCT00075582 (6) [back to overview]Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose
NCT00075582 (6) [back to overview]Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
NCT00075582 (6) [back to overview]Percentage of Patients With Delayed Surgical Procedures
NCT00075582 (6) [back to overview]Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry
NCT00075582 (6) [back to overview]Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
NCT00075582 (6) [back to overview]Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry
NCT00352534 (4) [back to overview]Event Free Survival Probability
NCT00352534 (4) [back to overview]Incidence of Contralateral Kidney Lesions
NCT00352534 (4) [back to overview]Incidence of Renal Failure
NCT00352534 (4) [back to overview]Overall Survival (OS) Probability
NCT00354835 (13) [back to overview]Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
NCT00354835 (13) [back to overview]Response Rate (RR)
NCT00354835 (13) [back to overview]Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC
NCT00354835 (13) [back to overview]Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype
NCT00354835 (13) [back to overview]Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15
NCT00354835 (13) [back to overview]Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4
NCT00354835 (13) [back to overview]Event Free Survival (EFS)
NCT00354835 (13) [back to overview]Event Free Survival (EFS) by PAX Status
NCT00354835 (13) [back to overview]Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
NCT00354835 (13) [back to overview]Incidence of Bladder Dysfunction
NCT00354835 (13) [back to overview]Incidence of Toxicity
NCT00354835 (13) [back to overview]Local Failure
NCT00354835 (13) [back to overview]Overall Survival (OS)
NCT00379340 (4) [back to overview]Event Free Survival (EFS) Probability
NCT00379340 (4) [back to overview]Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
NCT00379340 (4) [back to overview]Event Free Survival Probability
NCT00379340 (4) [back to overview]Event Free Survival Probability
NCT00945009 (5) [back to overview]Event-Free Survival (EFS)
NCT00945009 (5) [back to overview]Kidney Preservation After Preoperative Chemotherapy
NCT00945009 (5) [back to overview]Number of Patients Without Complete Removal of at Least One Kidney
NCT00945009 (5) [back to overview]Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy
NCT00945009 (5) [back to overview]Percentage of Patients Who Had Definitive Surgical Treatment

Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0

Number of participants with a maximum grade of 3 or higher during the treatment period. (NCT00003702)
Timeframe: Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.

InterventionParticipants (Count of Participants)
Arm 1: Methotrexate 30 mg/m2 IM Weekly14
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks20

[back to top]

Number of Patients With a Decline of hCG on Day 1 of Treatment

Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start. (NCT00003702)
Timeframe: Prior to study entry and on Day 1 of treatment

InterventionParticipants (Count of Participants)
Enrolled Participants72

[back to top]

Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay

Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements. (NCT00003702)
Timeframe: Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.

,
InterventionParticipants (Count of Participants)
Complete/CureNon-responseInevaluable
Arm 1: Methotrexate 30 mg/m2 IM Weekly57482
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks76294

[back to top]

Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose

The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection. (NCT00075582)
Timeframe: From enrollment up to 20 weeks

InterventionEstimated percentage of participants (Number)
Regimen II (Stage I Group III Nonorbit or Stage III Group I/II0

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Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy

The local failure rate will be estimated using cumulative incidence curves. (NCT00075582)
Timeframe: From enrollment up to 5 years

Interventionstimated percentage of participants (Number)
Regimen I (Chemotherapy, Radiotherapy)0.081
Regimen II (Chemotherapy, Radiotherapy, Surgery)0.115

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Percentage of Patients With Delayed Surgical Procedures

The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated. (NCT00075582)
Timeframe: At 13 weeks after induction

Interventionpercentage of participants (Number)
Regimen II (Stage I Group III Nonorbit or Stage III Group I/II0.49

[back to top]

Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry

Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first. (NCT00075582)
Timeframe: From enrollment up to 5 years

InterventionEstimated percentage of participants (Number)
Regimen I (Chemotherapy, Radiotherapy)87
Regimen II (Chemotherapy, Radiotherapy, Surgery)67

[back to top]

Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry

Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first. (NCT00075582)
Timeframe: From enrollment up to 5 years

InterventionEstimated percentage of participants (Number)
Regimen II (Chemotherapy, Radiotherapy, Surgery)67

[back to top]

Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry

Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first. (NCT00075582)
Timeframe: From enrollment up to 5 years

InterventionEstimated percentage of participants (Number)
Regimen I (Chemotherapy, Radiotherapy)90

[back to top]

Event Free Survival Probability

Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00352534)
Timeframe: 4 years

InterventionProbability (Number)
Very Low Risk0.88
Standard Risk, Stage I or II, With LOH0.87
Standard Risk, Stage III0.88

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Incidence of Contralateral Kidney Lesions

Number of contralateral kidney lesions during follow-up. (NCT00352534)
Timeframe: During follow-up

InterventionLesions (Number)
Very Low Risk1

[back to top]

Incidence of Renal Failure

Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up (NCT00352534)
Timeframe: During follow-up

InterventionIncidents (Number)
Very Low Risk0

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Overall Survival (OS) Probability

Probability of being alive after 4 years in the study. (NCT00352534)
Timeframe: 4 years

InterventionProbability (Number)
Very Low Risk1.00
Standard Risk, Stage I or II, With LOH1.00
Standard Risk, Stage III0.97

[back to top]

Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison

Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70. (NCT00354835)
Timeframe: 4 years

InterventionProbability (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.7293

[back to top]

Response Rate (RR)

Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR. (NCT00354835)
Timeframe: Reporting Period 1 (Weeks 1 - 15)

InterventionProportion (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.6667
VAC Alternating With Vincristine, Irinotecan (VI)0.6726

[back to top]

Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC

The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons. (NCT00354835)
Timeframe: Up to 43 weeks

,
Interventionparticipants (Number)
AnemiaFebrile NeutropeniaNausea or HepatopathyPlatelet Count DecreasedVomiting
VAC (Weeks 1-15)58306279
VAC (Weeks 31 - 43)54171632

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Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15

4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study) (NCT00354835)
Timeframe: 4 years

InterventionProbability (Number)
% Change in SUVmax From Baseline to Week 15 < 40%0.6667
% Change in SUVmax From Baseline to Week 15 >= 40%0.5686

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Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4

4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study). (NCT00354835)
Timeframe: 4 years

InterventionProbability (Number)
% Change in SUVmax From Baseline to Week 4 < 40%0.2857
% Change in SUVmax From Baseline to Week 4 >= 40%0.6364

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Event Free Survival (EFS)

Probability of no relapse, secondary malignancy, or death after 4 year in the study (NCT00354835)
Timeframe: 4 years

InterventionProbability (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.6255
VAC Alternating With Vincristine, Irinotecan (VI)0.5874

[back to top]

Event Free Survival (EFS) by PAX Status

(NCT00354835)
Timeframe: 4 years

InterventionProbability (Number)
PAX30.51
PAX70.66

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Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison

Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65. (NCT00354835)
Timeframe: 4 years

InterventionProbability (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.6255

[back to top]

Incidence of Bladder Dysfunction

Number of patients with a summary score greater than 8.5 (NCT00354835)
Timeframe: 3-6 years after enrollment

InterventionParticipant (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)2
VAC Alternating With Vincristine, Irinotecan (VI)1

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Incidence of Toxicity

Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3. (NCT00354835)
Timeframe: Up to 15 weeks

InterventionProbability (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.2072
VAC Alternating With Vincristine, Irinotecan (VI)0.3673

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Local Failure

Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13. (NCT00354835)
Timeframe: 2 years

InterventionProportion of participants (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.1757

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Overall Survival (OS)

Probability of being alive after 4 years in the study. (NCT00354835)
Timeframe: 4 years

InterventionProbability (Number)
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.7293
VAC Alternating With Vincristine, Irinotecan (VI)0.7223

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Event Free Survival (EFS) Probability

Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: At 4 years

InterventionProbability of EFS at 4 years (Number)
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases0.89

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Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease

Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: At 4 years

InterventionProbability (Number)
Lung Mets <= 1cm0.88
Lung Mets > 1cm0.82

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Event Free Survival Probability

Probability of no relapse, secondary malignancy, or death after 4 year in the study (NCT00379340)
Timeframe: At 4 years

InterventionProbability of EFS at 4 years (Number)
Stage III/IV With LOH 1p and 16q Treated With Regimen M0.90
Stage IV With Non-lung Disease Treated With Regimen M0.73

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Event Free Survival Probability

Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: 4 years

InterventionProbability (Number)
Stage IV and Rapid Complete Response (RCR) of Lung Metastases0.79

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Event-Free Survival (EFS)

Probability of no relapse, secondary malignancy, or death whichever occurs first (NCT00945009)
Timeframe: 4 years from study enrollment

InterventionProbability (Mean)
Arm 1 (Bilateral Wilms Tumors)0.82

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Kidney Preservation After Preoperative Chemotherapy

Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT). (NCT00945009)
Timeframe: 12 weeks from study entry

InterventionPercentage of patients (Number)
Arm 1 (Bilateral Wilms Tumors)39

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Number of Patients Without Complete Removal of at Least One Kidney

To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development. (NCT00945009)
Timeframe: 12 weeks from the study entry

InterventionParticipants (Count of Participants)
Arm 3 (DHPLN)7

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Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy

Percentage of patients who experienced partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin. (NCT00945009)
Timeframe: 12 weeks from study entry

Interventionpercentage of patients (Number)
Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)57

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Percentage of Patients Who Had Definitive Surgical Treatment

Percentage of Bilateral Wilms Tumor (BWT) patients who undergo definitive surgery by week 12 after initiation of chemotherapy. (NCT00945009)
Timeframe: 12 weeks from study entry

Interventionpercentage of participants (Number)
Arm 1 (Bilateral Wilms Tumors)85

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