Trial · NCT00379340

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

NCT00379340, Phase 3, Completed, Children's Oncology Group; results first posted 2017-06-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor. Trials, record NCT00379340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00379340

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
NCT number: NCT00379340
Status: Completed
Phases: Phase 3
Enrollment: 395 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor
Interventions: 3-Dimensional Conformal Radiation Therapy, Conventional Surgery, Cyclophosphamide, Dactinomycin, Doxorubicin Hydrochloride, Etoposide, Vincristine Sulfate Liposome
First posted: 2006-09-21
Last updated: 2026-07-24
Results first posted: 2017-06-14

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event Free Survival Probability	4 years	Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Primary	Event Free Survival (EFS) Probability	At 4 years	Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Primary	Event Free Survival Probability	At 4 years	Probability of no relapse, secondary malignancy, or death after 4 year in the study
Secondary	Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease	At 4 years	Probability of no relapse, secondary malignancy, or death after 4 year in the study.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event Free Survival Probability	4 years		Probability	NUMBER
PRIMARY	Event Free Survival (EFS) Probability	At 4 years	Analysis includes only eligible patients.	Probability of EFS at 4 years	NUMBER
PRIMARY	Event Free Survival Probability	At 4 years	All eligible patients were included in this analysis.	Probability of EFS at 4 years	NUMBER
SECONDARY	Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease	At 4 years	Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.	Probability	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Event Free Survival Probability	Stage IV and Rapid Complete Response (RCR) of Lung Metastases	0.79	95% Confidence Interval 0.70 to 0.87	Probability
Event Free Survival (EFS) Probability	Stage IV and Slow Incomplete Response (SIR) of Lung Metastases	0.89	95% Confidence Interval 0.82 to 0.95	Probability of EFS at 4 years
Event Free Survival Probability	Stage III/IV With LOH 1p and 16q Treated With Regimen M	0.90	95% Confidence Interval 0.80 to 1	Probability of EFS at 4 years
Event Free Survival Probability	Stage IV With Non-lung Disease Treated With Regimen M	0.73	95% Confidence Interval 0.59 to 0.88	Probability of EFS at 4 years
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease	Lung Mets <= 1cm	0.88	95% Confidence Interval 0.82 to 0.95	Probability
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease	Lung Mets > 1cm	0.82	95% Confidence Interval 0.75 to 0.90	Probability

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stage IV and Rapid Complete Response (RCR) of Lung Metastases	120
Overall Study	STARTED	Stage IV and Slow Incomplete Response (SIR) of Lung Metastases	135
Overall Study	STARTED	Stage III/IV With LOH 1p and 16q Treated With Regimen M	52
Overall Study	STARTED	Stage IV With Non-lung Disease Treated With Regimen M	50
Overall Study	STARTED	Stage IV With Lung Metastases	23
Overall Study	COMPLETED	Stage IV and Rapid Complete Response (RCR) of Lung Metastases	107
Overall Study	COMPLETED	Stage IV and Slow Incomplete Response (SIR) of Lung Metastases	132
Overall Study	COMPLETED	Stage III/IV With LOH 1p and 16q Treated With Regimen M	50
Overall Study	COMPLETED	Stage IV With Non-lung Disease Treated With Regimen M	37
Overall Study	COMPLETED	Stage IV With Lung Metastases	9

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events665

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal infection	Infections and infestations	Stage IV and Rapid Complete Response (RCR) of Lung Metastases	0	120	0
other	Abdominal infection	Infections and infestations	Stage IV and Slow Incomplete Response (SIR) of Lung Metastases	0	135	0
other	Abdominal infection	Infections and infestations	Stage III/IV With LOH 1p and 16q Treated With Regimen M	1	52	1
other	Abdominal infection	Infections and infestations	Stage IV With Non-lung Disease Treated With Regimen M	1	50	1
other	Abdominal infection	Infections and infestations	Stage IV With Lung Metastases	0	23	0
other	Abdominal pain	Gastrointestinal disorders	Stage IV and Rapid Complete Response (RCR) of Lung Metastases	0	120	0
other	Abdominal pain	Gastrointestinal disorders	Stage IV and Slow Incomplete Response (SIR) of Lung Metastases	1	135	1
other	Abdominal pain	Gastrointestinal disorders	Stage III/IV With LOH 1p and 16q Treated With Regimen M	1	52	1
other	Abdominal pain	Gastrointestinal disorders	Stage IV With Non-lung Disease Treated With Regimen M	2	50	2
other	Abdominal pain	Gastrointestinal disorders	Stage IV With Lung Metastases	0	23	0

1 to 10 of 665Source ClinicalTrials.gov

See all 665 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stage IV and Rapid Complete Response (RCR) of Lung Metastases
Total, all-cause mortality	Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
Total, all-cause mortality	Stage III/IV With LOH 1p and 16q Treated With Regimen M
Total, all-cause mortality	Stage IV With Non-lung Disease Treated With Regimen M
Total, all-cause mortality	Stage IV With Lung Metastases
Total, other adverse events	Stage IV and Rapid Complete Response (RCR) of Lung Metastases	11	120
Total, other adverse events	Stage IV and Slow Incomplete Response (SIR) of Lung Metastases	90	135
Total, other adverse events	Stage III/IV With LOH 1p and 16q Treated With Regimen M	35	52
Total, other adverse events	Stage IV With Non-lung Disease Treated With Regimen M	37	50
Total, other adverse events	Stage IV With Lung Metastases	1	23

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29659330	DERIVED	PubMed
31449468	DERIVED	PubMed
35580298	DERIVED	PubMed
37933882	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00379340

GET https://conductscience.org/api/trials/v1/NCT00379340/events?page=2

API reference For AI assistants