Trial · NCT00352534

Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

NCT00352534, Phase 3, Completed, Children's Oncology Group; results first posted 2017-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor. Trials, record NCT00352534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00352534

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Trial

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

Title: Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor
NCT number: NCT00352534
Status: Completed
Phases: Phase 3
Enrollment: 808 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor
Interventions: 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, Chest Radiography, Computed Tomography, Dactinomycin, Doxorubicin Hydrochloride, Echocardiography Test, Magnetic Resonance Imaging, Therapeutic Conventional Surgery, Ultrasound Imaging, Vincristine Sulfate
First posted: 2006-07-14
Last updated: 2026-06-03
Results first posted: 2017-05-15

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	Overall Survival (OS) Probability	4 years	Probability of being alive after 4 years in the study.
Secondary	Incidence of Contralateral Kidney Lesions	During follow-up	Number of contralateral kidney lesions during follow-up.
Secondary	Incidence of Renal Failure	During follow-up	Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up

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	Eligible very low risk or standard risk patients	Probability	NUMBER
PRIMARY	Overall Survival (OS) Probability	4 years	Eligible very low risk or standard risk patients	Probability	NUMBER
SECONDARY	Incidence of Contralateral Kidney Lesions	During follow-up	Very low risk patients treated by nephrectomy and observation only.	Lesions	NUMBER
SECONDARY	Incidence of Renal Failure	During follow-up	Very low risk patients that have metachronous relapse.	Incidents	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Event Free Survival Probability	Very Low Risk	0.88	95% Confidence Interval 0.79 to 0.98	Probability
Event Free Survival Probability	Standard Risk, Stage I or II, With LOH	0.87	95% Confidence Interval 0.73 to 1.00	Probability
Event Free Survival Probability	Standard Risk, Stage III	0.88	95% Confidence Interval 0.85 to 0.91	Probability
Overall Survival (OS) Probability	Very Low Risk	1.00	95% Confidence Interval 1 to 1	Probability
Overall Survival (OS) Probability	Standard Risk, Stage I or II, With LOH	1.00	95% Confidence Interval 1 to 1	Probability
Overall Survival (OS) Probability	Standard Risk, Stage III	0.97	95% Confidence Interval 0.95 to 0.99	Probability
Incidence of Contralateral Kidney Lesions	Very Low Risk	1		Lesions
Incidence of Renal Failure	Very Low Risk	0		Incidents

Source ClinicalTrials.gov

Participant flow42

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

Period	Milestone	Group	Participants
Initial Staging	STARTED	Stage I/II	211
Initial Staging	STARTED	Stage III	597
Initial Staging	STARTED	Very Low Risk Disease	0
Initial Staging	STARTED	Low Risk, Stage I or II, no LOH	0
Initial Staging	STARTED	Standard Risk, Stage I or II With LOH	0
Initial Staging	STARTED	Standard Risk, Stage III	0
Initial Staging	STARTED	High Risk	0
Initial Staging	COMPLETED	Stage I/II	203
Initial Staging	COMPLETED	Stage III	588
Initial Staging	COMPLETED	Very Low Risk Disease	0

1 to 10 of 42Source ClinicalTrials.gov

See all 42 participant flow

Adverse events175

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	11600-Alanine aminotransferase increased	Investigations	Very Low Risk Disease	0	116	0
other	11600-Alanine aminotransferase increased	Investigations	Low Risk, Stage I or II, no LOH	0	51	0
other	11600-Alanine aminotransferase increased	Investigations	Standard Risk, Stage I or II, With LOH	0	32	0
other	11600-Alanine aminotransferase increased	Investigations	Standard Risk, Stage III	5	535	6
other	11600-Alanine aminotransferase increased	Investigations	High Risk	0	40	0
other	14900-Ascites	Gastrointestinal disorders	Very Low Risk Disease	0	116	0
other	14900-Ascites	Gastrointestinal disorders	Low Risk, Stage I or II, no LOH	0	51	0
other	14900-Ascites	Gastrointestinal disorders	Standard Risk, Stage I or II, With LOH	0	32	0
other	14900-Ascites	Gastrointestinal disorders	Standard Risk, Stage III	2	535	2
other	14900-Ascites	Gastrointestinal disorders	High Risk	0	40	0

1 to 10 of 175Source ClinicalTrials.gov

See all 175 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Very Low Risk Disease
Total, all-cause mortality	Low Risk, Stage I or II, no LOH
Total, all-cause mortality	Standard Risk, Stage I or II, With LOH
Total, all-cause mortality	Standard Risk, Stage III
Total, all-cause mortality	High Risk
Total, other adverse events	Very Low Risk Disease	0	116
Total, other adverse events	Low Risk, Stage I or II, no LOH	2	51
Total, other adverse events	Standard Risk, Stage I or II, With LOH	0	32
Total, other adverse events	Standard Risk, Stage III	31	535
Total, other adverse events	High Risk	0	40

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27811504	DERIVED	PubMed
29211618	DERIVED	PubMed
31449468	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.

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