Trial · NCT00945009

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

NCT00945009, Phase 3, Completed, Children's Oncology Group; results first posted 2019-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor. Trials, record NCT00945009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00945009

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Trial

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

Title: Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
NCT number: NCT00945009
Status: Completed
Phases: Phase 3
Enrollment: 249 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Adult Kidney Wilms Tumor, Beckwith-Wiedemann Syndrome, Childhood Kidney Wilms Tumor, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Rhabdoid Tumor of the Kidney, Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor, Stage V Kidney Wilms Tumor
Interventions: Dactinomycin, Doxorubicin Hydrochloride, Radiation Therapy, Therapeutic Conventional Surgery, Vincristine Sulfate
First posted: 2009-07-23
Last updated: 2026-06-03
Results first posted: 2019-03-05

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Event-Free Survival (EFS)	4 years from study enrollment	Probability of no relapse, secondary malignancy, or death whichever occurs first
Primary	Kidney Preservation After Preoperative Chemotherapy	12 weeks from study entry	Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT).
Primary	Number of Patients Without Complete Removal of at Least One Kidney	12 weeks from the study entry	To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.
Primary	Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy	12 weeks from study entry	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.
Primary	Percentage of Patients Who Had Definitive Surgical Treatment	12 weeks from study entry	Percentage of Bilateral Wilms Tumor (BWT) patients who undergo definitive surgery by week 12 after initiation of chemotherapy.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-Free Survival (EFS)	4 years from study enrollment	All eligible BWT patients. 6 patients were excluded due to ineligibility and 6 patients were excluded due to protocol violation.	Probability	MEAN
PRIMARY	Kidney Preservation After Preoperative Chemotherapy	12 weeks from study entry	Eligible and evaluable Bilateral Wilms Tumor patients who completed pre-nephrectomy chemotherapy (VAD). 49 patients who did not complete VAD were excluded.	Percentage of patients	NUMBER
PRIMARY	Number of Patients Without Complete Removal of at Least One Kidney	12 weeks from the study entry	Eligible and evaluable patients with diffuse hyperplastic perilobar nephroblastomatosis (DPHLN).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy	12 weeks from study entry	Eligible and evaluable patients with unilateral high risk tumors who had partial or complete nephrectomy. 16 total patients were excluded (1 ineligible, 1 inevaluable, 1 violated protocol, and 13 did not have definitive surgery (partial or complete nephrectomy).	percentage of patients	NUMBER
PRIMARY	Percentage of Patients Who Had Definitive Surgical Treatment	12 weeks from study entry	Eligible and evaluable Bilateral Wilms Tumor patients. 6 patients were excluded due to ineligible and 6 patients were excluded due to protocol violation.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
Event-Free Survival (EFS)	Arm 1 (Bilateral Wilms Tumors)	0.82	95% Confidence Interval 0.74 to 0.91	Probability
Kidney Preservation After Preoperative Chemotherapy	Arm 1 (Bilateral Wilms Tumors)	39	95% Confidence Interval 31 to 47	Percentage of patients
Number of Patients Without Complete Removal of at Least One Kidney	Arm 3 (DHPLN)	7		Participants
Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	57	95% Confidence Interval 37 to 77	percentage of patients
Percentage of Patients Who Had Definitive Surgical Treatment	Arm 1 (Bilateral Wilms Tumors)	85	95% Confidence Interval 80 to 90	percentage of participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1 (Bilateral Wilms Tumors)	201
Overall Study	STARTED	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	39
Overall Study	STARTED	Arm 3 (DHPLN)	9
Overall Study	COMPLETED	Arm 1 (Bilateral Wilms Tumors)	156
Overall Study	COMPLETED	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	32
Overall Study	COMPLETED	Arm 3 (DHPLN)	6
Overall Study	NOT COMPLETED	Arm 1 (Bilateral Wilms Tumors)	45
Overall Study	NOT COMPLETED	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	7
Overall Study	NOT COMPLETED	Arm 3 (DHPLN)	3

Source ClinicalTrials.gov

Adverse events162

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	10300-Abdominal pain	Gastrointestinal disorders	Arm 1 (Bilateral Wilms Tumors)	1	189	1
other	10300-Abdominal pain	Gastrointestinal disorders	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	0	36	0
other	10300-Abdominal pain	Gastrointestinal disorders	Arm 3 (DHPLN)	0	9	0
other	10700-Acidosis	Metabolism and nutrition disorders	Arm 1 (Bilateral Wilms Tumors)	1	189	1
other	10700-Acidosis	Metabolism and nutrition disorders	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	0	36	0
other	10700-Acidosis	Metabolism and nutrition disorders	Arm 3 (DHPLN)	0	9	0
other	11100-Acute kidney injury	Renal and urinary disorders	Arm 1 (Bilateral Wilms Tumors)	3	189	3
other	11100-Acute kidney injury	Renal and urinary disorders	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	0	36	0
other	11100-Acute kidney injury	Renal and urinary disorders	Arm 3 (DHPLN)	0	9	0
other	11600-Alanine aminotransferase increased	Investigations	Arm 1 (Bilateral Wilms Tumors)	1	189	1

1 to 10 of 162Source ClinicalTrials.gov

See all 162 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1 (Bilateral Wilms Tumors)	10	189
Total, all-cause mortality	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	0	36
Total, all-cause mortality	Arm 3 (DHPLN)	0	9
Total, other adverse events	Arm 1 (Bilateral Wilms Tumors)	34	189
Total, other adverse events	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	1	36
Total, other adverse events	Arm 3 (DHPLN)	0	9
Total, serious adverse events	Arm 1 (Bilateral Wilms Tumors)	12	189
Total, serious adverse events	Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)	1	36
Total, serious adverse events	Arm 3 (DHPLN)	0	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35072864	DERIVED

Source 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/NCT00945009

GET https://conductscience.org/api/trials/v1/NCT00945009/events?page=2

API reference For AI assistants