Trial Outcomes & Findings for 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 NCT00352534)

NCT ID: NCT00352534

Last Updated: 2025-05-07

Results Overview

Probability of no relapse, secondary malignancy, or death after 4 year in the study.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 808 participants
• Primary outcome timeframe: 4 years
• Results posted on: 2025-05-07

Participant Flow

Participant milestones

Measure	Stage I/II Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment	Stage III Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.	Very Low Risk Disease Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.	Low Risk, Stage I or II, no LOH Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).	Standard Risk, Stage I or II With LOH Treatment arm. Standard Risk, Stage I or II with LOH.	Standard Risk, Stage III Treatment arm. Standard Risk, Stage III.	High Risk Treatment arm. High risk.
Initial Staging STARTED	211	597	0	0	0	0	0
Initial Staging COMPLETED	203	588	0	0	0	0	0
Initial Staging NOT COMPLETED	8	9	0	0	0	0	0
Final Risk Group Assignment STARTED	0	0	119	52	32	548	40
Final Risk Group Assignment COMPLETED	0	0	116	49	31	503	1
Final Risk Group Assignment NOT COMPLETED	0	0	3	3	1	45	39

Reasons for withdrawal

Measure	Stage I/II Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment	Stage III Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.	Very Low Risk Disease Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.	Low Risk, Stage I or II, no LOH Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).	Standard Risk, Stage I or II With LOH Treatment arm. Standard Risk, Stage I or II with LOH.	Standard Risk, Stage III Treatment arm. Standard Risk, Stage III.	High Risk Treatment arm. High risk.
Initial Staging Ineligible	8	9	0	0	0	0	0
Final Risk Group Assignment Lack of Efficacy	0	0	0	2	1	19	0
Final Risk Group Assignment Physician Decision	0	0	0	0	0	8	0
Final Risk Group Assignment Withdrawal by Subject	0	0	0	0	0	3	0
Final Risk Group Assignment Ineligible	0	0	3	1	0	13	0
Final Risk Group Assignment Enrollment onto another COG study	0	0	0	0	0	0	28
Final Risk Group Assignment Stage III Wilms tumor with LOH	0	0	0	0	0	0	11
Final Risk Group Assignment Death	0	0	0	0	0	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Stage I or II n=211 Participants Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment.	Stage III n=597 Participants Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.	Total n=808 Participants Total of all reporting groups
Age, Continuous	23.91 Months STANDARD_DEVIATION 24.37 • n=93 Participants	50.62 Months STANDARD_DEVIATION 30.89 • n=4 Participants	43.64 Months STANDARD_DEVIATION 31.83 • n=27 Participants
Sex: Female, Male Female	110 Participants n=93 Participants	318 Participants n=4 Participants	428 Participants n=27 Participants
Sex: Female, Male Male	101 Participants n=93 Participants	279 Participants n=4 Participants	380 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=93 Participants	89 Participants n=4 Participants	127 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	165 Participants n=93 Participants	482 Participants n=4 Participants	647 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants	26 Participants n=4 Participants	34 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	15 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	39 Participants n=93 Participants	89 Participants n=4 Participants	128 Participants n=27 Participants
Race (NIH/OMB) White	141 Participants n=93 Participants	417 Participants n=4 Participants	558 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=93 Participants	70 Participants n=4 Participants	98 Participants n=27 Participants

PRIMARY outcome

Timeframe: 4 years

Population: Eligible very low risk or standard risk patients

Probability of no relapse, secondary malignancy, or death after 4 year in the study.

Outcome measures

Measure	Very Low Risk n=116 Participants Very Low Risk	Standard Risk, Stage I or II, With LOH n=32 Participants Standard Risk, Stage I or II, with LOH	Standard Risk, Stage III n=535 Participants Standard Risk, Stage III
Event Free Survival Probability	0.88 Probability Interval 0.79 to 0.98	0.87 Probability Interval 0.73 to 1.0	0.88 Probability Interval 0.85 to 0.91

PRIMARY outcome

Timeframe: 4 years

Population: Eligible very low risk or standard risk patients

Probability of being alive after 4 years in the study.

Outcome measures

Measure	Very Low Risk n=116 Participants Very Low Risk	Standard Risk, Stage I or II, With LOH n=32 Participants Standard Risk, Stage I or II, with LOH	Standard Risk, Stage III n=535 Participants Standard Risk, Stage III
Overall Survival (OS) Probability	1.00 Probability Interval 1.0 to 1.0	1.00 Probability Interval 1.0 to 1.0	0.97 Probability Interval 0.95 to 0.99

SECONDARY outcome

Timeframe: During follow-up

Population: Very low risk patients treated by nephrectomy and observation only.

Number of contralateral kidney lesions during follow-up.

Outcome measures

Measure	Very Low Risk n=116 Participants Very Low Risk	Standard Risk, Stage I or II, With LOH Standard Risk, Stage I or II, with LOH	Standard Risk, Stage III Standard Risk, Stage III
Incidence of Contralateral Kidney Lesions	1 Lesions	—	—

SECONDARY outcome

Timeframe: During follow-up

Population: Very low risk patients that have metachronous relapse.

Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up

Outcome measures

Measure	Very Low Risk n=116 Participants Very Low Risk	Standard Risk, Stage I or II, With LOH Standard Risk, Stage I or II, with LOH	Standard Risk, Stage III Standard Risk, Stage III
Incidence of Renal Failure	0 Incidents	—	—

Adverse Events

Very Low Risk Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Risk, Stage I or II, no LOH

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Risk, Stage I or II, With LOH

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Risk, Stage III

Serious events: 20 serious events

Other events: 31 other events

Deaths: 0 deaths

High Risk

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Very Low Risk Disease n=116 participants at risk Nephrectomy and Re-evaluation	Low Risk, Stage I or II, no LOH n=51 participants at risk Low risk, stage I or II, no loss of heterozygosity (LOH).	Standard Risk, Stage I or II, With LOH n=32 participants at risk Standard Risk, Stage I or II, with loss of heterozygosity (LOH).	Standard Risk, Stage III n=535 participants at risk Nephrectomy/Biopsy, Chemotherapy	High Risk n=40 participants at risk High risk.
General disorders 24600-Death NOS	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	1.9% 10/535 • Number of events 10 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Gastrointestinal disorders 36700-Gastrointestinal disorders - Other specify	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
General disorders 37200-General disorders and administration site conditions	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Hepatobiliary disorders 40000-Hepatic failure	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 51900-Leukemia secondary to oncology chemotherapy	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
General disorders 55700-Multi-organ failure	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 58000-Neoplasms benign malignant and unspecified (incl cy	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.56% 3/535 • Number of events 3 Adverse Events were reported for eligible patients only.	2.5% 1/40 • Number of events 1 Adverse Events were reported for eligible patients only.
Nervous system disorders 73600-Seizure	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Infections and infestations 73700-Sepsis	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.37% 2/535 • Number of events 3 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Gastrointestinal disorders 75700-Small intestinal obstruction	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.

Other adverse events

Measure	Very Low Risk Disease n=116 participants at risk Nephrectomy and Re-evaluation	Low Risk, Stage I or II, no LOH n=51 participants at risk Low risk, stage I or II, no loss of heterozygosity (LOH).	Standard Risk, Stage I or II, With LOH n=32 participants at risk Standard Risk, Stage I or II, with loss of heterozygosity (LOH).	Standard Risk, Stage III n=535 participants at risk Nephrectomy/Biopsy, Chemotherapy	High Risk n=40 participants at risk High risk.
Investigations 11600-Alanine aminotransferase increased	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.93% 5/535 • Number of events 6 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Gastrointestinal disorders 14900-Ascites	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.37% 2/535 • Number of events 2 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Investigations 15000-Aspartate aminotransferase increased	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	1.1% 6/535 • Number of events 6 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Blood and lymphatic system disorders 33300-Febrile neutropenia	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
General disorders 33900-Fever	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Gastrointestinal disorders 36400-Gastritis	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Hepatobiliary disorders 40600-Hepatobiliary disorders - Other specify	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Metabolism and nutrition disorders 41400-Hyperglycemia	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 2 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Metabolism and nutrition disorders 41600-Hyperkalemia	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Metabolism and nutrition disorders 42500-Hyperuricemia	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.37% 2/535 • Number of events 2 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Metabolism and nutrition disorders 42700-Hypocalcemia	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Metabolism and nutrition disorders 42900-Hypoglycemia	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.37% 2/535 • Number of events 2 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Metabolism and nutrition disorders 43100-Hypokalemia	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	1.3% 7/535 • Number of events 8 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Vascular disorders 43600-Hypotension	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Infections and infestations 44800-Infections and infestations - Other specify	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.37% 2/535 • Number of events 4 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Injury, poisoning and procedural complications 47000-Intraoperative gastrointestinal injury	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Investigations 58300-Neutrophil count decreased	0.00% 0/116 Adverse Events were reported for eligible patients only.	2.0% 1/51 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	1.3% 7/535 • Number of events 9 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Injury, poisoning and procedural complications 66800-Postoperative hemorrhage	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Renal and urinary disorders 71300-Renal hemorrhage	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Respiratory, thoracic and mediastinal disorders 71500-Respiratory failure	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.37% 2/535 • Number of events 2 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Respiratory, thoracic and mediastinal disorders 71600-Respiratory thoracic and mediastinal disorders - Ot	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Infections and infestations 73700-Sepsis	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Gastrointestinal disorders 75700-Small intestinal obstruction	0.00% 0/116 Adverse Events were reported for eligible patients only.	2.0% 1/51 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.00% 0/535 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Vascular disorders 79600-Thromboembolic event	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.37% 2/535 • Number of events 2 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.
Gastrointestinal disorders 87900-Vomiting	0.00% 0/116 Adverse Events were reported for eligible patients only.	0.00% 0/51 Adverse Events were reported for eligible patients only.	0.00% 0/32 Adverse Events were reported for eligible patients only.	0.19% 1/535 • Number of events 1 Adverse Events were reported for eligible patients only.	0.00% 0/40 Adverse Events were reported for eligible patients only.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: resultsreportingcoordinator@childrensoncologygroup.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER