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

Completed · Phase 3

Conditions studied: Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor

In brief

This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

Key facts

Study ID

NCT00352534

Run by

Children's Oncology Group

People needed

808

Starts

2006-11-06

Expected to finish

2026-03-31

Last updated by the study team

2026-06-03

Who can join

Age: any, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed Wilms' tumor
• Newly diagnosed stage I-III disease
• Favorable histology
• No moderate- or high-risk Wilms' predisposition syndromes
• Must meet 1 of the following disease stratification categories:
• Very low-risk disease
• Stage I disease
• Age < 2 years
• Tumor weight < 550 g
• Regional lymph nodes histologically negative (must have been sampled)
• No pulmonary metastases on CT scan of chest
• No synchronous bilateral Wilms tumors (Stage V)
• Not predisposed to develop bilateral Wilms tumors, defined as unilateral Wilms tumor and any of the following:
• Aniridia
• Beckwith-Wiedemann syndrome
• Simpson-Golabi-Behmel syndrome
• Denys-Drash syndrome or other associated genito-urinary anomalies
• Multicentric WT or unilateral WT with contralateral nephrogenic rest(s) in a child < 1 year of age
• Diffuse hyperplastic perilobar nephroblastomatosis
• Standard-risk disease meeting 1 of the following criteria:
• Disease does not require radiotherapy
• LOH at chromosomes 1p and 16q for stage I or II
• Stage I disease meeting 1 of the following criteria:
• Age ≥ 2 years to age < 30 years
• Tumor weight ≥ 500 g

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• USA Health Strada Patient Care Center — Mobile, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Children's Oncology Group — Oakland, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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