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NCT00352534

PHASE3

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

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

Summary

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.

Official title: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Key Details

Gender

All

Age Range

Any - 29 Years

Study Type

INTERVENTIONAL

Enrollment

808

Start Date

2006-11-06

Completion Date

2026-03-31

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Stage I Kidney Wilms Tumor Stage II Kidney Wilms Tumor Stage III Kidney Wilms Tumor

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Patients undergo radiotherapy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Chest Radiography

Undergo chest X-ray

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

PROCEDURE

Ultrasound Imaging

Undergo ultrasound

DRUG

Vincristine Sulfate

Given IV

Inclusion Criteria: * 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 * Stage II disease * Age \< 30 years * Any tumor weight * Disease requires radiotherapy * No LOH at chromosomes 1p and 16q\* * Stage III disease * Must be enrolled on protocol COG-AREN03B2 * Karnofsky performance status (PS) 50-100% for patients \> 16 years old * Lansky PS 50-100% for patients ≤ 16 years old * Bilirubin (direct) ≤ 1.5 times upper limit of normal (ULN) * AST or ALT \< 2.5 times ULN * Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram (standard-risk disease) * Not pregnant or nursing * Negative pregnancy test * Fertile patient must use effective contraception * No prior tumor-directed chemotherapy or radiotherapy * Patients transferring from AREN03B2 with LOH 1p and 16q allowed

Locations (240)

Children's Hospital of Alabama

Birmingham, Alabama, United States

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

Harbor-University of California at Los Angeles Medical Center

Torrance, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

University of Connecticut

Farmington, Connecticut, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Lee Memorial Health System

Fort Myers, Florida, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

AdventHealth Orlando