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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 808

Last updated 2026-02-18

Study results available
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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.

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Elizabeth A Mullen · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-06
Primary Completion
2014-12-31
Completion
2026-03-31

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • New Zealand
  • Puerto Rico
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00352534 on ClinicalTrials.gov