MedTrace Logo

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

NCT00379340 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2026-03-17

Study results available
· View outcomes & findings →

Summary

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Conditions

  • Stage III Kidney Wilms Tumor
  • Stage IV Kidney Wilms Tumor

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

PROCEDURE

Conventional Surgery

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Vincristine Sulfate Liposome

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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2016-06-30
Completion
2026-11-18

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT00379340 on ClinicalTrials.gov