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Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

NCT00945009 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2025-05-31

Study results available
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Summary

This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

Conditions

  • Adult Kidney Wilms Tumor
  • Beckwith-Wiedemann Syndrome
  • Childhood Kidney Wilms Tumor
  • Diffuse Hyperplastic Perilobar Nephroblastomatosis
  • Rhabdoid Tumor of the Kidney
  • Stage I Kidney Wilms Tumor
  • Stage II Kidney Wilms Tumor
  • Stage III Kidney Wilms Tumor
  • Stage IV Kidney Wilms Tumor
  • Stage V Kidney Wilms Tumor

Interventions

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Peter F Ehrlich · 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
2009-07-13
Primary Completion
2016-12-31

Countries

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

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 NCT00945009 on ClinicalTrials.gov