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Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer

NCT00002611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3031

Last updated 2021-02-25

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer.

PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.

Conditions

Interventions

BIOLOGICAL

dactinomycin

BIOLOGICAL

filgrastim

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

Source and Pharmacology: An anthracycline antibiotic isolated from cultures of Streptomyces peucetius. Binds to DNA and inhibits nucleic acid synthesis, with its major lethal effect occurring during the S phase of the cell cycle. Has some topoisomerase II inhibitory activity. Since it is primarily excreted by the liver, any liver impairment may enhance toxicity. 40% to 50% is excreted in the bile; \<5% in the urine. The drug has a very short initial t½ of \<20 minutes and a terminal t½ of 17 hours. Animal studies indicate cytotoxic levels persist in tissue for as long as 24 hours.

DRUG

etoposide

DRUG

vincristine sulfate

PROCEDURE

conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Daniel M. Green, MD · Roswell Park Cancer Institute

Study Design

Purpose
TREATMENT

Eligibility

Min Age
0 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-07-31
Primary Completion
2002-06-30
Completion
2003-08-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00002611 on ClinicalTrials.gov