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Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

NCT00002995 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 483

Last updated 2014-02-14

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy work in 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 chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.

Conditions

  • Sarcoma

Interventions

BIOLOGICAL

dactinomycin

BIOLOGICAL

filgrastim

BIOLOGICAL

sargramostim

DRUG

cyclophosphamide

DRUG

vincristine sulfate

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • R. Beverly Raney, MD · M.D. Anderson Cancer Center

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-08-31
Primary Completion
2006-09-30
Completion
2011-01-31

Countries

  • United States
  • Australia
  • Canada
  • Netherlands
  • 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 NCT00002995 on ClinicalTrials.gov