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Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

NCT00354835 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2023-01-31

Study results available
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Summary

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, 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 combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.

Conditions

  • Adult Rhabdomyosarcoma
  • Childhood Alveolar Rhabdomyosarcoma
  • Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
  • Childhood Embryonal Rhabdomyosarcoma
  • Localized Childhood Soft Tissue Sarcoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Stage I Adult Soft Tissue Sarcoma AJCC v7
  • Stage II Adult Soft Tissue Sarcoma AJCC v7
  • Stage III Adult Soft Tissue Sarcoma AJCC v7

Interventions

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiotherapy

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Douglas S Hawkins · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-26
Primary Completion
2014-12-31
Completion
2022-12-31

Countries

  • United States
  • Australia
  • Canada
  • 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 NCT00354835 on ClinicalTrials.gov