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Clinical trialNCT00354835CompletedPhase 3Interventional

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

SponsorChildren's Oncology GroupEnrollment481Adult RhabdomyosarcomaChildhood Alveolar RhabdomyosarcomaChildhood Botryoid-Type Embryonal RhabdomyosarcomaChildhood Embryonal RhabdomyosarcomaLocalized Childhood Soft Tissue SarcomaRhabdomyosarcoma+4 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

226 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Sydney Children'S Hospital

    Randwick, New South Wales, Australia

  • the Children'S Hospital at Westmead

    Westmead, New South Wales, Australia

  • Westmead Hospital

    Westmead, New South Wales, Australia

  • Royal Brisbane and Women'S Hospital

    Herston, Queensland, Australia

  • Royal Children'S Hospital-Brisbane

    Herston, Queensland, Australia

  • Queensland Children'S Hospital

    South Brisbane, Queensland, Australia

  • Women'S and Children'S Hospital-Adelaide

    North Adelaide, South Australia, Australia

  • Royal Children'S Hospital

    Parkville, Victoria, Australia

  • Princess Margaret Hospital for Children

    Perth, Western Australia, Australia

Canada
  • Alberta Children'S Hospital

    Calgary, Alberta, Canada

  • University of Alberta Hospital

    Edmonton, Alberta, Canada

  • British Columbia Children'S Hospital

    Vancouver, British Columbia, Canada

  • Cancercare Manitoba

    Winnipeg, Manitoba, Canada

  • Janeway Child Health Centre

    St. John's, Newfoundland and Labrador, Canada

  • Iwk Health Centre

    Halifax, Nova Scotia, Canada

  • Mcmaster Children'S Hospital at Hamilton Health Sciences

    Hamilton, Ontario, Canada

  • Kingston Health Sciences Centre

    Kingston, Ontario, Canada

  • Children'S Hospital

    London, Ontario, Canada

  • Victoria Hospital

    London, Ontario, Canada

  • Children'S Hospital of Eastern Ontario

    Ottawa, Ontario, Canada

  • Hospital for Sick Children

    Toronto, Ontario, Canada

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, Canada

  • the Montreal Children'S Hospital of the Muhc

    Montreal, Quebec, Canada

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, Canada

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, Canada

  • Centre Hospitalier Universitaire de Quebec

    Québec, Canada

New Zealand
  • Starship Children'S Hospital

    Grafton, Auckland, New Zealand

Puerto Rico
  • San Jorge Children'S Hospital

    San Juan, Puerto Rico

Switzerland
  • Swiss Pediatric Oncology Group - Bern

    Bern, Switzerland

  • Swiss Pediatric Oncology Group - Geneva

    Geneva, Switzerland

United States
  • Children'S Hospital of Alabama

    Birmingham, Alabama, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States

  • Phoenix Childrens Hospital

    Phoenix, Arizona, United States

  • Banner University Medical Center - Tucson

    Tucson, Arizona, United States

  • Arkansas Children'S Hospital

    Little Rock, Arkansas, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States

  • Kaiser Permanente Downey Medical Center

    Downey, California, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, United States

  • Loma Linda University Medical Center

    Loma Linda, California, United States

  • Miller Children'S and Women'S Hospital Long Beach

    Long Beach, California, United States

186 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cyclophosphamide →DactinomycinIrinotecan →Vincristine →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
26 Dec 2006
Primary completion
31 Dec 2014
Completion
31 Dec 2022
Last update posted
31 Jan 2023
Registered enrollment
481
Registry id
NCT00354835
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.