Clinical trialNCT05304585RecruitingPhase 3Interventional

Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

SponsorChildren's Oncology GroupEnrollment205Embryonal RhabdomyosarcomaFusion-Negative Alveolar RhabdomyosarcomaSpindle Cell/Sclerosing Rhabdomyosarcoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

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.

Josephine H Haduong
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

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

180 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
Draga Barbaric
Recruiting
the Children'S Hospital at Westmead
Westmead, New South Wales, Australia
Bhavna Padhye
Recruiting
Perth Children'S Hospital
Perth, Western Australia, Australia
Marianne B. Phillips
Recruiting

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
Victor A. Lewis
Recruiting
University of Alberta Hospital
Edmonton, Alberta, Canada
Sarah J. McKillop
Recruiting
British Columbia Children'S Hospital
Vancouver, British Columbia, Canada
Rebecca J. Deyell
Recruiting
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Stephanie M. Villeneuve
Recruiting
Iwk Health Centre
Halifax, Nova Scotia, Canada
Craig Erker
Recruiting
Hospital for Sick Children
Toronto, Ontario, Canada
Anita Villani
Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Monia Marzouki
Recruiting
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Stephanie Mourad
Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada
Josee Brossard
Recruiting
Chu de Quebec-Centre Hospitalier de L'Universite Laval (chul)
Québec, Canada
Bruno Michon
Recruiting

New Zealand

Starship Children'S Hospital
Grafton, Auckland, New Zealand
Mandy PohLui de Silva
Recruiting
Christchurch Hospital
Christchurch, New Zealand
Tristan Pettit
Recruiting

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Jamie M. Aye
Recruiting
Usa Health Strada Patient Care Center
Mobile, Alabama, United States
Hamayun Imran
Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Nawal Merjaneh
Recruiting
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Michael W. Bishop
Recruiting
Kaiser Permanente Downey Medical Center
Downey, California, United States
Robert M. Cooper
Recruiting
Loma Linda University Medical Center
Loma Linda, California, United States
Albert Kheradpour
Recruiting
Miller Children'S and Women'S Hospital Long Beach
Long Beach, California, United States
Jacqueline N. Casillas
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Leo Mascarenhas
Recruiting
Children'S Hospital Los Angeles
Los Angeles, California, United States
Sara Kreimer
Recruiting
Mattel Children'S Hospital Ucla
Los Angeles, California, United States
Satiro N. De Oliveira
Recruiting
Valley Children'S Hospital
Madera, California, United States
Ruetima Titapiwatanakun
Recruiting
Kaiser Permanente-Oakland
Oakland, California, United States
Aarati V. Rao
Recruiting
Ucsf Benioff Children'S Hospital Oakland
Oakland, California, United States
Jennifer G. Michlitsch
Recruiting
Children'S Hospital of Orange County
Orange, California, United States
Elyssa M. Rubin
Recruiting
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
Jay Michael S. Balagtas
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Marcio H. Malogolowkin
Recruiting
Naval Medical Center -San Diego
San Diego, California, United States
Yoko T. Udaka
Recruiting
Rady Children'S Hospital - San Diego
San Diego, California, United States
William D. Roberts
Recruiting
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Arun A. Rangaswami
Recruiting
Children'S Hospital Colorado
Aurora, Colorado, United States
Masanori Hayashi
Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke'S Medical Center
Denver, Colorado, United States
Florence Choo
Recruiting
Connecticut Children'S Medical Center
Hartford, Connecticut, United States
Michael S. Isakoff
Recruiting
Yale University
New Haven, Connecticut, United States
Farzana Pashankar
Recruiting
Alfred I Dupont Hospital for Children
Wilmington, Delaware, United States
Sridhi Patel
Recruiting
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Jeffrey S. Dome
Recruiting

140 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 →DactinomycinVincristine →

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: 4 Aug 2022
Primary completion: 30 Jun 2030
Completion: 30 Jun 2030
Last update posted: 5 May 2026
Registered enrollment: 205
Registry id: NCT05304585

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.