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Recruiting Phase 3 Interventional

A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)

ClinicalTrials.gov ID: NCT07466316

Public ClinicalTrials.gov record NCT07466316. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 7:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.

Study identification

NCT ID
NCT07466316
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Children's Oncology Group
Network
Enrollment
342 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 13, 2026
Primary completion
Mar 30, 2031
Completion
Mar 30, 2031
Last update posted
Aug 24, 2026

2026 – 2031

United States locations

U.S. sites
86
U.S. states
33
U.S. cities
74
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 Recruiting
USA Health Strada Patient Care Center Mobile Alabama 36604 Recruiting
Arkansas Children's Hospital Little Rock Arkansas 72202-3591 Recruiting
City of Hope Comprehensive Cancer Center Duarte California 91010 Recruiting
Loma Linda University Medical Center Loma Linda California 92354 Recruiting
Cedars-Sinai Medical Center Los Angeles California 90048 Recruiting
Mattel Children's Hospital UCLA Los Angeles California 90095 Recruiting
Valley Children's Hospital Madera California 93636 Recruiting
Kaiser Permanente-Oakland Oakland California 94611 Recruiting
Children's Hospital of Orange County Orange California 92868 Recruiting
Children's Hospital Colorado Aurora Colorado 80045 Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218 Recruiting
Connecticut Children's Medical Center Hartford Connecticut 06106 Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware 19803 Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida 33021 Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207 Recruiting
Nemours Children's Hospital Orlando Florida 32827 Recruiting
Nemours Children's Clinic - Pensacola Pensacola Florida 32504 Recruiting
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 Recruiting
Saint Mary's Medical Center West Palm Beach Florida 33407 Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329 Recruiting
Lurie Children's Hospital-Chicago Chicago Illinois 60611 Recruiting
University of Illinois Chicago Illinois 60612 Recruiting
Riley Hospital for Children Indianapolis Indiana 46202 Recruiting
Blank Children's Hospital Des Moines Iowa 50309 Recruiting
Wesley Medical Center Wichita Kansas 67214 Recruiting
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536 Not yet recruiting
Norton Children's Hospital Louisville Kentucky 40202 Recruiting
MaineHealth Coastal Cancer Treatment Center Bath Maine 04530 Recruiting
MaineHealth Maine Medical Center - Portland Portland Maine 04102 Recruiting
MaineHealth Cancer Care Center of York County Sanford Maine 04073 Recruiting
Maine Children's Cancer Program Scarborough Maine 04074 Recruiting
MaineHealth Maine Medical Center- Scarborough Scarborough Maine 04074 Recruiting
Sinai Hospital of Baltimore Baltimore Maryland 21215 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
UMass Memorial Medical Center - University Campus Worcester Massachusetts 01655 Recruiting
Bronson Battle Creek Battle Creek Michigan 49017 Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan 49503 Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503 Recruiting
Trinity Health Grand Rapids Hospital Grand Rapids Michigan 49503 Recruiting
Bronson Methodist Hospital Kalamazoo Michigan 49007 Recruiting
West Michigan Cancer Center Kalamazoo Michigan 49007 Recruiting
Beacon Kalamazoo Kalamazoo Michigan 49048 Recruiting
Trinity Health Muskegon Hospital Muskegon Michigan 49444 Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan 49120 Recruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan 49444 Suspended
Corewell Health Reed City Hospital Reed City Michigan 49677 Recruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan 49085 Recruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan 49085 Recruiting
Munson Medical Center Traverse City Michigan 49684 Recruiting
University of Michigan Health - West Wyoming Michigan 49519 Recruiting
University of Mississippi Medical Center Jackson Mississippi 39216 Recruiting
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 Recruiting
Mercy Hospital Saint Louis St Louis Missouri 63141 Recruiting
Children's Hospital and Medical Center of Omaha Omaha Nebraska 68114 Recruiting
University of Nebraska Medical Center Omaha Nebraska 68198 Recruiting
Renown Regional Medical Center Reno Nevada 89502 Recruiting
Albany Medical Center Albany New York 12208 Recruiting
University of Rochester Rochester New York 14642 Recruiting
Montefiore Medical Center - Moses Campus The Bronx New York 10467 Recruiting
Mission Hospital Asheville North Carolina 28801 Recruiting
Children's Hospital Medical Center of Akron Akron Ohio 44308 Recruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio 43606 Recruiting
Legacy Emanuel Children's Hospital Portland Oregon 97227 Recruiting
Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania 18103 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
Saint Christopher's Hospital for Children Philadelphia Pennsylvania 19134 Recruiting
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 Recruiting
Rhode Island Hospital Providence Rhode Island 02903 Recruiting
East Tennessee Childrens Hospital Knoxville Tennessee 37916 Recruiting
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203 Recruiting
Dell Children's Medical Center of Central Texas Austin Texas 78723 Recruiting
Driscoll Children's Hospital Corpus Christi Texas 78411 Recruiting
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 Recruiting
Methodist Children's Hospital of South Texas San Antonio Texas 78229 Recruiting
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 Recruiting
Primary Children's Hospital Salt Lake City Utah 84113 Recruiting
University of Virginia Cancer Center Charlottesville Virginia 22908 Recruiting
Inova Fairfax Hospital Falls Church Virginia 22042 Recruiting
Children's Hospital of The King's Daughters Norfolk Virginia 23507 Recruiting
Seattle Children's Hospital Seattle Washington 98105 Recruiting
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405 Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison Wisconsin 53718 Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 Recruiting
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07466316, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 24, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07466316 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →