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) (NCT07466316)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: Not specified to 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (87 Sites)
Showing the first 25 of 87 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- USA Health Strada Patient Care Center — Mobile, Alabama
- Arkansas Children's Hospital — Little Rock, Arkansas
- City of Hope Comprehensive Cancer Center — Duarte, California
- Loma Linda University Medical Center — Loma Linda, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Mattel Children's Hospital UCLA — Los Angeles, California
- Valley Children's Hospital — Madera, California
- Kaiser Permanente-Oakland — Oakland, California
- Children's Hospital of Orange County — Orange, California
- Children's Hospital Colorado — Aurora, Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
- Alfred I duPont Hospital for Children — Wilmington, Delaware
- Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida
- Nemours Children's Hospital — Orlando, Florida
- Nemours Children's Clinic - Pensacola — Pensacola, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida
- Saint Mary's Medical Center — West Palm Beach, Florida
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia
- Lurie Children's Hospital-Chicago — Chicago, Illinois
- University of Illinois — Chicago, Illinois
- Riley Hospital for Children — Indianapolis, Indiana
📞 Contact the Study Coordinator
Phone: (205) 638-9285
Email: oncologyresearch@peds.uab.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rhabdomyosarcoma
- Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy — Jacksonville, Florida
- Evolutionary Therapy for Rhabdomyosarcoma — Birmingham, Alabama
- Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma — Los Angeles, California
- Analyzing Engagement Trends in Rhabdomyosarcoma Clinical Trials — San Francisco, California
- Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE) — Washington D.C., District of Columbia
- FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma — Bethesda, Maryland
Explore by condition: All Rhabdomyosarcoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.