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Study identifier: NCT07466316 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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)

Condition: Rhabdomyosarcoma  ·  Sponsor: Children's Oncology Group

PhasePhase 3
Planned participants342
Who can joinAll sexes, N/A to 50 Years
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (65)

Mattel Children's Hospital UCLALos Angeles, California, United StatesRecruiting
Valley Children's HospitalMadera, California, United StatesRecruiting
Kaiser Permanente-OaklandOakland, California, United StatesRecruiting
Children's Hospital of Orange CountyOrange, California, United StatesRecruiting
Children's Hospital ColoradoAurora, Colorado, United StatesRecruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenver, Colorado, United StatesRecruiting
Connecticut Children's Medical CenterHartford, Connecticut, United StatesRecruiting
Alfred I duPont Hospital for ChildrenWilmington, Delaware, United StatesRecruiting
Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, Florida, United StatesRecruiting
Nemours Children's Clinic-JacksonvilleJacksonville, Florida, United StatesRecruiting
Nemours Children's HospitalOrlando, Florida, United StatesRecruiting
Nemours Children's Clinic - PensacolaPensacola, Florida, United StatesRecruiting

+ 53 more locations — full list on the registry record.

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