About the Study

High Risk Rhabdomyosarcoma: A Study to Compare Early Use of Vinorelbine and Maintenance Therapy

This study is available for those 50 years old or younger who have been diagnosed with high-risk rhabdomyosarcoma (HR-RMS), a type of cancer that occurs in the soft tissues of the body like the muscles. This study looks at how well two different chemotherapy regimens work when given to children and adults with HR-RMS disease. Adding vinorelbine to one of the chemotherapy regimens is experimental because it has not yet been proven to work for those with HR-RMS. A computer will be assigning which treatment plan study participants will receive. This is called randomization. We also want to find out if we can improve the outcome for participants by extending the traditional treatment to include a treatment phase called maintenance therapy. All participants will receive maintenance therapy.

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Full Study Name: ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)