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A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma

Trial comparing vinorelbine and maintenance therapy for high-risk rhabdomyosarcoma.

Recruiting
50 years and younger
All
Phase 3

Study Overview: This research is for patients with high-risk rhabdomyosarcoma (RMS), a type of cancer. The study looks at whether adding a drug called vinorelbine to standard chemotherapy (vincristine, dactinomycin, and cyclophosphamide) and using maintenance therapy can help prevent the cancer from returning. High-risk means the cancer is more likely to come back or spread after treatment. Vinorelbine and vincristine are vinca alkaloids, which stop cancer cells from growing. Dactinomycin and cyclophosphamide damage the DNA in cancer cells, potentially killing them.

  • Study Length: The study involves up to 14 cycles of treatment, with each cycle lasting 21 days, and an additional maintenance period of 24 weeks.
  • Eligibility: Patients under 50 years with newly diagnosed high-risk RMS are eligible. Certain health conditions and previous treatments may disqualify participants.
  • Follow-up Visits: After treatment, patients have regular follow-ups every few months for 5 years to monitor their health.
Study details
    Alveolar Rhabdomyosarcoma
    Botryoid-Type Embryonal Rhabdomyosarcoma
    Embryonal Rhabdomyosarcoma
    Metastatic Embryonal Rhabdomyosarcoma
    Metastatic Rhabdomyosarcoma
    Solid Alveolar Rhabdomyosarcoma
    Spindle Cell Rhabdomyosarcoma
    Spindle Cell/Sclerosing Rhabdomyosarcoma

NCT04994132

Children's Oncology Group

17 December 2024

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