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

Trial comparing early Vinorelbine use and maintenance for high-risk rhabdomyosarcoma.

Recruiting
50 years and younger
All
Phase 3

This study looks at treating a type of cancer called rhabdomyosarcoma (RMS), which often comes back or spreads. It compares two groups of patients to see which treatment works better. One group receives a drug called vinorelbine along with other chemotherapy drugs: vincristine, dactinomycin, and cyclophosphamide. These drugs work by stopping cancer cells from growing and dividing. After initial treatment, patients may receive "maintenance therapy" to try and keep the cancer away. Maintenance therapy includes vinorelbine and cyclophosphamide. This study involves regular check-ups and imaging tests like CT or MRI scans to monitor progress. The trial aims to find the best way to keep RMS from returning or spreading.

  • Duration: The study involves regular treatment cycles over several months, followed by maintenance therapy.
  • Participation: Patients must be under 50 years old, with newly diagnosed RMS, and meet specific health criteria.
  • Follow-Up: Patients will be monitored for up to 5 years after treatment to assess long-term outcomes.
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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