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

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)

  • Clinical Trial Information

    Trial Contact: Parker, Melanie; Spinelli, Jennifer; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D

  • IRB No: ARST2031

    Protocol Abbrev: ARST2031

    Principal Investigator:

    Phase: Drug: Phase III

    Age Group: Adult;Pediatric

    Secondary Protocol No: ARST2031

    Treatment: Drug: Cyclophosphamide, Biological: Dactinomycin, Radiation: Radiation Therapy, Drug: Vincristine Sulfate, Drug: Vinorelbine Tartrate

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT04994132

  • Objective

    To compare event-free survival (EFS) of patients with high-risk rhabdomyosarcoma (HR-RMS) treated with vinorelbine, dactinomycin and cyclophosphamide (VINO AC) followed by 24 weeks of vinorelbine and oral cyclophosphamide (VINO-CPO) maintenance therapy to that of patients treated with vincristine, dactinomycin and cyclophosphamide (VAC) followed by 24 weeks of VINO-CPO maintenance therapy.

  • Key Eligibility

    Ages Eligible for Study: up to 50 Years (Child, Adult)
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No
    Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification are eligible to enroll on the study based upon Stage, Group, and age