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)
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Clinical Trial Information
Trial Contact: Parker, Melanie; Spinelli, Jennifer; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321-843-1036 ; 321.841.5357 ; 321-843-5284 ; 3218412008 ; 321-841-7561
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IRB No: ARST2031
Protocol Abbrev: ARST2031
Principal Investigator: Amy A. Smith, MD
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
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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.
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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
