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Protocol Summary


Protocol No.
PSCI-21-202
Prinicipal Investigator
McGregor, Lisa
Phase
Phase III
Age Group
Children
Scope
National
Secondary Protocol No.
ARST2031
Title
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)
Objective
Primary Aim: To compare event-free survival (EFS) of patients with HR-RMS treated with VINO-AC followed by 24 weeks of VINO-CPO maintenance therapy to that of patients treated with VAC followed by 24 weeks of VINO-CPO maintenance therapy.

Secondary Aims: To assess the safety and feasibility of administering VINO-AC in newly diagnosed patients with HR-RMS. To describe the toxicity experience of patients with HR-RMS treated with VINOAC compared to VAC.To compare overall survival (OS) of patients with HR-RMS treated with VINO-AC followed by 24 weeks of VINO-CPO maintenance therapy to that of patients treated with VAC followed by 24 weeks of VINO-CPO maintenance therapy. To compare objective radiologic response rates at Week 12 between patients with
HR-RMS treated with VINO-AC to those treated with VAC. To determine whether the addition of 24 weeks of VINO-CPO maintenance therapy improves EFS in patients with HR-RMS when compared to historical controls.
Applicable Disease Sites
Bones and Joints
Status
Open
Participating Institutions
Hershey Medical Center