A Randomized Phase III Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients with Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma
Categories (click each to see list of all clinical trials associated with that category): Child Health Research Institute (CHRIONC), Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07466316?term=NCT07466316&viewType=Card&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To determine if the event free survival (EFS) of patients with intermediate risk rhabdomyosarcoma (IR RMS) treated with surgery, radiotherapy, and vincristine, dactinomycin, cyclophosphamide (VAC) (2.2 g/m^2/cycle cyclophosphamide) chemotherapy (regimen A) is better than that of patients treated with surgery, radiotherapy, and VAC alternating with vincristine, irinotecan (VI) (VAC/VI) (1.2 g/m^2/cycle cyclophosphamide) chemotherapy plus 24 weeks of maintenance chemotherapy with vinorelbine and cyclophosphamide (regimen B).
SECONDARY OBJECTIVES:
I. To determine if the overall survival (OS) of patients with IR RMS treated with surgery and/or radiotherapy, and VAC (2.2 g/m^2/cycle cyclophosphamide) chemotherapy (regimen A) is better than the OS of patients treated with surgery, radiotherapy, and VAC alternating with VI (VAC/VI) (1.2 g/m^2/cycle cyclophosphamide) plus 24 weeks of maintenance chemotherapy with vinorelbine and cyclophosphamide (regimen B).
II. To compare clinician-reported treatment-related adverse event (AE) rates between two regimens.
III. To assess the feasibility of real-time central surgical review conducted by the study team radiologists, surgeons, and radiation oncologists to determine eligibility for delayed primary excision (DPE) after week 9 imaging, and to then determine the proportion of patients deemed eligible for DPE on central review who undergo DPE.
IV. To compare the 4-year local failure (LF) rate of patients deemed DPE-eligible by central surgical review who undergo DPE with the 4-year LF rate of patients deemed DPE-eligible by central surgical review who do not undergo DPE.
V. To determine the feasibility of reporting diagnostic tumor molecular features identified via the Molecular Characterization Initiative (MCI) within 6 weeks of treatment initiation for clinical group III patients.