Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma
-
Clinical Trial Information
Trial Contact: Armatti, Julie M; Parker, Melanie; Frankos, Marie; Torrescano, Tanner
Trial Phone: 321-843-5284 ; 321-843-1036 ; 321-842-8738 ; 321-841-8271
-
IRB No: ARST2032
Protocol Abbrev: ARST2032
Principal Investigator: Jaime C Gonzalez, MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: ARST2032
Treatment: Drug: Cyclophosphamide, Biological: Dactinomycin, Radiation: Radiation Therapy, Drug: Vincristine
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05304585
-
Objective
To maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma.
-
Key Eligibility
- must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).
- must be =< 21 years at the time of enrollment.
- newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant).
- Enrollment in APEC14B1 is required for all patients.
