FAR-RMS

FRONTLINE AND RELAPSED RHABDOMYOSARCOMA: FAR-RMS clinical trial. EudraCT Nr. 2018-000515-24; ClinicalTrials.gov Identifier: NCT04625907

15.07.2024 bis 15.07.2029

FaR-RMS is an overarching study for patients with newly diagnosed and relapsed RMS including multi-arm, multi-stage questions with four principal aims. Primary objectives: 1. Frontline chemotherapy questions for the most advanced disease states high risk (HR) and very high risk group (VHR): to compare standard chemotherapy (CHT) regimen with addition of irinotecan as new agent 2. Radiotherapy (RT) questions to improve local control in Standard Risk (SR), HR and VHR patients: to compare pre- versus postoperative RT, standard dose versus dose escalation, and RT of all metastases versus primary tumour and lymph nodes only 3. Maintenance chemotherapy questions: to compare standard duration for HR/ VHR of 6/ 12 months versus 12/24 months, respectively 4. Relapsed RMS question: to compare standard CHT with addition of regorafenib Secondary Objectives: 1. Risk stratification by use of PAX-FOXO1 fusion gene status instead of histology 2. Use of FDG PET-CT response assessment as a prognostic biomarker for outcome (Germany will not take part in this question)