ProjectFAR-RMS – FRONTLINE AND RELAPSED RHABDOMYOSARCOMA: FAR-RMS clinical trial. EudraCT Nr. 2018-000515-24;…
Basic data
Acronym:
FAR-RMS
Title:
FRONTLINE AND RELAPSED RHABDOMYOSARCOMA: FAR-RMS clinical trial. EudraCT Nr. 2018-000515-24; ClinicalTrials.gov Identifier: NCT04625907
Duration:
15/07/2024 to 15/07/2029
Abstract / short description:
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)
Keywords:
medicine
Medizin
clinical trial
klinische Studie
oncology
Onkologie
pediatrics
Pädiatrie
Involved staff
Managers
Faculty of Medicine
University of Tübingen
University of Tübingen
Faculty of Medicine
University of Tübingen
University of Tübingen
University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Contact persons
Faculty of Medicine
University of Tübingen
University of Tübingen
Other staff
Faculty of Medicine
University of Tübingen
University of Tübingen
Universität Tübingen
Faculty of Medicine
University of Tübingen
University of Tübingen
Local organizational units
Paediatrics Department I and Polyclinic
University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Department VIII, Medical Oncology and Pulmonology
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Department of Paediatric Surgery and Paediatric Urology and Polyclinic
University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Department of Diagnostic and Interventional Radiology
Department of Radiology
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Department of Radiation Oncology
Hospitals and clinical institutes
Faculty of Medicine
Faculty of Medicine
Funders
Bonn, Nordrhein-Westfalen, Germany
Cooperations
Birmingham, United Kingdom
Utrecht, Netherlands