FaR-RMS
Author: CWS-Study group, Last modification: 2025/06/19 https://kinderkrebsinfo.de/doi/e283457
FaR-RMS | An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma |
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Disease | Rhabdomyosarkoma |
Type | Prospective, international, multicentre trial: Phase 1b for new agents, Phase 3 for randomized questions |
Rationale / Objectives |
FaR-RMS is an over-arching study for patients with newly diagnosed and relapsed RMS including multi-arm, multi-stage questions with three principal aims. These are to evaluate: |
Therapy / Study arms |
FaR-RMS is intended to be a rolling programme of research with new treatment arms being introduced dependant on emerging data and innovation, provided it is within the pre-defined research remit of the trial.
Phase I Dose Finding Studies
Frontline Chemotherapy
Radiotherapy (VHR, HR, SR)
Maintenance Chemotherapy
Relapsed RMS |
Inclusion Criteria |
Inclusion Criteria for study entry – Mandatory at first point of study entry
The eligibility for the different study arms should be checked in the actual protocol version. |
Recruitment | Frontline: A minimum of 840 patients with newly diagnosed RMS; Relapse: A minimum 260 patients with relapsed/recurrent RMS |
Status | Timeline: Start: 2025, Recruitment over 7 years, additional observation phase 3-6 years |
EudraCT | 2018-000515-24 |
Entry Study Register |
ClinicalTrials.gov:
NCTNCT04625907
|
Principal Investigator | Prof. Dr. med. M. Sparber-Sauer for Germany |
Contact |
Principal Investigator GermanyProf. Dr. med. Monika Sparber-Sauer Olgahospital Kinder- und Jugendmedizin Kriegsbergstr. 62 70174 Stuttgart Telefon +49 (0) 711 278 73 870 m.sparber@klinikum-stuttgart.de Documentation and DatamanagementCWS-Studiendokumentation Klinikum Stuttgart - Standort Mitte (Olgahospital) Klinik für Kinder,- Jugend- und Frauenmedizin, Pädiatrie 5 Kriegsbergstr. 62 70174 Stuttgart Telefon +49 (711) 992 3870 Fax +49 (711) 992 2749 cws@klinikum-stuttgart.de |
Sponsoring | Coordinating Sponsor: University of Birmingham |