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FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)
Details
| Lead sponsor | University of Birmingham |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 1672 |
| Start date | 2020-09-17 |
| Completion | 2030-06 |
Conditions
- Rhabdomyosarcoma
Interventions
- Irinotecan
- Actinomycin D
- Doxorubicin
- Ifosfamide
- Vincristine
- Vinorelbine
- Cyclophosphamide
- Temozolomide
- radiotherapy
- Regorafenib
Primary outcomes
- Event Free Survival (RT2) — From randomisation to first failure event, timeframe 36 months
Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm - Event Free Survival (CT1A) — From randomisation to first failure event, timeframe 36 months
Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm - Event Free Survival (CT1B) — From randomisation to first failure event, timeframe 36 months
Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm - Event Free Survival (CT2A) — From randomisation to first failure event, timeframe 36 months
Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm - Event Free Survival (CT2B) — Time from randomisation to first failure event, timeframe 36 months
Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm - Event Free Survival (CT3) — Patients will be followed up for a minimum of 6 years from trial entry (or 5 years from end of relapsed trial treatment, whichever comes later). Patients will be followed up for progression and death until the end of trial definition has been met.
To determine whether new systemic therapy regimens improve event free survival in relapsed RMS compared to standard therapy (VIRT) (CT3): Initial new systemic therapy combination to be tested: o Regorafenib (R) added to vincristine and irinotecan (VIR) (VIRR)
Countries
Australia, Austria, Belgium, Czechia, Denmark, France, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom