FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
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- STATUS
- Recruiting
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- End date
- Jun 26, 2030
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- participants needed
- 1672
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- sponsor
- University of Birmingham
Summary
FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)
Description
FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS). It is a multi-arm, multi-stage format, involving several different trial questions. FaR-RMS is intended to be a rolling programme of research with new treatment arms being introduced dependant on emerging data and innovation. This study has multiple aims. It aims to evaluate the impact of new agent regimens in both newly diagnosed and relapsed RMS whether changing the duration of maintenance therapy affects outcome and whether changes to dose, extent (in metastatic disease) and timing of radiotherapy improve outcome and quality of life. In addition the study will evaluate risk stratification through the use of PAX-FOXO1 fusion gene status instead of histological subtyping and explore the use of FDG PET-CT response assessment as a prognostic biomarker for outcome following induction chemotherapy.
Newly diagnosed patients should, where possible, be entered into the FaR-RMS study at the time of first diagnosis prior to receiving any chemotherapy. However, patients can enter at the point of radiotherapy or maintenance, and those with relapsed disease can enter the study even if not previously entered at initial diagnosis. Patients may be entered into more than one randomisation/registration, dependant on patient risk group and disease status.
Details
| Condition | Rhabdomyosarcoma, Rhabdomyosarcoma |
|---|---|
| Treatment | cyclophosphamide, ifosfamide, Radiotherapy, Temozolomide, Irinotecan, vincristine, doxorubicin, Vinorelbine, actinomycin D |
| Clinical Study Identifier | NCT04625907 |
| Sponsor | University of Birmingham |
| Last Modified on | 26 January 2021 |
Eligibility
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