FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

  • STATUS
    Recruiting
  • End date
    Jun 26, 2030
  • participants needed
    1672
  • sponsor
    University of Birmingham
Updated on 26 January 2021

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 IdentifierNCT04625907
SponsorUniversity of Birmingham
Last Modified on26 January 2021

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