FaR-RMS
Research type
Research Study
Full title
FaR-RMS: An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma
IRAS ID
254931
Contact name
Meriel Jenney
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2018-000515-24
ISRCTN Number
ISRCTN45535982
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 11 months, 28 days
Research summary
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.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0145
Date of REC Opinion
16 Jul 2019
REC opinion
Further Information Favourable Opinion