Frontline and Relapsed Rhabdomyosarcoma (FAR-RMS) Clinical Trial: A Report from the European Paediatric Soft Tissue Sarcoma Study Group (EpSSG)

Julia Chisholm*, Henry Mandeville, Madeleine Adams, Veronique Minard-Collin, Timothy Rogers, Anna Kelsey, Janet Shipley, Rick R. van Rijn, Isabelle de Vries, Roelof van Ewijk, Bart de Keizer, Susanne A. Gatz, Michela Casanova, Lisa Lyngsie Hjalgrim, Charlotte Firth, Keith Wheatley, Pamela Kearns, Wenyu Liu, Amanda Kirkham, Helen ReesGianni Bisogno, Ajla Wasti, Sara Wakeling, Delphine Heenen, Deborah A. Tweddle, Johannes H. M. Merks, Meriel Jenney, Dominique Heymann (Editor)

*Corresponding author for this work

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Abstract

Simple Summary: This article summarises the international Frontline and Relapsed Rhabdomyosarcoma (FaR-RMS) clinical trial for patients with rhabdomyosarcoma. The trial has multiple research questions relating to chemotherapy and radiotherapy and biological and imaging studies as well as to the introduction of novel drugs for patients with very high-risk disease. The rationale, background, and international collaboration of the trial are explained, and how the data will be used to inform future studies is outlined. Abstract: The Frontline and Relapsed Rhabdomyosarcoma (FaR-RMS) clinical trial is an overarching, multinational study for children and adults with rhabdomyosarcoma (RMS). The trial, developed by the European Soft Tissue Sarcoma Study Group (EpSSG), incorporates multiple different research questions within a multistage design with a focus on (i) novel regimens for poor prognostic subgroups, (ii) optimal duration of maintenance chemotherapy, and (iii) optimal use of radiotherapy for local control and widespread metastatic disease. Additional sub-studies focusing on biological risk stratification, use of imaging modalities, including [18F]FDG PET-CT and diffusion-weighted MRI imaging (DWI) as prognostic markers, and impact of therapy on quality of life are described. This paper forms part of a Special Issue on rhabdomyosarcoma and outlines the study background, rationale for randomisations and sub-studies, design, and plans for utilisation and dissemination of results.
Original languageEnglish
Article number998
Number of pages23
JournalCancers
Volume16
Issue number5
Early online date29 Feb 2024
DOIs
Publication statusE-pub ahead of print - 29 Feb 2024

Bibliographical note

Funding
This study is funded by Cancer Research UK, grant number CRUK/17/011. The regorafenib arm of the FaR-RMS relapse study is funded by the pharmaceutical company Bayer. The Bayer specific code is 17529. The biological studies have been funded by Alice’s Arc Charity.

Keywords

  • radiotherapy
  • clinical trial
  • FaR-RMS
  • EpSSG
  • novel agents
  • randomisation
  • chemotherapy
  • rhabdomyosarcoma

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