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Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial

Abstract : Background: Soft-tissue sarcomas (STS) represent a heterogeneous group of rare tumors including more than 70 different histological subtypes. High throughput molecular analysis (next generation sequencing exome [NGS]) is a unique opportunity to identify driver mutations that can change the usual one-size-fits-all treatment paradigm to a patient-driven therapeutic strategy. The primary objective of the MULTISARC trial is to assess whether NGS can be conducted for a large proportion of metastatic STS participants within a reasonable time, and, secondarily to determine whether a NGS-guided therapeutic strategy improves participant's outcome. Methods: This is a randomized, multicentre, phase II/III trial inspired by the design of umbrella and biomarker-driven trials. The setting plans up to 17 investigational centres across France and the recruitment of 960 participants. Participants aged at least 18 years, with unresectable locally advanced and/or metastatic STS confirmed by the French sarcoma pathological reference network, are randomized according to 1:1 allocation ratio between the experimental arm "NGS" and the standard "No NGS". NGS will be considered feasible if (i) NGS results are available and interpretable, and (ii) a report of exome sequencing including a clinical recommendation from a multidisciplinary tumor board is provided to investigators within 7 weeks from reception of the samples on the biopathological platform. A feasibility rate of more than 70% is expected (null hypothesis: 70% versus alternative hypothesis: 80%). In terms of care, participants randomized in "No NGS" arm and who fail treatment will be able to switch to the NGS arm at the request of the investigator. Discussion: The MULTISARC trial is a prospective study designed to provide high-level evidence to support the implementation of NGS in routine clinical practice for advanced STS participants, on a large scale. Trial registration: NCT03784014.
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Submitted on : Thursday, December 9, 2021 - 3:56:42 PM
Last modification on : Tuesday, December 21, 2021 - 2:50:06 PM


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Antoine Italiano, Derek Dinart, Isabelle Soubeyran, Carine Bellera, Hélène Espérou, et al.. Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial. BMC Cancer, BioMed Central, 2021, 21 (1), pp.1180. ⟨10.1186/s12885-021-08878-2⟩. ⟨inserm-03472913⟩



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