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. 2021 Nov 5;21(1):1180.
doi: 10.1186/s12885-021-08878-2.

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

Antoine Italiano  1 , Derek Dinart  2   3 , Isabelle Soubeyran  4 , Carine Bellera  5   6 , Hélène Espérou  7 , Christelle Delmas  7 , Noémie Mercier  8 , Sabrina Albert  5   6 , Ludivine Poignie  6 , Anne Boland  9 , Aurélien Bourdon  10   11 , Damien Geneste  10   11 , Quentin Cavaille  10   11 , Yec'han Laizet  10   11 , Emmanuel Khalifa  4 , Céline Auzanneau  4 , Barbara Squiban  4 , Nathalène Truffaux  4 , Robert Olaso  9 , Zuzana Gerber  9 , Cédrick Wallet  5   12 , Antoine Bénard  5   12 , Jean-Yves Blay  13 , Pierre Laurent-Puig  14 , Jean-François Deleuze  9 , Carlo Lucchesi  10   11 , Simone Mathoulin-Pelissier  5   6 ; MULTISARC study group
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Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial

Antoine Italiano et al. BMC Cancer. .

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: clinicaltrial.gov NCT03784014 .

Keywords: Biomarker-driven; Next generation sequencing; Soft-tissue sarcomas; Umbrella.

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Conflict of interest statement

The authors have declared no conflicts of interest.

Figures

Fig. 1
Fig. 1
MULTISARC study design. STS: Soft-tissue Sarcoma; CT: Chemotherapy; RRePS: Pathological referral network for soft tissue and visceral sarcomas; ICF: Informed Consent Form; MTB: Molecular tumour board
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

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