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Clinical Trial Protocol Journal Article Epublish 17 citations

PubMed: 34740331 DOI: 10.1186/s12885-021-08878-2

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

BMC Cancer 21(1):1180

Authors: Antoine Italiano, Derek Dinart, Isabelle Soubeyran, Carine Bellera, Hélène Espérou, Christelle Delmas, Noémie Mercier, Sabrina Albert, Ludivine Poignie, Anne Boland, Aurélien Bourdon, Damien Geneste, Quentin Cavaille, Yec'han Laizet, Emmanuel Khalifa, Céline Auzanneau, Barbara Squiban, Nathalène Truffaux, Robert Olaso, Zuzana Gerber, Cédrick Wallet, Antoine Bénard, Jean-Yves Blay, Pierre Laurent-Puig, Jean-François Deleuze, Carlo Lucchesi, Simone Mathoulin-Pelissier

Affiliations

  • Department of Medical Oncology, Institut Bergonié, University of Bordeaux, INSERM, Unité ACTION U1218, Bordeaux, France.
  • University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.
  • Unité de pathologie moléculaire, Institut Bergonié, Bordeaux, France.
  • Department of Biopathology, Institut Bergonié, U1218, Bordeaux, France.
  • University of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.
  • Clinical Research and Clinical Epidemiology Unit, Institut Bergonié, Bordeaux, France.
  • Inserm, Pôle de Recherche Clinique, 75013, Paris, France.
  • ANRS (France Recherche Nord&sud Sida-hiv Hépatites), Clinical Trial Safety and Public Health, Paris, France.
  • Université Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.
  • U1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.
  • Bioinformatics unit, Institut Bergonié, Bordeaux, France.
  • CHU, Bordeaux, France.
  • Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
  • Sorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.

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 .

MeSH

Sarcoma, Therapeutics, Neoplasms, Tissues, Exome, High-Throughput Nucleotide Sequencing

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