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

dc.rights.licenseopenen_US
dc.contributor.authorITALIANO, Antoine
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDINART, Derek
dc.contributor.authorSOUBEYRAN, Isabelle
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorESPEROU, Helene
dc.contributor.authorDELMAS, Christelle
dc.contributor.authorMERCIER, Noemie
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorALBERT, Sabrina
dc.contributor.authorPOIGNIE, Ludivine
dc.contributor.authorBOLAND, Anne
dc.contributor.authorBOURDON, Aurelien
dc.contributor.authorGENESTE, Damien
dc.contributor.authorCAVAILLE, Quentin
dc.contributor.authorLAIZET, Yec'Han
dc.contributor.authorKHALIFA, Emmanuel
dc.contributor.authorAUZANNEAU, Celine
dc.contributor.authorSQUIBAN, Barbara
dc.contributor.authorTRUFFAUX, Nathalene
dc.contributor.authorOLASO, Robert
dc.contributor.authorGERBER, Zuzana
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorWALLET, Cedrick
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBENARD, Antoine
dc.contributor.authorBLAY, Jean-Yves
dc.contributor.authorLAURENT-PUIG, Pierre
dc.contributor.authorDELEUZE, Jean Francois
dc.contributor.authorLUCCHESI, Carlo
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMATHOULIN-PELISSIER, Simone
dc.date.accessioned2022-06-16T14:33:37Z
dc.date.available2022-06-16T14:33:37Z
dc.date.issued2021-11-05
dc.identifier.issn1471-2407en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/140248
dc.description.abstractEnBackground: 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.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enBiomarker-driven
dc.subject.enNext generation sequencing
dc.subject.enSoft-tissue sarcomas
dc.subject.enUmbrella
dc.title.enMolecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s12885-021-08878-2en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed4740331en_US
bordeaux.journalBMC Canceren_US
bordeaux.page1180en_US
bordeaux.volume21en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.exportfalse
dc.rights.ccCC BYen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=BMC%20Cancer&rft.date=2021-11-05&rft.volume=21&rft.issue=1&rft.spage=1180&rft.epage=1180&rft.eissn=1471-2407&rft.issn=1471-2407&rft.au=ITALIANO,%20Antoine&DINART,%20Derek&SOUBEYRAN,%20Isabelle&BELLERA,%20Carine&ESPEROU,%20Helene&rft.genre=article


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