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 u...
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oai:doaj.org-article:a537e8b223744e2f9d8f9b6743f5ae552021-11-08T11:02:19ZMolecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial10.1186/s12885-021-08878-21471-2407https://doaj.org/article/a537e8b223744e2f9d8f9b6743f5ae552021-11-01T00:00:00Zhttps://doi.org/10.1186/s12885-021-08878-2https://doaj.org/toc/1471-2407Abstract 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 .Antoine ItalianoDerek DinartIsabelle SoubeyranCarine BelleraHélène EspérouChristelle DelmasNoémie MercierSabrina AlbertLudivine PoignieAnne BolandAurélien BourdonDamien GenesteQuentin CavailleYec’han LaizetEmmanuel KhalifaCéline AuzanneauBarbara SquibanNathalène TruffauxRobert OlasoZuzana GerberCédrick WalletAntoine BénardJean-Yves BlayPierre Laurent-PuigJean-François DeleuzeCarlo LucchesiSimone Mathoulin-Pelissierthe MULTISARC study groupBMCarticleNext generation sequencingSoft-tissue sarcomasUmbrellaBiomarker-drivenNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBMC Cancer, Vol 21, Iss 1, Pp 1-10 (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Next generation sequencing Soft-tissue sarcomas Umbrella Biomarker-driven Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 |
| spellingShingle |
Next generation sequencing Soft-tissue sarcomas Umbrella Biomarker-driven Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 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 the MULTISARC study group Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial |
| description |
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 . |
| format |
article |
| author |
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 the MULTISARC study group |
| author_facet |
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 the MULTISARC study group |
| author_sort |
Antoine Italiano |
| title |
Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial |
| title_short |
Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial |
| title_full |
Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial |
| title_fullStr |
Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial |
| title_full_unstemmed |
Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial |
| title_sort |
molecular profiling of advanced soft-tissue sarcomas: the multisarc randomized trial |
| publisher |
BMC |
| publishDate |
2021 |
| url |
https://doaj.org/article/a537e8b223744e2f9d8f9b6743f5ae55 |
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