Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC)
Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study
Sponsor: Commissariat A L'energie Atomique
This observational or N/A phase trial investigates Soft Tissue Sarcoma and is currently completed. Commissariat A L'energie Atomique leads this study, which shows 15 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)Screening phase: frozen tumor sample (archived or newly obtained) and blood sample will be used for genetic profiling. Patients can be considered as pre-eligible for the randomized phase when all genetic material have been received by the Platform.
Randomization phase: the randomization will allocate the following arms with a ratio 1:1:
* experimental Arm NGS : treatment strategy based on NGS results \[exome, RNASeq\]
* standard Arm No NGS: treatment strategy not based on NGS (Note that for these participants and under specific conditions, subsequent NGS analyses may be allowed within the scope of the trial)
Single-arm phase II sub-trial: at the end of the first-line treatment and regardless of tumor response as per RECIST v1.1, patients randomized in Arm NGS and for whom a targetable alteration has been identified by the Molecular Tumor Board will be considered as pre-eligible for the targeted sub-study. The mandatory post-chemotherapy wash-out period of 21 days will provide time to achieve all the required tests and examinations.
Screening phase: frozen tumor sample (archived or newly obtained) and blood sample will be used for genetic profiling. Patients can be considered as pre-eligible for the randomized phase when all genetic material have been received by the Platform.
Randomization phase: the randomization will allocate the following arms with a ratio 1:1:
* experimental Arm NGS : treatment strategy based on NGS results \[exome, RNASeq\] * standard Arm No NGS: treatment strategy not based on NGS (Note that for these participants and under specific conditions, subsequent NGS analyses may be allowed within the scope of the trial)
Single-arm phase II sub-trial: at the end of the first-line treatment and regardless of tumor response as per RECIST v1.1, patients randomized in Arm NGS and for whom a targetable alteration has been identified by the Molecular Tumor Board will be considered as pre-eligible for the targeted sub-study. The mandatory post-chemotherapy wash-out period of 21 days will provide time to achieve all the required tests and examinations.
Status Flow
Change History
15 versions recorded-
May 4, 2026 — Present [daily]
Completed
Status: Active Not Recruiting → Completed · Phase: PHASE3 → None
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Jan 2026 — May 2026 [monthly]
Active Not Recruiting PHASE3
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Feb 2025 — Jan 2026 [monthly]
Active Not Recruiting PHASE3
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Sep 2024 — Feb 2025 [monthly]
Active Not Recruiting PHASE3
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE3
▶ Show 10 earlier versions
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May 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE3
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Apr 2024 — May 2024 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Nov 2022 — Apr 2024 [monthly]
Recruiting PHASE3
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Oct 2021 — Nov 2022 [monthly]
Recruiting PHASE3
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Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE3
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Sep 2020 — Jan 2021 [monthly]
Recruiting PHASE3
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Jul 2020 — Sep 2020 [monthly]
Recruiting PHASE3
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Dec 2019 — Jul 2020 [monthly]
Recruiting PHASE3
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Nov 2019 — Dec 2019 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Jan 2019 — Nov 2019 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can be conducted for a large proportion of patients, with results available within reasonnable delays. In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided by high throughput molecular analysis (next generation sequencing exome, RNASeq \[NGS\]) in patients with Advanced/metastatic soft-tissue sarcomas. At the end of first-line treatment, participant's tumor profile of experimental Arm NGS (treatment strategy based on NGS results) will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. Participants for whom a targetable genomic alteration has been identified will be proposed to enter in one of the subsequent phase II single-arm sub-trial.
Contact Information
- Commissariat A L'energie Atomique
- EUCLID Clinical Trial Platform
- Institut Bergonié
- Institut National de la Santé Et de la Recherche Médicale, France
- Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris
- Plateforme labellisée Inca - Institut Bergonié, Bordeaux
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Bordeaux, France , Dijon, France , Lille, France , Lyon, France , Marseille, France , Montpellier, France , Nice, France , Paris, France , Paris, France , Paris, France and 7 more locations