Molecular Profiling of Advanced Soft-tissue Sarcomas — MULTISARC  

Soft Tissue Sarcoma Clinical Trial

Official title: Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

• NCT number: NCT03784014
• Study type: Interventional
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 19, 2019
• Completion date: October 2025