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MULTISARC : MOLECULAR PROFILING OF ADVANCED SOFT-TISSUE SARCOMAS. A phase III study
EU CTIS ID: 2024-514873-22-00
What this study is testing
In participants with advanced Soft-Tissue Sarcomas: to assess the feasibility of high throughput molecular analysis (next generation sequencing exome [NGS]). Primary objective will be assessed in participants randomized in the arm “NGS”. Feasibility will be defined as the proportion of participants for whom results from NGS are (i) interpretable and (ii) for whom a validated report of exome sequencing including a clinical recommendation from the molecular tumor board is available within 7 weeks (i.e. at most 49 calendar days) after reception of blood and tumor samples by one of the molecular platform.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Eligible to first-line systemic treatment
- No prior or concurrent malignant disease diagnosed or treated in the last two years before inclusion. Note that patients with in situ carcinoma of the cervix, or adequately treated basal cell or squamous cell carcinoma of the skin, or adequately treated localized prostate cancer, or other localized cancer under maintenance therapy can be included as long as they don't limit assessment of efficacy of first-line systemic therapy.
- Participant with a social security in compliance with the French law.
- Voluntary signed and dated written informed consent prior to any study specific procedure (ICF1).
- Histology: soft-tissue sarcoma confirmed by the RRePS Network, as recommended by the French NCI
You likely can't join if
- Radiological evidence of symptomatic or progressive brain metastases.
- Previous enrolment in the present study.
- Any contraindication to first-line systemic treatment.
- Inability to swallow.
- Major problem with intestinal absorption.
- Previous allogeneic bone marrow transplant.
See the full eligibility criteria
- Age ≥ 18 years
- Eligible to first-line systemic treatment
- No prior or concurrent malignant disease diagnosed or treated in the last two years before inclusion. Note that patients with in situ carcinoma of the cervix, or adequately treated basal cell or squamous cell carcinoma of the skin, or adequately treated localized prostate cancer, or other localized cancer under maintenance therapy can be included as long as they don't limit assessment of efficacy of first-line systemic therapy.
- Participant with a social security in compliance with the French law.
- Voluntary signed and dated written informed consent prior to any study specific procedure (ICF1).
- Histology: soft-tissue sarcoma confirmed by the RRePS Network, as recommended by the French NCI
- Unresectable locally advanced and/or metastatic STS
- No previous systemic treatment for advanced disease
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Adequate hematological and metabolic functions: 1. Hemoglobin > 9 g/dL, 2. Albumin > 30 g/L.
- Measurable disease according to RECIST 1.1. At least one site of disease must be uni-dimensionally > 10 mm.
- Availability of suitable frozen archive tumor material from a metastatic lesion or advanced disease (not previously treated), or at least one lesion that can be biopsied for research purpose.
- Archived FFPE block of specimen tumor sampling obtained anytime during disease development for research purpose.
- Radiological evidence of symptomatic or progressive brain metastases.
- Previous enrolment in the present study.
- Any contraindication to first-line systemic treatment.
- Inability to swallow.
- Major problem with intestinal absorption.
- Previous allogeneic bone marrow transplant.
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV or active autoimmune disease).
- Any condition which in the Investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
- ndividuals deprived of liberty or placed under guardianship.
- Pregnant or breast feeding women.
- Men or women refusing contraception.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.