MULTISARC : MOLECULAR PROFILING OF ADVANCED SOFT-TISSUE SARCOMAS. A phase III study

Prior treatment

• Previous enrolment in the present study.
• Previous allogeneic bone marrow transplant.

Other illness

• 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.

Other

• Radiological evidence of symptomatic or progressive brain metastases.
• Any contraindication to first-line systemic treatment.
• Inability to swallow.
• Major problem with intestinal absorption.
• ndividuals deprived of liberty or placed under guardianship.
• Pregnant or breast feeding women.
• Men or women refusing contraception.

• 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.