Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients

Prior treatment

• Previous treatment with trabectedin,
• Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,
• Previous enrolment in the present study.

Other illness

• Known hypersensitivity to any of its components,
• Patients with an active serious or uncontrolled infection upon investigator judgement,
• Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
• 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,
• Abnormal coagulation contraindicating biopsy,
• Any medical and/or biological contra-indication to treatment by trabectedin as per market authorization specification (as per investigator judgement),
• Patients unable to receive corticotherapy,
• Individuals deprived of liberty or placed under guardianship,
• Pregnant or breast feeding women,

• Age ≥ 18 years,
• Histology: undifferentiated pleomorphic sarcomas, epithelioid sarcomas, solitary fibrous tumors, hemangioendothelioma, desmoplastic round cell tumors, synovial sarcomas or other non-leiomyosarcoma/non-liposarcoma softtissue sarcoma. As per the Frech NCI recommendation, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de Référence en Pathologie des Sarcomes des tissus mous et des Viscères),
• Locally advanced/unresectable and/or metastatic disease,
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 1),
• Measurable disease according to RECIST v1.1,
• Indication of trabectedin according to market authorization,
• At least one target lesion that can be biopsied for research,
• Women of childbearing potential must have a negative serum pregnancy test before study entry,
• Patient with a social security in compliance with the French law,
• Voluntary signed and dated written informed consent prior to any study specific procedure,
• Women must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of trabectedin. Men must agree to use a medically acceptable method of contraception throughout the treatment period and for 5 months after discontinuation of trabectedin. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>=1 year.