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

Inclusion Criteria

• •1. Age ≥ 18 years,
• •2. 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),
• •3. Locally advanced/unresectable and/or metastatic disease,
• •4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 1),
• •5. Measurable disease according to RECIST v1.1,
• •6. Indication of trabectedin according to market authorization,
• •7. At least one target lesion that can be biopsied for research,
• •8. Women of childbearing potential must have a negative serum pregnancy test before study entry,
• •9. Patient with a social security in compliance with the French law,
• •10. Voluntary signed and dated written informed consent prior to any study specific procedure,
• •11. 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.