Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus RAdiotherapy in Soft Tissue Sarcoma patients

This clinical study is promoted by the non-profit organization GEIS (Spanish Sarcoma Research Group) in collaboration with the Italian Sarcoma Group I.S.G. ETS (Italian Group for the Study of Sarcomas) and is multicenter, meaning that several hospitals and treatment centers in Italy and/or abroad are involved. The study aims to evaluate how long patients with soft tissue sarcoma, treated with trabectedin (a drug that binds to DNA and blocks the growth of cancer cells) and radiation therapy, remain free from disease progression. The study also aims to assess the tolerability of the combination of trabectedin and radiation therapy. This combination aims to enhance the effects of both trabectedin and radiation therapy in soft tissue sarcoma with the goal of facilitating surgical intervention. The study features a phase with different cohorts (phase II) classified by tumor type: high-grade leiomyosarcoma (G2-3), liposarcoma (G3 and G2 if at least 30% of the tumor is dedifferentiated according to radiological study), pleomorphic liposarcoma, well-differentiated liposarcoma with cellular variant (WD liposarcoma G1), and dedifferentiated liposarcoma G2 (with less than 30% dedifferentiated component). Currently, the only cohort (referred to as "D") open for enrollment in the study pertains to well-differentiated liposarcoma with a cellular variant (WD liposarcoma G1) and dedifferentiated liposarcoma G2 (with less than 30% dedifferentiated component). Tumors must not have received prior treatment, except for those in cohort D, for which a prior treatment line may have occurred.