Study of Combined Chemotherapy, Hyperthermia, Radiotherapy, and Surgery in Adults With High-risk Soft Tissue Sarcoma of the Extremity or Trunk

What this Trial Is About

Researchers are investigating a new combined treatment approach for rare high-risk soft tissue sarcomas STSs located in the extremities and trunk. These cancers have a 5-year survival rate of about 60%, and there is currently no standard treatment for this group. Evidence from earlier studies suggests that adding moderate regional hyperthermia HT to chemotherapy, followed by surgery and radiotherapy RT, may improve long-term survival. This trial aims to optimize treatment by combining the best regimens from chemotherapy, HT, RT, and surgery into a total neoadjuvant treatment TNT plan and will assess how feasible this approach is for patients. The treatment consists of three neoadjuvant cycles of doxorubicin combined with either ifosfamide or dacarbazine used only for leiomyosarcoma, alongside hyperthermia sessions. Each chemotherapy cycle lasts three weeks, with HT sessions on days 1 and 3 of each cycle. After chemotherapy and HT, patients receive radiotherapy, ideally starting about 19 days after the last chemotherapy dose, delivered daily except weekends over several weeks. Surgery to remove tumors is planned about six weeks after completing radiotherapy. Overall, the treatment period lasts about 20 weeks. Participants will be closely monitored throughout the trial, including up to 36 months after surgery. Researchers will assess how well patients tolerate the combined treatment schedule as the primary goal. They will also track disease-free survival, measuring the time until tumor relapse, disease progression, or death up to three years after starting the trial. Assessments include imaging, pathology reviews, and evaluations of organ functions to ensure safety and treatment effectiveness.

Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)