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

Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.

NCT Number	NCT06835049
Lead Sponsor	Swiss Cancer Institute
Conditions	Sarcoma,Soft Tissue
Enrollment	24 participants
Start Date	2025-10-27
Primary Completion	2028-03-31 (estimated)
Study Completion	2031-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-30