drugset / Trial / NCT06835049

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

NCT06835049

Phase 2 Recruiting 24 enrolled Swiss Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-10-27
Primary completion
2028-03-31
Completion
2031-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dacarbazine Small molecule 300 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Subject Ifosfamide Small molecule 3 g Intravenous

Indications