SAKK 57/24 TNT-HYPE

Feasibility Study of a Fully Preoperative Therapy Using Chemotherapy, Hyperthermia, and Radiation in Patients with Soft Tissue Sarcomas of the Extremities or Trunk at High Risk of Recurrence.
Soft tissue sarcomas are a rare type of cancer, accounting for only about 1% of all human cancers. These tumors can vary greatly. If the cancer has not yet spread in the body, treatment typically involves surgical removal of the tumor. Radiation therapy is usually administered before or after surgery. Despite this treatment approach, only about 60% of patients survive the five years following therapy.
Due to the rarity of soft tissue sarcomas, there are few large studies, and no standardized treatment exists for particularly aggressive sarcomas of the limbs and trunk. The goal of the current SAKK 57/24 TNT-HYPE study is to test a new and modern treatment standard in Switzerland for patients with aggressive soft tissue sarcomas, integrating hyperthermia to improve survival chances.

The proposed treatment plan:

The proposed treatment plan consists of several treatment blocks, starting with chemotherapy combined with hyperthermia. The type and dosage of chemotherapy are based on the most commonly used regimen for sarcomas. This chemotherapy is combined with hyperthermia, as a large study has already shown promising results. In hyperthermia treatment, the tumor is externally heated to about 41°C using microwaves—essentially inducing a fever in the tumor area, making cancer cells more sensitive to chemotherapy. The subsequent radiation therapy is added preoperatively, in line with Swiss practices.
The advantage of conducting all treatment blocks before surgery is that chemotherapy and hyperthermia can first target hidden metastases, shrink the tumor, and facilitate surgery. Radiation therapy can then further improve operability and tumor control. However, the downside is that the treatment takes relatively long while the tumor remains in the body.
This is a national study conducted at multiple centers in Switzerland, initially testing the feasibility of the treatment plan. The second objective is to evaluate the effect of therapy on tumor control and tolerability. It is a Phase II study with a single treatment group. A total of 24 patients are to be enrolled over 2.5 years and followed for 3 years.