Phase I Study of Thermotherapy with Radiotherapy for Adults with Locally Advanced Head and Neck Cancer

What this Trial Is About

Researchers are studying patients with locally advanced head and neck squamous cell carcinoma HNSCC who are treated with radiotherapy RT but cannot receive chemotherapy due to age or other health issues. The trial aims to find the recommended dose of thermotherapy added to radiotherapy that is tolerable and does not cause extra side effects. Thermotherapy involves heating the tumor area to improve the effectiveness of radiotherapy, especially since chemotherapy may be too toxic for some patients. Participants will receive thermotherapy once a week alongside standard radiotherapy using a device called the HyperCollar3D, which precisely heats tumors and lymph nodes in the head and neck while avoiding sensitive tissues. The dose of thermotherapy will be gradually increased to find the highest safe dose. In some cases, a temperature probe may be placed in a lymph node to measure the heat during treatment, with separate consent. This is a phase I dose-finding study focusing on safety and tolerability. During the approximately 7-week treatment period and up to 6 months after, researchers will monitor side effects, especially trismus limited mouth opening, and other toxicities. Patients will undergo regular assessments including mouth opening measurements and patient and doctor-reported outcomes. The trial will determine the recommended dose of thermotherapy to combine with radiotherapy for future studies, while also evaluating local tumor control, disease-free survival, and overall survival.

Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients