RecruitingPhase 1NCT06761937

Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients

Thermoradiotherapy for Locally Advanced Head and Neck CAncer Patients - a Phase I Trial.


Sponsor

Erasmus Medical Center

Enrollment

30 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with head and neck cancer treated with radiotherapy (RT) have a substantial change of recurrence of the tumor in the pharynx or lymph nodes in the neck. Once tumor and/or lymph nodes have recurred, the prognosis is poor. To increase the efficacy of RT, usually chemotherapy is added to the treatment. However, due to age or co-morbidity chemotherapy is not always feasible to give in all patients. In head and neck patients unfit for chemotherapy, there is a clinical need to increase the effectiveness of RT, without adding substantial toxicity. To this end, the use of thermotherapy in this disease site is investigated. The goal of this clinical trial is to learn about the recommended dose of thermotherapy in addition to radiotherapy for patients with head and neck cancer. This recommended dose is the dose that is tolerable and does not give additional side effects. The main question our study aims to answer is: "What is the recommended dose of thermotherapy for patients with primary head and neck cancer treated with radiotherapy?" Participants will receive thermotherapy once a week in addition to the standard radiotherapy. Researchers will investigate if side effects occur during the treatment and until 6 months after the last treatment has been given. The thermotherapy will be applied using a device that was made in Erasmus MC and allows for precise heating of the tumor and lymph nodes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding heat therapy (hyperthermia) to standard radiation treatment improves outcomes for patients with locally advanced head and neck cancer — particularly those who cannot receive the usual chemotherapy given alongside radiation. **You may be eligible if...** - You are 18 or older and in good general health (WHO performance 0–1) - You have squamous cell carcinoma of the mouth, throat (oropharynx/hypopharynx), or voice box (larynx) - Your cancer is locally advanced (stage III–IV) - You are being treated with radiation for curative intent but cannot receive systemic therapy (chemotherapy) - You can open your mouth wide enough for treatment (≥40mm for women, ≥45mm for men) **You may NOT be eligible if...** - You have previously had radiation to the same area - You have a pacemaker or implanted metal devices that interfere with heat treatment - You have conditions that prevent you from completing follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREThermotherapy

Thermotherapy will be given once a week after a radiotherapy fraction

RADIATIONstandard radiotherapy

standard radiotherapy


Locations(1)

Erasmus MC

Rotterdam, South Holland, Netherlands

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NCT06761937


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