Mild heat therapy added to standard treatment for locally advanced head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single-center study to find a safe and tolerable dose of thermotherapy (mild hyperthermia) when used with chemoradiotherapy or radiotherapy alone for locally advanced head and neck squamous cell carcinoma. The trial uses a dose-escalation approach with a Bayesian design to identify the recommended dose based on safety signals. A parallel cohort examines tolerability of thermotherapy when added to radiotherapy alone, using previously identified safe dose levels. Thermotherapy is delivered locally to raise tumor temperature to 39-45°C with the goal of enhancing the effectiveness of standard treatments. The study builds on prior work suggesting potential safety concerns like trismus and seeks to establish a prospective, primary safety framework for future efficacy testing.

Why it matters

Who can join: the full rules

For eligibility to participate in this study in the primary cohort, a patient must meet all following criteria:

* Age ≥ 18 years
* WHO 0-1
* Maximal mouth opening of ≥ 40 mm for women and ≥ 45 mm for men before treatment
* Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx proven by cytology/histology
* Locally advanced disease (stage III-IV)
* Curative intent treatment with radiotherapy and concurrent platinum based chemotherapy in primary setting
* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
* Written informed consent

For the parallel secondary cohort, the same inclusion criteria must be met, except for the standard of care treatment:

* Curative intent treatment with radiotherapy monotherapy in primary setting

Exclusion criteria for either cohort:

* Patients previously treated by radiation on the same target volume.
* Any condition or circumstance potentially hampering compliance with the follow-up schedule.

Where it's running

• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Michiel Kroesen, MD, Dr. — Erasmus Medical Center
• Study coordinator: Michiel Kroesen, MD, Dr.
• Email: m.kroesen@erasmusmc.nl
• Phone: +31107041116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.