Thermotherapy for Head and Neck Cancer Patients (NCT07690618) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Thermotherapy for Head and Neck Cancer Patients
Netherlands30 participantsStarted 2026-08-01
Plain-language summary
This phase I, single-center study evaluates the safety, tolerability, and recommended phase II dose (RP2D) of mild hyperthermia (thermotherapy) when added to standard-of-care treatment in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC). Tumor recurrence remains common despite chemoradiotherapy, highlighting the need for treatment intensification. Thermotherapy, which increases tumor temperature to 39-45°C, may enhance the effect of the treatment.
The study consists of two components: (1) a dose-escalation cohort in patients receiving definitive chemoradiotherapy, using a Time-to-Event Bayesian Optimal Interval (TiTE-BOIN) design to determine the RP2D based on dose-limiting toxicities (DLTs) and treatment tolerability; and (2) a parallel cohort of patients receiving radiotherapy alone, in whom thermotherapy is administered at dose levels previously shown to be safe and tolerable in the chemoradiotherapy cohort to evaluate tolerability in this patient population.
Besides the safety and tolerability of the thermotherapy RP2D, the secondary objectives include evaluation of safety in patients receiving radiotherapy alone, as well as exploratory assessment of tumor control and survival outcomes.
This study aims to support the development of safe and feasible thermotherapy-based treatment strategies to improve locoregional control and outcomes in patients with LAHNSCC.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicity: mild trismus
Timeframe: 8 months (treatment period + follow-up)
2
Dose Limiting Toxicities
Timeframe: 8 months (treatment period + follow-up)