NCT07690618RecruitingPhase 1
Thermotherapy for Head and Neck Cancer Patients
Thermotherapy for Locally Advanced Head and Neck Cancer Patients in Primary Setting - a Phase I Dose-finding Study
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- Sept 2026
- Primary completion date
- Aug 2028
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Head and neck cancer
- NCT number
- NCT07690618
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From Sept 2026 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated by radiation on the same target volume.
Other illness
- Any condition or circumstance potentially hampering compliance with the follow-up schedule.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.