RECRUITING Phase 1 ClinicalTrials.gov

Thermotherapy for Head and Neck Cancer Patients

Sponsor: Erasmus Medical Center • ClinicalTrials.gov ID: NCT07690618

Registry updated: 2026-09-02

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Thermotherapy (Other)
Patients will receive thermotherapy once weekly, adjuvant to standard of care (chemo)radiotherapy.
Radiotherapy (Radiation)
Standard of care radiotherapy, often 70 Gy in 35 daily fractions, 5 times per week.
Concurrent chemoradiation (Radiation)
Standard of care chemoradiotherapy, 70 Gy in 35 daily fractions, 5 times per week with concurrent platinum based chemotherapy (cisplatin or carboplatin).

Eligibility criteria

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.

Conditions

Head and Neck Cancer Oropharyngeal Carcinoma Hypopharyngeal Carcinoma Laryngeal Carcinoma Head and Neck Squamous Cell Carcinoma Oral Cavity Carcinoma Locally Advanced Head and Neck Carcinoma

Locations

Erasmus Medical Center — Rotterdam, South Holland, Netherlands

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment