Head and Neck CancerOropharyngeal CarcinomaHypopharyngeal CarcinomaLaryngeal CarcinomaHead and Neck Squamous Cell CarcinomaOral Cavity CarcinomaLocally Advanced Head and Neck Carcinoma
Thermotherapy: Patients will receive thermotherapy once weekly, adjuvant to standard of care (chemo)radiotherapy.
Radiotherapy: Standard of care radiotherapy, often 70 Gy in 35 daily fractions, 5 times per week.
Concurrent chemoradiation: Standard of care chemoradiotherapy, 70 Gy in 35 daily fractions, 5 times per week with concurrent platinum based chemotherapy (cisplatin or carboplatin).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose Limiting Toxicity: mild trismus — 8 months (treatment period + follow-up) Trismus is objectively scored by measuring the mouth opening using a caliper according to standardized protocol. When the mouth opening is \<35 mm, the patient is scored with trismus and this will be a dose limiting toxicity (DLT). Using a Time to Event Bayesian Optimal Interval Design, we will determine dose (de)escalation with an incidence threshold of 55% in the primary cohort.
Dose Limiting Toxicities — 8 months (treatment period + follow-up) Upon occurence of the following DLTs, the dose level will be stopped immediately for further inclusion: • Grade III trismus • Grade IV mucositis • Grade IV dermatitis • Grade III or IV osteo- or soft tissue necrosis • Grade IV Burn wound • Grade IV tumor hemorrhage • Grade IV laryngeal edema
Tolerability of thermotherapy dose — 7 weeks (treatment period) Tolerability of the thermotherapy dose is defined as the ability of ≥66% of the patients to successfully complete ≥40% of the planned thermotherapy fractions. If the dose level does not meet these criteria, the dose level is considered intolerable and is eliminated.
Trial sites (1)
Facility
City
Region
Status
Erasmus Medical Center
Rotterdam
South Holland
Recruiting
More Erasmus Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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