Thermotherapy for Head and Neck Cancer Patients
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia pozwalający na leczenie (WHO 0-1)
- •Możliwość otwarcia ust na co najmniej 40 mm (kobiety) lub 45 mm (mężczyźni)
- •Potwierdzony histologicznie rak płaskorządkowy jamy ustnej, gardła, krtani lub dołu gardła
- •Zaawansowana choroba (stadium III-IV)
- •Planowanie leczenia chemioradioterapią lub samą radioterapią w celu wyleczenia
- •Zdolność do zrozumienia wymagań badania i podpisania zgody
✗ Disqualifies
- •Poprzednie napromienianie w tym samym obszarze
- •Jakikolwiek warunek mogący utrudnić uczestnictwo w badaniu i kontrolę lekarską
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Erasmus Medical Center
Rotterdam, Netherlands
Trial contact
Michiel Kroesen, MD, Dr.
Tessa L. Coenraad, MSc
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/2/2026.
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