Thermotherapy for Head and Neck Cancer Patients

Sponsor
Erasmus Medical Center
Study ID
NCT07690618
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Nov 30, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Thermotherapy adjuvant to chemoradiotherapy
    This primary cohort will consist of patients recieving thermotherapy adjuvant to standard chemoradiotherapy for LAHNC. Dose-escalation is performed in this cohort.
  • Experimental: Thermotherpy adjuvant to radiotherapy monotherapy
    This parallel cohort will consist of patients recieving thermotherapy adjuvant to standard radiotherapy monotherapy for LAHNC. Prospective registration of safety and tolerability is performed in this cohort.

Primary Outcome Measure

Dose Limiting Toxicity: mild trismus [ Time Frame: 8 months (treatment period + follow-up) ]

Central Contacts

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