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TANCAP-I
Thermotherapy for Locally Advanced Head and Neck Cancer Patients in Primary Setting - a Phase I Dose-finding Study
Sponsor study identifier
interventional
30
1 country
1
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2026
Actual (reported)July 8, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Dose Limiting Toxicity: mild trismus
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.
8 months (treatment period + follow-up)
Dose Limiting Toxicities
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
8 months (treatment period + follow-up)
This primary cohort will consist of patients recieving thermotherapy adjuvant to standard chemoradiotherapy for locally advanced head and neck cancer. Dose-escalation is performed in this cohort.
This parallel cohort will consist of patients recieving thermotherapy adjuvant to standard radiotherapy monotherapy for locally advanced head and neck cancer. Prospective registration of safety and tolerability is performed in this cohort.
Patients will receive thermotherapy once weekly, adjuvant to standard of care (chemo)radiotherapy.
Erasmus Medical Center
Rotterdam, South Holland, 3015 CD, Netherlands
Michiel Kroesen, MD, Dr.
Erasmus Medical Center
First Submitted
July 1, 2026
First Posted
July 8, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Tolerability of thermotherapy dose
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.
7 weeks (treatment period)
Standard of care radiotherapy, often 70 Gy in 35 daily fractions, 5 times per week.
Standard of care chemoradiotherapy, 70 Gy in 35 daily fractions, 5 times per week with concurrent platinum based chemotherapy (cisplatin or carboplatin).
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Primary Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 2, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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