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Thermotherapy for Head and Neck Cancer Patients (TANCAP-I)

1 september 2026 bijgewerkt door: Michiel Kroesen, Erasmus Medical Center

Thermotherapy for Locally Advanced Head and Neck Cancer Patients in Primary Setting - a Phase I Dose-finding Study

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Locoregionally advanced head and neck cancer (LAHNC) carries a substantial risk of locoregional recurrence despite curative-intent chemoradiotherapy. Most recurrences arise within high-dose radiation regions, suggesting that additional intensification of locoregional therapy may be required. Thermotherapy (mild hyperthermia) is a non-invasive, local regional treatment that can enhance the effect of radiotherapy and chemotherapy by multiple working mechanisms, including improving tissue oxygenation, inhibiting DNA-repair mechanisms, and stimulating immune response. Before thermotherapy can be integrated into curative-intent treatment for LAHNC, its safety and tolerability in combination with (chemo)radiotherapy must be established in a prospective setting.

Previous work at Erasmus MC with the first-generation HyperCollar and the next-generation HyperCollar3D involved patients with recurrent or second-primary HNSCC receiving re-irradiation with thermotherapy. These cohorts suggested a possible dose-dependent relationship between the delivered energy and acute trismus, with fewer events observed after dose reduction. Although these findings were encouraging, the re-irradiation population is not directly representative of patients with primary LAHNC. Consequently, the optimal and safely deliverable thermotherapy dose for primary disease remains unknown, and prospective dose-finding in a chemoradiotherapy setting is needed.

The TANCAP-I trial is a prospective phase I study evaluating the safety, tolerability, and highest safely deliverable thermotherapy dose in LAHNC. The study consists of two single-arm cohorts. The primary cohort includes patients receiving definitive chemoradiotherapy and serves as the dose-escalation cohort. Dose escalation is guided by the Time-to-Event Bayesian Optimal Interval (TITE-BOIN) design, which incorporates the timing of toxicity events and allows for efficient, ethically balanced dose escalation, using mild trismus (mouth opening limited <35 mm) as the guiding DLT. The secondary cohort consists of patients receiving radiotherapy monotherapy for whom chemotherapy is contraindicated. In this group, thermotherapy safety and tolerability will be prospectively recorded without independent dose escalation.

For both groups, thermotherapy will be administered once weekly using the HyperCollar3D device, which enables precise, patient-specific deep heating of the primary tumor and involved lymph nodes. The applied thermotherapy dose is defined by Specific Absorption Rate (W/kg) in 50cc healthy tissues. Optional invasive temperature measurements may be performed in a subset of participants under separate consent.

Safety and tolerability will be assessed at baseline, throughout treatment and up to 6 months following completion. Dose-limiting toxicities (DLTs) include mild trismus and predefined severe grade III-IV toxicities. Tolerability is defined by a participant's ability to complete planned thermotherapy sessions.

Results from the TANCAP-I trial will inform the recommended phase 2 dose (RP2D) and provide the foundation for future studies evaluating whether adjuvant thermotherapy can safely enhance locoregional control and improve outcomes for patients with LAHNC.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Nederland
    • South Holland
      • Rotterdam, South Holland, Nederland, 3015 CD
        • Werving
        • Erasmus Medical Center
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Thermotherapy adjuvant to chemoradiotherapy
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.
Ander: Thermotherapy
Patients will receive thermotherapy once weekly, adjuvant to standard of care (chemo)radiotherapy.
Andere namen:
  • Hyperthermie
Straling: Concurrent chemoradiation
Standard of care chemoradiotherapy, 70 Gy in 35 daily fractions, 5 times per week with concurrent platinum based chemotherapy (cisplatin or carboplatin).
Experimenteel: Thermotherpy adjuvant to radiotherapy monotherapy
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.
Ander: Thermotherapy
Patients will receive thermotherapy once weekly, adjuvant to standard of care (chemo)radiotherapy.
Andere namen:
  • Hyperthermie
Straling: Radiotherapy
Standard of care radiotherapy, often 70 Gy in 35 daily fractions, 5 times per week.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dose Limiting Toxicity: mild trismus
Tijdsspanne: 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.
8 months (treatment period + follow-up)
Dose Limiting Toxicities
Tijdsspanne: 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
8 months (treatment period + follow-up)
Tolerability of thermotherapy dose
Tijdsspanne: 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.
7 weeks (treatment period)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Erasmus Medical Center

Medewerkers

Dutch Cancer Society
Sensius BV

Onderzoekers

  • Hoofdonderzoeker: Michiel Kroesen, MD, Dr., Erasmus Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 augustus 2028

Studie voltooiing (Geschat)

1 november 2031

Studieregistratiedata

Eerst ingediend

1 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juli 2026

Eerst geplaatst (Werkelijk)

8 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NL-011902

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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