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TANCA-I
Sponsor study identifier
Secondary identifiers
REGISTRY · ToetsingOnline (CCMO)
interventional
2
1 country
1
Study Start
May 1, 2025
Actual (reported)Primary Completion
June 19, 2026
Actual (reported)Study Completion
August 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Patients with head and neck cancer treated with radiotherapy (RT) have a substantial change of recurrence of the tumor in the pharynx or lymph nodes in the neck. Once tumor and/or lymph nodes have recurred, the prognosis is poor. To increase the efficacy of RT, usually chemotherapy is added to the treatment. However, due to age or co-morbidity chemotherapy is not always feasible to give in all patients. In head and neck patients unfit for chemotherapy, there is a clinical need to increase the effectiveness of RT, without adding substantial toxicity. To this end, the use of thermotherapy in this disease site is investigated. The goal of this clinical trial is to learn about the recommended dose of thermotherapy in addition to radiotherapy for patients with head and neck cancer. This recommended dose is the dose that is tolerable and does not give additional side effects. The main question our study aims to answer is: "What is the recommended dose of thermotherapy for patients with primary head and neck cancer treated with radiotherapy?" Participants will receive thermotherapy once a week in addition to the standard radiotherapy. Researchers will investigate if side effects occur during the treatment and until 6 months after the last treatment has been given. The thermotherapy will be applied using a device that was made in Erasmus MC and allows for precise heating of the tumor and lymph nodes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 20, 2028
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.
December 2, 2024
Actual (reported)January 7, 2025
Actual (reported)May 1, 2025
Actual (reported)June 19, 2026
Actual (reported)August 20, 2028
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 28%.
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 arm will consist of patients recieving thermotherapy adjuvant to standard radiotherapy monotherapy for LAHNC.
Patients will receive thermotherapy once weekly, adjuvant to standard of care radiotherapy.
Standard of care radiotherapy, often 35 daily fractions, 5 times per week.
Erasmus MC
Rotterdam, South Holland, 3015 CD, Netherlands
Michiel Kroesen, MD, Dr.
Erasmus Medical Center
2 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2024
First Posted
January 7, 2025
Study Start
May 1, 2025
Actual (reported)Tolerability of Thermotherapy dose
Tolerability of the thermotherapy dose is defined as the ability of ≥66% of the patients to successfully complete ≥70% 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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 19, 2026
Actual (reported)Study Completion
August 20, 2028
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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