NCT06761937Active, not recruitingPhase 1
Thermotherapy for Locally Advanced Head and Neck Cancer
Thermotherapy for Locally Advanced Head and Neck CAncer Patients - a Phase I Trial.
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- First submitted
- 2 Dec 2024
- Start date
- 1 May 2025
- Primary completion date
- 19 Jun 2026
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06761937
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 2
- From 1 May 2025 to the primary completion date, 19 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated by radiation on the same target volume.
Other illness
- Any condition or circumstance potentially hampering compliance with the follow-up schedule.
Other
- Patients having pacemakers or clustered metal markers (with a total length \>2 cm of metal markers in direct contact).
- Tumor location caudal to a tracheostomy (this prevents penetration of the microwaves to the tumor).
- Anatomical boundaries of the shoulders prohibiting positioning of the applicator.
Who the study is looking for
- Age \>= 18 years
- WHO 0-1
- Mouth opening before treatment of \>= 40 mm for women and \>= 45mm for men
- Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx proven by cytology / histology.
- Locally advanced disease (stage III-IV).
- Curative intend treatment with radiotherapy in the primary setting with a contraindication for systemic adjuvant treatment.
- Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
- Written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.