NCT06761937 Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients
| NCT ID | NCT06761937 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Erasmus Medical Center |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-05-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients previously treated by radiation on the same target volume. * Any condition or circumstance potentially hampering compliance with the follow-up schedule. * 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.
Contact & Investigator
Michiel Kroesen, MD, Dr.
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06761937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06761937 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06761937 currently recruiting?
Yes, NCT06761937 is actively recruiting participants. Contact the research team at m.kroesen@erasmusmc.nl for enrollment information.
Where is the NCT06761937 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06761937 clinical trial?
NCT06761937 is sponsored by Erasmus Medical Center. The principal investigator is Michiel Kroesen, MD, Dr. at Erasmus Medical Center. The trial plans to enroll 30 participants.
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