Actively Recruiting
Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients
Led by Erasmus Medical Center · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
S
Sensius BV
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- WHO performance status 0-1
- Mouth opening before treatment of at least 40 mm for women and 45 mm for men
- Confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
- Locally advanced disease, stage III or IV
- Planned curative radiotherapy in the primary setting with contraindication for systemic adjuvant treatment
- Ability to understand study requirements and provide written informed consent
- Written informed consent provided
You will not qualify if you...
- Previous radiation treatment on the same target volume
- Any condition that may interfere with compliance to follow-up schedule
- Presence of pacemakers or clustered metal markers longer than 2 cm in direct contact
- Tumor located below a tracheostomy preventing microwave penetration
- Anatomical limitations of shoulders preventing applicator positioning
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CD
Actively Recruiting
Research Team
M
Michiel Kroesen, MD, Dr.
CONTACT
T
Tessa Coenraad, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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