Actively Recruiting
Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients - a Phase I Trial
Led by Erasmus Medical Center · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
91 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
Researchers are studying patients with locally advanced head and neck squamous cell carcinoma (HNSCC) who are treated with radiotherapy (RT) but cannot receive chemotherapy due to age or other health issues. The trial aims to find the recommended dose of thermotherapy added to radiotherapy that is tolerable and does not cause extra side effects. Thermotherapy involves heating the tumor area to improve the effectiveness of radiotherapy, especially since chemotherapy may be too toxic for some patients. Participants will receive thermotherapy once a week alongside standard radiotherapy using a device called the HyperCollar3D, which precisely heats tumors and lymph nodes in the head and neck while avoiding sensitive tissues. The dose of thermotherapy will be gradually increased to find the highest safe dose. In some cases, a temperature probe may be placed in a lymph node to measure the heat during treatment, with separate consent. This is a phase I dose-finding study focusing on safety and tolerability. During the approximately 7-week treatment period and up to 6 months after, researchers will monitor side effects, especially trismus (limited mouth opening), and other toxicities. Patients will undergo regular assessments including mouth opening measurements and patient and doctor-reported outcomes. The trial will determine the recommended dose of thermotherapy to combine with radiotherapy for future studies, while also evaluating local tumor control, disease-free survival, and overall survival.
CONDITIONS
Brief Title
Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3e= 18 years
- WHO performance status 0-1
- Mouth opening before treatment of �3e= 40 mm for women and �3e= 45 mm for men
- Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx confirmed by cytology or histology
- Locally advanced disease (stage III-IV)
- Planned curative radiotherapy with contraindication for systemic adjuvant treatment
- Ability to understand study requirements and provide written informed consent
- Written informed consent obtained
You will not qualify if you...
- Previous radiation treatment on the same target volume
- Any condition or circumstance interfering with compliance to follow-up
- Presence of pacemakers or clustered metal markers exceeding 2 cm in contact
- Tumor located below a tracheostomy preventing microwave penetration
- Shoulder anatomy preventing positioning of the thermotherapy applicator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 weeks
Participants receive standard radiotherapy with additional thermotherapy once a week after a radiotherapy fraction to enhance treatment effectiveness.
Weekly visits for up to 7 weeks
Duration - Up to 6 months after treatment
Participants are monitored for dose limiting toxicities, feasibility, and side effects including trismus for up to 6 months after treatment ends.
Regular follow-up visits during 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CD
Actively Recruiting
Research Team
M
Michiel Kroesen, MD, Dr.
T
Tessa Coenraad, MSc
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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