Adding focused heat to radiation for advanced head and neck cancer
Thermoradiotherapy for Locally Advanced Head and Neck CAncer Patients - a Phase I Trial.
This will test whether adding focused heat (thermotherapy) to standard radiotherapy is safe and tolerable for adults with advanced head and neck cancer who can't receive chemotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06761937 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial combines localized thermotherapy with standard radiotherapy in patients with stage III–IV head and neck squamous cell carcinoma who are not candidates for systemic chemotherapy. Thermotherapy uses focused heating applied to macroscopic tumor sites during the radiotherapy course, with radiotherapy delivered using a simultaneous integrated boost technique. A dose-escalation approach is used to find the recommended thermotherapy dose that patients can tolerate without adding significant side effects. Safety, tolerability, and acute toxicity are closely monitored to define the recommended dose for future studies.
Who should consider this trial
Good fit: Adults (≥18) with stage III–IV squamous cancers of the oral cavity, oropharynx, hypopharynx, or larynx, WHO 0–1, planned for curative radiotherapy and who have a contraindication to systemic adjuvant treatment are the intended candidates.
Not a fit: Patients previously irradiated to the same target volume, those with pacemakers or problematic metal markers, tumor locations below a tracheostomy, or who can safely receive standard chemoradiation are less likely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control without the added systemic toxicity of chemotherapy, offering a treatment option for patients who cannot tolerate chemo.
How similar studies have performed: Combining hyperthermia with radiotherapy has shown radiosensitizing and local-control benefits in some tumor types, but robust evidence specifically for locally advanced head and neck cancer is limited and this remains an early-phase exploration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Michiel Kroesen, MD, Dr. — Erasmus Medical Center
- Study coordinator: Michiel Kroesen, MD, Dr.
- Email: m.kroesen@erasmusmc.nl
- Phone: +31107041116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.