Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients

Launched by ERASMUS MEDICAL CENTER · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced head and neck cancers, such as oropharyngeal and laryngeal cancers. The researchers want to find out the best and safest dose of thermotherapy, a type of heat treatment, that can be used alongside standard radiotherapy. The goal is to make the radiotherapy more effective in treating the cancer without causing extra side effects, especially for patients who cannot tolerate chemotherapy due to age or other health issues.

To participate in this study, individuals must be at least 18 years old, have a specific type of advanced squamous cell carcinoma, and be able to open their mouth adequately for treatment. Participants will receive thermotherapy once a week while undergoing radiotherapy, and the team will closely monitor any side effects during treatment and for up to six months afterward. This trial is not yet recruiting participants, but it aims to help improve treatment options for patients who are unable to receive chemotherapy.

Gender

ALL

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.