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.
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.
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).
Single group
Thermotherapy
Procedure/SurgeryThermotherapy will be given once a week after a radiotherapy fraction
standard radiotherapy
Radiationstandard radiotherapy
Dose Limiting Toxicity of Thermotherapy
Trismus is objectively scored by measuring the mouth opening using a caliper according to standardized protocol. When the mouth opening is \<35 mm, the patient is scored with trismus and this will be a dose limiting toxicity (DLT). Using a Time to Event Bayesian Optimal Interval Design, we will measure any significant increase over the baseline 28% occurence of trismus with Radiotherapy alone. Upon occurence of the following severe DLTs, the dose level will be stopped immediately: * Grade III trismus * Grade IV mucositis * Grade IV dermatitis * Grade III or IV osteo- or soft tissue necrosis * Grade IV Burn wound * Grade IV tumor hemorrhage * Grade IV laryngeal edema
Feasibility of Thermotherapy
To find the recommended dose, the feasibility of increasing dose levels is investigated. A dose level is infeasible if for \>33% of the patients the intended dose is considered intolerable and is eliminated.
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Erasmus Medical Center
Lead sponsor
Sensius BV
Collaborator
Amsterdam University Medical Center
Collaborator
