Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients
Recruiting
Phase 1Interventional Study
Head and Neck CancerOropharyngeal CarcinomaHypopharyngeal CarcinomaLaryngeal CancerHead and Neck Squamous Cell Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Erasmus Medical Center · Other
Who this trial is looking for
This trial is looking for adults with advanced head and neck cancer who cannot receive chemotherapy. Participants will receive a new type of heat treatment along with their regular radiation therapy to see if it helps without causing extra side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced head and neck cancer.
I cannot receive chemotherapy.
I can open my mouth at least 40 mm (women) or 45 mm (men).
I can understand the study requirements and give consent.
I have a confirmed diagnosis of squamous cell carcinoma.
I am able to provide written consent.
You may not be able to join if
I have had radiation treatment on the same area before.
I have a pacemaker or large metal markers in my body.
I have a tracheostomy affecting the tumor location.
I cannot position myself properly for the treatment.
I cannot follow the follow-up schedule.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 pat…
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.
Trial Locations
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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 inten…
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.
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