Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients

NCT06761937 | Recruiting Phase 1 DMC

• 1 other identifier: NL84322.078.24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Oropharyngeal Carcinoma; Hypopharyngeal Carcinoma; Laryngeal Cancer; Head and Neck Squamous Cell Carcinoma

Keywords

Hyperthermia; Thermotherapy; Clinical Trial; Thermoradiotherapy; Phase 1 trial; Radiosensitization

Outcome Measures

Primary Outcomes (2)

• 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

  8 months (treatment period + follow-up period)

• 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.

  7 weeks (treatment period)

Study Arms (1)

Thermoradiotherapy

EXPERIMENTAL

This arm will receive thermotherapy once a week in addition to the standard radiotherapy.

Procedure: Thermotherapy; Radiation: standard radiotherapy

Interventions

Thermotherapy PROCEDURE

Thermotherapy will be given once a week after a radiotherapy fraction

Also known as: Hyperthermia, thermoradiotherapy

Thermoradiotherapy

standard radiotherapy RADIATION

standard radiotherapy

Thermoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Sensius BV: collaborator
• Amsterdam University Medical Center: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 CD, Netherlands

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Hyperthermia

Interventions

Hyperthermia, Induced; Diathermy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Michiel Kroesen, MD, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michiel Kroesen, MD, Dr.

CONTACT

+31107041116; m.kroesen@erasmusmc.nl

Tessa Coenraad, MSc

CONTACT

+31107041116; t.coenraad@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: January 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)