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Can heat make radiation more effective against head and neck cancer?

NCT ID NCT06761937

Disease control Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This trial tests whether adding weekly thermotherapy, a treatment that heats the tumor and lymph nodes, to standard radiotherapy can help people with head and neck cancer who cannot receive chemotherapy. The goal is to find a safe dose of thermotherapy that does not cause severe side effects. Participants will receive the heated treatment once a week alongside their usual radiation schedule. Researchers will monitor for side effects during treatment and for six months after the last session.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Thermotherapy (hyperthermia) added to standard radiotherapy
What this could lead to
If it works, this could offer a way to boost the effectiveness of radiotherapy for head and neck cancer patients who cannot tolerate chemotherapy, potentially reducing the chance of tumor recurrence.
What could go wrong
This is a very early, small phase 1 trial with only 2 participants, so results may not apply broadly. The added heat could cause side effects like burns, tissue damage, or severe mouth or throat inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

2 people

The number who actually took part.

Started

May 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Hyperthermia hypopharyngeal carcinoma hypopharynx cancer laryngeal carcinoma laryngeal neoplasm Mouth Neoplasms oral cavity carcinoma oropharyngeal carcinoma oropharynx cancer Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer Head and neck squamous cell carcinoma Hypopharyngeal carcinoma Laryngeal cancer Oral cavity carcinoma Oropharyngeal carcinoma

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, South Holland, 3015 CD, Netherlands

More trials for these conditions

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