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New beam angle may spare cancer patients from dry mouth and swallowing woes

NCT ID NCT07413627

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new way of aiming radiation beams (non-coplanar) can reduce side effects like dry mouth and swallowing problems in people with head and neck cancer. About 70 adults with cancer of the mouth or throat will be randomly assigned to standard or new radiation. The main goal is to see if quality of life improves three months after treatment.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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 * Patient diagnosed with non-operated, non-metastatic squamous cell carcinoma of the oral cavity or oropharynx, histologically confirmed, with p16 status determined by immunohistochemistry, and indicated for curative bilateral radiotherapy, with or without concomitant chemotherapy * Patient scheduled to receive standard photobiomodulation treatment protocol during radiotherapy * ECOG performance status ≤ 2 * Presence of xerostomia \< 1 according to CTCAE v6.0 at pre-inclusion * Patient able to provide informed consent and capable of complying with study follow-up, including visits for completion of quality of life questionnaires and salivary tests * Patient affiliated with a social security system or equivalent Inclusion Criteria (RECOARD 2.0 recommendations) to be confirmed with the information provided by the simulation/plan treatment CT scan : \- Exceedance of a dose constraint for at least one Organ at Risk (OAR) as defined below with a coplanar beam arrangement : * The average dose delivered to at least one parotid gland must be greater than 26 Grays, and/or =\> 65% of the oral cavity receives a dose greater than 30 Grays, and/or * The average dose delivered to at least one submandibular gland must be greater than 32 Grays, and/or * The average dose delivered to the larynx exceeds 43.5 Grays. Exclusion Criteria: * Other head and neck locations than the oral cavity and oropharynx, and/or a surgically treated UADT cancer, and/or radiotherapy treatment already started. * Histologies other than squamous cell carcinoma * Tumors requiring only unilateral irradiation. * Non-curative irradiation and/or metastatic patient * Double tumor localization * Previous history of head and neck radiotherapy. * Inability to comply with study follow-up visits and medical assessments due to geographical, social, or psychological reasons. * Individuals under legal custody or guardianship (including curatorship). * Pregnant or breastfeeding women (pregnancy test required at inclusion).

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Conditions

The condition(s) this trial relates to.

Mouth Neoplasms oral cavity squamous cell carcinoma oropharynx cancer oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck Xerostomia

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Georges-François Leclerc

    Dijon, 21000, France

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Other studies related to the condition(s) this trial covers.