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Could skipping the flap during radiation reduce side effects without harming cancer control?

NCT ID NCT06798922

Disease control Sponsor: Centre Francois Baclesse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This study tests whether avoiding radiation to the surgical flap (the tissue used to rebuild the mouth after cancer removal) is as effective as standard radiation that treats the whole area. About 348 adults with oral cavity cancer who had reconstructive surgery will be randomly assigned to either flap-sparing or standard radiation. The goal is to see if the gentler approach can maintain cancer control while reducing side effects like mouth and throat problems.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 348 people

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

Started

Mar 2025

Expected to finish

Mar 2034

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: * Patient aged 18 years or older * Performance Status 0-2 * Patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. Oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study * Quality of resection with margins \> 1 mm * Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy) * Concomitant chemotherapy is allowed (stratification parameter) * Patient must have signed a written informed consent form prior to any trial specific procedures * Patient affiliated to the social security system Exclusion Criteria: * Local flap (small size limiting IMRT modulation potential) * History of radiotherapy of head and neck area * Metastatic disease * History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma) * Simultaneous participation in another clinical study may compromise the conduct of this study. * Pregnant or lactating women * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol * Patient deprived of freedom or under guardianship

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Conditions

The condition(s) this trial relates to.

Mouth Neoplasms oral cavity cancer oral cavity carcinoma

As listed by the trial registrant

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

FLAP Oral cavity carcinoma Radiotherapy, adjuvant Reconstruction surgery

How to take part

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

  1. The places running it

    30 sites. 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

  • APHM Marseille

    NOT_YET_RECRUITING

    Marseille, France

  • APHP La Pitié

    NOT_YET_RECRUITING

    Paris, France

  • CHIC

    NOT_YET_RECRUITING

    Créteil, France

  • CHU CAEN

    NOT_YET_RECRUITING

    Caen, France

  • Centre Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, France

  • Centre Eugène Marquis

    NOT_YET_RECRUITING

    Rennes, France

  • Centre François Baclesse

    RECRUITING

    Caen, France

  • Centre Frédéric Joliot

    NOT_YET_RECRUITING

    Rouen, France

  • Centre Georges-François Leclerc

    NOT_YET_RECRUITING

    Dijon, France

  • Centre Guillaume le Conquérant

    NOT_YET_RECRUITING

    Le Havre, France

  • Centre Henri Becquerel

    NOT_YET_RECRUITING

    Rouen, France

  • Centre Hospitalier

    NOT_YET_RECRUITING

    Cherbourg, France

  • Centre Hospitalier

    NOT_YET_RECRUITING

    Libourne, France

  • Centre Jean Perrin

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, France

  • Centre Oscar Lambret

    NOT_YET_RECRUITING

    Lille, France

  • Centre de la Baie

    NOT_YET_RECRUITING

    Avranches, France

  • Chu Amiens

    NOT_YET_RECRUITING

    Amiens, France

  • Chu Limoges

    NOT_YET_RECRUITING

    Limoges, France

  • Chu Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • Chu Reims

    NOT_YET_RECRUITING

    Reims, France

  • Chu Rouen

    NOT_YET_RECRUITING

    Rouen, France

  • Chu Tours

    NOT_YET_RECRUITING

    Tours, France

  • IUCT

    NOT_YET_RECRUITING

    Toulouse, France

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, France

  • Institut Jean Godinot

    NOT_YET_RECRUITING

    Reims, France

  • Institut Régional du Cancer Val D'aurelle

    NOT_YET_RECRUITING

    Montpellier, France

  • Institut de Cancérologie de Lorraine

    NOT_YET_RECRUITING

    Nancy, France

  • Institut de Cancérologie de l'Ouest

    NOT_YET_RECRUITING

    Angers, France

  • Institut de Cancérologie de l'Ouest

    NOT_YET_RECRUITING

    Saint-Herblain, France

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