Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Last updated: March 2, 2026
Sponsor: Centre Francois Baclesse
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Post-operative radiotherapy with flap sparing

Standard post-operative radiotherapy without flap sparing (current practice)

Clinical Study ID

NCT06798922
2024-A01764-43
  • Ages > 18
  • All Genders

Study Summary

Patients with oral cavity cancer treated by reconstructive surgery with a flap.

Patients will be treated in the study for :

  • Experimental arm: Post-operative radiotherapy with flap sparing

  • Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)

Eligibility Criteria

Inclusion

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 byreconstructive surgery with a flap. Oropharynx cancer whose flap extendssignificantly 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 RadiationTherapy (IMRT) or proton therapy)

  • Concomitant chemotherapy is allowed (stratification parameter)

  • Patient must have signed a written informed consent form prior to any trial specificprocedures

  • Patient affiliated to the social security system

Exclusion

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 appropriatelytreated in-situ cervix carcinoma and non-melanoma skin carcinoma)

  • Simultaneous participation in another clinical study may compromise the conduct ofthis study.

  • Pregnant or lactating women

  • Patient assessed by the investigator to be unable or unwilling to comply with therequirements of the protocol

  • Patient deprived of freedom or under guardianship

Study Design

Total Participants: 348
Treatment Group(s): 2
Primary Treatment: Post-operative radiotherapy with flap sparing
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
March 01, 2034

Study Description

Patients with oral cavity cancer treated by reconstructive surgery with a flap.

Patients will be treated in the study for :

  • Experimental arm: Post-operative radiotherapy with flap sparing

  • Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT) Our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.

Connect with a study center

  • Chu Amiens

    Amiens,
    France

    Site Not Available

  • Chu Amiens

    Amiens 3037854,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Angers,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Angers 3037656,
    France

    Site Not Available

  • CHU CAEN

    Caen,
    France

    Site Not Available

  • Centre François Baclesse

    Caen,
    France

    Active - Recruiting

  • CHU CAEN

    Caen 3029241,
    France

    Site Not Available

  • Centre François Baclesse

    Caen 3029241,
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont Ferrand,
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand,
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand 3024635,
    France

    Site Not Available

  • CHIC

    Créteil,
    France

    Site Not Available

  • CHIC

    Créteil 3022530,
    France

    Site Not Available

  • Centre Georges-François Leclerc

    Dijon,
    France

    Site Not Available

  • Centre Georges-François Leclerc

    Dijon 3021372,
    France

    Site Not Available

  • Centre Guillaume le Conquérant

    Le Havre,
    France

    Site Not Available

  • Centre Guillaume le Conquérant

    Le Havre 3003796,
    France

    Site Not Available

  • Centre Hospitalier

    Libourne,
    France

    Site Not Available

  • Centre Hospitalier

    Libourne 2998517,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille 2998324,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon 2996944,
    France

    Site Not Available

  • APHM Marseille

    Marseille,
    France

    Site Not Available

  • APHM Marseille

    Marseille 2995469,
    France

    Site Not Available

  • Institut Régional du Cancer Val D'aurelle

    Montpellier,
    France

    Site Not Available

  • Institut Régional du Cancer Val D'aurelle

    Montpellier 2992166,
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Nancy,
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Nancy 2990999,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice 2990440,
    France

    Site Not Available

  • APHP La Pitié

    Paris,
    France

    Site Not Available

  • APHP La Pitié

    Paris 2988507,
    France

    Site Not Available

  • Chu Poitiers

    Poitiers,
    France

    Site Not Available

  • Chu Poitiers

    Poitiers 2986495,
    France

    Site Not Available

  • Institut Jean Godinot

    Reims,
    France

    Site Not Available

  • Institut Jean Godinot

    Reims 2984114,
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes,
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes 2983990,
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen,
    France

    Site Not Available

  • Chu Rouen

    Rouen,
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen 2982652,
    France

    Site Not Available

  • Chu Rouen

    Rouen 2982652,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain 2979590,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    St HERBLAIN,
    France

    Site Not Available

  • IUCT

    Toulouse,
    France

    Site Not Available

  • IUCT

    Toulouse 2972315,
    France

    Site Not Available

  • Chu Tours

    Tours,
    France

    Site Not Available

  • Chu Tours

    Tours 2972191,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif 2968705,
    France

    Site Not Available

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