Studies

Interventional Recruiting Phase 3

NCT06798922 on ClinicalTrials.gov

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Official title: Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial

  • Sponsor: Centre François Baclesse
  • Enrollment: 348 (Estimated)
  • Study start: 2025-03-01 (Actual)
  • Primary completion: 2031-03-01 (Estimated)
  • Study completion: 2034-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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)

Conditions

  • Oral Cavity Carcinoma
  • Flap
  • Radiotherapy, Adjuvant
  • Reconstruction Surgery

Intervention / Treatment

  • Radiation: Standard post-operative radiotherapy without flap sparing (current practice)
  • Radiation: Post-operative radiotherapy with flap sparing

Primary Outcome Measures

  • loco-regional control rate (2 years after the end of postoperative radiotherapy)
    To evaluate whether flap sparing yields non-inferior 2-year loco-regional control rate as flap-agnostic radiotherapy (as per standard routine practice) in completely resected oral cavity carcinomas undergoing postoperative radiotherapy

Countries

France

Locations and Investigators

  • Chu Amiens, Amiens, France (Not yet recruiting)
    • Alexandre COUTTE
  • Institut de Cancérologie de l'Ouest, Angers, France (Not yet recruiting)
    • Aurore GOINEAU
  • Centre de la Baie, Avranches, France (Not yet recruiting)
    • DUMONT LECOMTE
  • Centre François Baclesse, Caen, France (Recruiting)
    • Juliette THARIAT, Professor
  • CHU CAEN, Caen, France (Not yet recruiting)
    • Alexis VEYSSIERE, MD
  • Centre Hospitalier, Cherbourg, France (Not yet recruiting)
    • KAO
  • Centre Jean Perrin, Clermont-Ferrand, France (Not yet recruiting)
    • Michel LAPEYRE
  • CHIC, Créteil, France (Not yet recruiting)
    • Soumya ANANE-ABROUS, MD
  • Centre Georges-François Leclerc, Dijon, France (Not yet recruiting)
    • Noémie VULQUIN, MD
  • Centre Guillaume le Conquérant, Le Havre, France (Not yet recruiting)
    • Laurent MARTIN, MD
  • Centre Hospitalier, Libourne, France (Not yet recruiting)
    • Muriel GARCIA RAMIREZ
  • Centre Oscar Lambret, Lille, France (Not yet recruiting)
    • Ysaure ROQUETTE
  • Chu Limoges, Limoges, France (Not yet recruiting)
    • SERRE
  • Centre Léon Bérard, Lyon, France (Not yet recruiting)
    • Séverine RACADOT
  • APHM Marseille, Marseille, France (Not yet recruiting)
    • Stéphanie WONG-HEE-KAM, MD
  • Institut Régional du Cancer Val D'aurelle, Montpellier, France (Not yet recruiting)
    • Pierre BOISSELIER, MD
  • Institut de Cancérologie de Lorraine, Nancy, France (Not yet recruiting)
    • Sophie RENARD
  • Centre Antoine Lacassagne, Nice, France (Not yet recruiting)
    • Deborah ALOI, MD
  • APHP La Pitié, Paris, France (Not yet recruiting)
    • Cyrus Chargari
  • Chu Poitiers, Poitiers, France (Not yet recruiting)
    • Florent CARSUZAA
  • Chu Reims, Reims, France (Not yet recruiting)
    • BRENET
  • Institut Jean Godinot, Reims, France (Not yet recruiting)
    • Arnaud BEDDOCK
  • Centre Eugène Marquis, Rennes, France (Not yet recruiting)
    • BATY Manon
  • Centre Frédéric Joliot, Rouen, France (Not yet recruiting)
    • MARTINAGE
  • Centre Henri Becquerel, Rouen, France (Not yet recruiting)
    • Ovidiu VERESEZAN
  • Chu Rouen, Rouen, France (Not yet recruiting)
    • Sophie DENEUVE
  • Institut de Cancérologie de l'Ouest, Saint-Herblain, France (Not yet recruiting)
    • Melanie DORE
  • IUCT, Toulouse, France (Not yet recruiting)
    • Lucie PIRAM
  • Chu Tours, Tours, France (Not yet recruiting)
    • Sofia BAKKAR, MD
  • Institut Gustave Roussy, Villejuif, France (Not yet recruiting)
    • France NGUYEN