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