Informations générales (source: ClinicalTrials.gov)
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
Interventional
Phase 3
Centre Francois Baclesse (Voir sur ClinicalTrials)
mars 2025
mars 2034
23 juillet 2026
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)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | France NGUYEN | 09/06/2026 14:00:08 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| INSTITUT GUSTAVE ROUSSY | France NGUYEN | Contact (sur clinicalTrials) | |||
| USLD PITIE SALPETRIERE APHP | Cyrus Chargari | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - Rennes - France | BATY Manon | Contact (sur clinicalTrials) | |||
| Centre Frédéric Joliot - Rouen - France | MARTINAGE | Contact (sur clinicalTrials) | |||
| Centre Guillaume le Conquérant - Le Havre - France | Laurent MARTIN, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - Cherbourg - France | KAO | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Michel LAPEYRE | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Séverine RACADOT | Contact (sur clinicalTrials) | |||
| Chu Poitiers - Poitiers - France | Florent CARSUZAA | Contact (sur clinicalTrials) | |||
| Chu Reims - Reims - France | BRENET | Contact (sur clinicalTrials) | |||
| Chu Rouen - Rouen - France | Sophie DENEUVE | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Angers - France | Aurore GOINEAU | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM Marseille - Marseille - France | Stéphanie WONG-HEE-KAM, MD | Contact (sur clinicalTrials) | |||
| Centre Antoine Lacassagne - Nice - France | Deborah ALOI, MD | Contact (sur clinicalTrials) | |||
| Centre de la Baie - Avranches - France | DUMONT LECOMTE | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - Caen - France | Juliette THARIAT, Professor | Contact (sur clinicalTrials) | |||
| Centre Georges-François Leclerc - Dijon - France | Noémie VULQUIN, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Ovidiu VERESEZAN | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille - France | Ysaure ROQUETTE | Contact (sur clinicalTrials) | |||
| CHIC - Créteil - France | Soumya ANANE-ABROUS, MD | Contact (sur clinicalTrials) | |||
| Chu Amiens - Amiens - France | Alexandre COUTTE | Contact (sur clinicalTrials) | |||
| CHU CAEN - Caen - France | Alexis VEYSSIERE, MD | Contact (sur clinicalTrials) | |||
| Chu Limoges - Limoges - France | SERRE | Contact (sur clinicalTrials) | |||
| Chu Tours - Tours - France | Sofia BAKKAR, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Nancy - France | Sophie RENARD | Contact (sur clinicalTrials) | |||
| Institut Jean Godinot - Reims - France | Arnaud BEDDOCK | Contact (sur clinicalTrials) | |||
| Institut Régional du Cancer Val D'aurelle - Montpellier - France | Pierre BOISSELIER, MD | Contact (sur clinicalTrials) | |||
| IUCT - Toulouse - France | Lucie PIRAM | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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