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Patients with oral cavity cancer treated by reconstructive surgery with a flap.
Patients will be treated in the study for :
Patients with oral cavity cancer treated by reconstructive surgery with a flap.
Patients will be treated in the study for :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard arm | Active Comparator | Standard IMRT or proton therapy practice, usual CTV definition |
|
| Experimental arm | Experimental | IMRT or proton therapy with flap sparing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard post-operative radiotherapy without flap sparing (current practice) | Radiation | Standard post-operative radiotherapy without flap sparing (current practice) |
|
| Measure | Description | Time Frame |
|---|---|---|
| loco-regional control rate | 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 | 2 years after the end of postoperative radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities | Rate of Ear-Nose-Throat (ENT) toxicities among cavity cancer patients with a flap, defined as the proportion of oral cavity cancer patients with at least two ENT toxicities grade ≥ 2 according to NCI-CTCAE v5.0 | within 12 months after postoperative radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliette THARIAT, Professor | Contact | 33231455050 | j.thariat@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Not yet recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953868 | Derived | Thariat J, Leconte A, Lequesne J, Vela A, Carsuzaa F, Dejean C, Renard S, Pereira S, Lebars S, Nadin L, Plisson L, Bastit V, Woisard V, Hervieu-Klisnick Z, Lasne-Cardon A, Clarisse B. Flap sparing in postoperative radiotherapy versus standard flap-agnostic radiotherapy of oral cavity cancers (OPTIFLAP): protocol for a de-escalation, randomised, non-inferiority, phase III trial. BMJ Open. 2025 Sep 14;15(9):e109094. doi: 10.1136/bmjopen-2025-109094. |
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| Post-operative radiotherapy with flap sparing | Radiation | Post-operative radiotherapy with flap sparing |
|
| Institut de Cancérologie de l'Ouest | Not yet recruiting | Angers | France |
|
| Centre François Baclesse | Recruiting | Caen | France |
|
| CHU CAEN | Not yet recruiting | Caen | France |
|
| Centre Jean Perrin | Not yet recruiting | Clermont-Ferrand | France |
|
| CHIC | Not yet recruiting | Créteil | France |
|
| Centre Georges-François Leclerc | Not yet recruiting | Dijon | France |
|
| Centre Guillaume le Conquérant | Not yet recruiting | Le Havre | France |
|
| Centre Hospitalier | Not yet recruiting | Libourne | France |
|
| Centre Oscar Lambret | Not yet recruiting | Lille | France |
|
| Centre Léon Bérard | Not yet recruiting | Lyon | France |
|
| APHM Marseille | Not yet recruiting | Marseille | France |
|
| Institut Régional du Cancer Val D'aurelle | Not yet recruiting | Montpellier | France |
|
| Institut de Cancérologie de Lorraine | Not yet recruiting | Nancy | France |
|
| Centre Antoine Lacassagne | Not yet recruiting | Nice | France |
|
| APHP La Pitié | Not yet recruiting | Paris | France |
|
| Chu Poitiers | Not yet recruiting | Poitiers | France |
|
| Institut Jean Godinot | Not yet recruiting | Reims | France |
|
| Centre Eugène Marquis | Not yet recruiting | Rennes | France |
|
| Centre Henri Becquerel | Not yet recruiting | Rouen | France |
|
| Chu Rouen | Not yet recruiting | Rouen | France |
|
| Institut de Cancérologie de l'Ouest | Not yet recruiting | Saint-Herblain | France |
|
| IUCT | Not yet recruiting | Toulouse | France |
|
| Chu Tours | Not yet recruiting | Tours | France |
|
| Institut Gustave Roussy | Not yet recruiting | Villejuif | France |
|
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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