Ireland
--:--IST
Recruiting Phase 3

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

NCT06798922 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-03-01
Last updated
2026-07-22

Condition(s) studied

Oral Cavity CarcinomaFlapRadiotherapy, AdjuvantReconstruction Surgery

Investigational drug(s) / intervention(s)

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

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

Post-operative radiotherapy with flap sparing: Post-operative radiotherapy with flap sparing

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • 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

Trial sites (30)

FacilityCityRegionStatus
Chu Amiens Amiens France Not Yet Recruiting
Institut de Cancérologie de l'Ouest Angers France Not Yet Recruiting
Centre de la Baie Avranches France Not Yet Recruiting
Centre François Baclesse Caen France Recruiting
CHU CAEN Caen France Not Yet Recruiting
Centre Hospitalier Cherbourg France Not Yet Recruiting
Centre Jean Perrin Clermont-Ferrand France Not Yet Recruiting
CHIC Créteil France Not Yet Recruiting
Centre Georges-François Leclerc Dijon France Not Yet Recruiting
Centre Guillaume le Conquérant Le Havre France Not Yet Recruiting
Centre Hospitalier Libourne France Not Yet Recruiting
Centre Oscar Lambret Lille France Not Yet Recruiting
Chu Limoges Limoges France Not Yet Recruiting
Centre Léon Bérard Lyon France Not Yet Recruiting
APHM Marseille Marseille France Not Yet Recruiting
Institut Régional du Cancer Val D'aurelle Montpellier France Not Yet Recruiting
Institut de Cancérologie de Lorraine Nancy France Not Yet Recruiting
Centre Antoine Lacassagne Nice France Not Yet Recruiting
APHP La Pitié Paris France Not Yet Recruiting
Chu Poitiers Poitiers France Not Yet Recruiting
Chu Reims Reims France Not Yet Recruiting
Institut Jean Godinot Reims France Not Yet Recruiting
Centre Eugène Marquis Rennes France Not Yet Recruiting
Centre Frédéric Joliot Rouen France Not Yet Recruiting
Centre Henri Becquerel Rouen France Not Yet Recruiting
Chu Rouen Rouen France Not Yet Recruiting
Institut de Cancérologie de l'Ouest Saint-Herblain France Not Yet Recruiting
IUCT Toulouse France Not Yet Recruiting
Chu Tours Tours France Not Yet Recruiting
Institut Gustave Roussy Villejuif France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06798922 on ClinicalTrials.gov ↗ ← All trials in France