Clinical trial NCT06798922: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Oral Cavity Carcinoma
Flap
Radiotherapy, Adjuvant
Reconstruction Surgery
Keywords: protontherapy
flap
oral cavity carnicoma
radiotherapy
IMRT
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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)

Detailed description: 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) Our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.

Eligibility criteria: 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 outcomes:
measure: loco-regional control rate
timeFrame: 2 years after the end of postoperative radiotherapy
Secondary outcomes:
measure: Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities
timeFrame: within 12 months after postoperative radiotherapy
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU CAEN
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Le Havre
country: France
facility: Centre Guillaume le Conquérant
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: APHM Marseille
city: Montpellier
country: France
facility: Institut Régional du Cancer Val D'aurelle
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: APHP La Pitié
city: Poitiers
country: France
facility: Chu Poitiers
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: Chu Rouen
city: St HERBLAIN
country: France
facility: Institut de Cancérologie de l'Ouest
city: Toulouse
country: France
facility: IUCT
city: Tours
country: France
facility: Chu Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: