Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
OPTIFLAP
1 other identifier
interventional
348
1 country
25
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2025
Longer than P75 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 29, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2034
March 3, 2026
March 1, 2026
6 years
January 23, 2025
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities
within 12 months after postoperative radiotherapy
Study Arms (2)
Standard arm
ACTIVE COMPARATORStandard IMRT or proton therapy practice, usual CTV definition
Experimental arm
EXPERIMENTALIMRT or proton therapy with flap sparing
Interventions
Standard post-operative radiotherapy without flap sparing (current practice)
Post-operative radiotherapy with flap sparing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Chu Amiens
Amiens, France
Institut de Cancérologie de l'Ouest
Angers, France
Centre François Baclesse
Caen, France
CHU CAEN
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
CHIC
Créteil, France
Centre Georges-François Leclerc
Dijon, France
Centre Guillaume le Conquérant
Le Havre, France
Centre Hospitalier
Libourne, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
APHM Marseille
Marseille, France
Institut Régional du Cancer Val D'aurelle
Montpellier, France
Institut de Cancérologie de Lorraine
Nancy, France
Centre Antoine Lacassagne
Nice, France
APHP La Pitié
Paris, France
Chu Poitiers
Poitiers, France
Institut Jean Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Chu Rouen
Rouen, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
IUCT
Toulouse, France
Chu Tours
Tours, France
Institut Gustave Roussy
Villejuif, France
Related Publications (1)
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.
PMID: 40953868DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2025
First Posted
January 29, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
March 1, 2031
Study Completion (Estimated)
March 1, 2034
Last Updated
March 3, 2026
Record last verified: 2026-03