Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard post-operative radiotherapy without flap sparing (current practice), Post-operative radiotherapy with flap sparing.
- Who it may be relevant to
- Registry conditions: Oral Cavity Carcinoma, Flap, Radiotherapy, Adjuvant, Reconstruction Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
Overview
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.
Interventions
- Radiation Standard post-operative radiotherapy without flap sparing (current practice)
Standard post-operative radiotherapy without flap sparing (current practice) - Radiation Post-operative radiotherapy with flap sparing
Post-operative radiotherapy with flap sparing
Primary outcome measures
- loco-regional control rate [Time frame: 2 years after the end of postoperative radiotherapy]
Secondary outcome measures (1)
- Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities [Time frame: within 12 months after postoperative radiotherapy]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 30 centers
- Chu Amiens — Amiens
- Institut de Cancérologie de l'Ouest — Angers
- Centre de la Baie — Avranches
- Centre François Baclesse — Caen
- CHU CAEN — Caen
- Centre Hospitalier — Cherbourg
- Centre Jean Perrin — Clermont-Ferrand
- CHIC — Créteil
- … and 22 more centers
Publications
- 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 PMID 40953868
Identifiers
NCT: NCT06798922 · 2024-A01764-43