Clinical trial · Interventional
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
NCT06798922CI-TRIAL-00118909OPTIFLAPrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Flap | — | UNRESOLVED | — |
| Oral Cavity Carcinoma | Oral Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiotherapy, Adjuvant | — | UNRESOLVED | — |
| Reconstruction Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative radiotherapy with flap sparing | Radiation | — | UNRESOLVED |
| Standard post-operative radiotherapy without flap sparing (current practice) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard arm
- description
- Standard IMRT or proton therapy practice, usual CTV definition
- interventionNames
- Radiation: Standard post-operative radiotherapy without flap sparing (current practice)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- IMRT or proton therapy with flap sparing
- interventionNames
- Radiation: Post-operative radiotherapy with flap sparing
Primary outcomes (1)
- measure
- loco-regional control rate
- timeFrame
- 2 years after the end of postoperative radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDThariat 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 40953868