Oral Cavity CarcinomaPhase 3OPTIFLAPNCT06798922
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
A Phase 3 study testing Standard post-operative radiotherapy without flap sparing (current practice) and Post-operative radiotherapy with flap sparing in people with Oral Cavity Carcinoma and Flap, run by Centre Francois Baclesse at 30 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Carcinoma, Flap, Radiotherapy, Adjuvant
- What is being tested?
- Standard post-operative radiotherapy without flap sparing (current practice) and Post-operative radiotherapy with flap sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 30 sitesFrance
- Study dates
- 1 Mar 2025to 1 Mar 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Perioperative immunotherapy is allowed (neoadjuvant and/or adjuvant setting)
- Patient must have signed a written informed consent form prior to any trial specific procedures
- Patient affiliated to the social security system
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites, 30 recruiting
- Not yet recruiting
Chu Amiens
Amiens
Alexandre COUTTE, Coutte.Alexandre@chu-amiens.fr
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Angers
Aurore GOINEAU, aurore.goineau@ico.unicancer.fr
- Not yet recruiting
Centre de la Baie
Avranches
DUMONT LECOMTE, d.dumont@centredelabaie.fr
- Recruiting
Centre François Baclesse
Caen
Juliette THARIAT, Professor, 33231455050, j.thariat@baclesse.unicancer.fr
- Not yet recruiting
CHU CAEN
Caen
Alexis VEYSSIERE, MD, veyssiere-a@chu-caen.fr
- Not yet recruiting
Centre Hospitalier
Cherbourg
KAO, william.kao@ch-cotentin.fr
- Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand
Michel LAPEYRE, Michel.LAPEYRE@clermont.unicancer.fr
- Not yet recruiting
CHIC
Créteil
Soumya ANANE-ABROUS, MD, 0157022700, soumya.anane@chicreteil.fr
- Not yet recruiting
Centre Georges-François Leclerc
Dijon
Noémie VULQUIN, MD
- Not yet recruiting
Centre Guillaume le Conquérant
Le Havre
Laurent MARTIN, MD
- Not yet recruiting
Centre Hospitalier
Libourne
Muriel GARCIA RAMIREZ, 05 57 55 70 57, MURIEL.GARCIA-RAMIREZ@ch-libourne.fr
- Not yet recruiting
Centre Oscar Lambret
Lille
Ysaure ROQUETTE, investigation@o-lambret.fr
- Not yet recruiting
Chu Limoges
Limoges
SERRE, Raphael.SERRE@chu-limoges.fr
- Not yet recruiting
Centre Léon Bérard
Lyon
Séverine RACADOT, severine.racadot@lyon.unicancer.fr
- Not yet recruiting
APHM Marseille
Marseille
Stéphanie WONG-HEE-KAM, MD
- Not yet recruiting
Institut Régional du Cancer Val D'aurelle
Montpellier
Pierre BOISSELIER, MD
- Not yet recruiting
Institut de Cancérologie de Lorraine
Nancy
Sophie RENARD, s.renard@nancy.unicancer.fr
- Not yet recruiting
Centre Antoine Lacassagne
Nice
Deborah ALOI, MD
- Not yet recruiting
APHP La Pitié
Paris
Cyrus Chargari, cyrus.chargari@aphp.fr
- Not yet recruiting
Chu Poitiers
Poitiers
Florent CARSUZAA, florent.carsuzaa@chu-poitiers.fr
- Not yet recruiting
Chu Reims
Reims
BRENET, ebrenet@chu-reims.fr
- Not yet recruiting
Institut Jean Godinot
Reims
Arnaud BEDDOCK, arnaud.beddok@reims.unicancer.fr
- Not yet recruiting
Centre Eugène Marquis
Rennes
BATY Manon, m.baty@rennes.unicancer.fr
- Not yet recruiting
Centre Frédéric Joliot
Rouen
MARTINAGE, geoffrey.martinage@centrefredericjoliot.fr
- Not yet recruiting
Centre Henri Becquerel
Rouen
Ovidiu VERESEZAN, ovidiu.veresezan@chb.unicancer.fr
- Not yet recruiting
Chu Rouen
Rouen
Sophie DENEUVE, sophie.deneuve@chu-rouen.fr
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain
Melanie DORE, melanie.dore@ico.unicancer.fr
- Not yet recruiting
IUCT
Toulouse
Lucie PIRAM, piram.lucie@iuct-oncopole.fr
- Not yet recruiting
Chu Tours
Tours
Sofia BAKKAR, MD
- Not yet recruiting
Institut Gustave Roussy
Villejuif
France NGUYEN, th.nguyen@gustaveroussy.fr
About this study
Official title: Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
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)
Read the 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.
- Being tested
- Standard post-operative radiotherapy without flap sparing (current practice), Post-operative radiotherapy with flap sparing
- Keywords
- protontherapy, flap, oral cavity carnicoma, radiotherapy, IMRT
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard post-operative radiotherapy without flap sparing (current practice)Radiation
Standard post-operative radiotherapy without flap sparing (current practice)
Post-operative radiotherapy with flap sparingRadiation
Post-operative radiotherapy with flap sparing
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | Active comparator | Standard IMRT or proton therapy practice, usual CTV definition Receives: Radiation: Standard post-operative radiotherapy without flap sparing (current practice) |
| Experimental arm | Experimental | IMRT or proton therapy with flap sparing Receives: Radiation: Post-operative radiotherapy with flap sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after the end of postoperative radiotherapy
Secondary outcomes (1)
Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities
Rate of Ear-Nose-Throat (ENT) toxicities among cavity cancer patients with a flap, defined as the proportion of oral cavity cancer patients with at least two ENT toxicities grade ≥ 2 according to NCI-CTCAE v5.0
Measured: within 12 months after postoperative radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Cavity CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798922
- Sponsor's protocol ID
- 2024-A01764-43
- Acronym
- OPTIFLAP
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 14;15(9):e109094. doi: 10.1136/bmjopen-2025-109094.
PubMed 40953868
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT06798922
- Acronym / sponsor ID
- OPTIFLAP / 2024-A01764-43
- Keywords
- protontherapy, flap, oral cavity carnicoma, radiotherapy, IMRT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2034 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | Active comparator | Radiation: Standard post-operative radiotherapy without flap sparing (current practice)Standard IMRT or proton therapy practice, usual CTV definition |
| Experimental arm | Experimental | Radiation: Post-operative radiotherapy with flap sparingIMRT or proton therapy with flap sparing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard post-operative radiotherapy without flap sparing (current practice)Standard post-operative radiotherapy without flap sparing (current practice) | Radiation | Standard arm |
| Post-operative radiotherapy with flap sparingPost-operative radiotherapy with flap sparing | Radiation | Experimental arm |
Primary outcome
loco-regional control rate
Time frame: 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
1 secondary outcome
Proportion of patients with acute and late Ear-Nose-Throat (ENT) toxicities
Time frame: within 12 months after postoperative radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 40953868Thariat 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.
Related trials for Oral Cavity Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard post-operative radiotherapy without flap sparing (current practice) and Post-operative radiotherapy with flap sparing in people with Oral Cavity Carcinoma and Flap, run by Centre Francois Baclesse at 30 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliette THARIAT, Professor (33231455050, j.thariat@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
loco-regional control rate (time frame: 2 years after the end of postoperative radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.