NCT06798922 Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
| NCT ID | NCT06798922 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Francois Baclesse |
| Condition | Oral Cavity Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 348 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2031-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 348 participants in total. It began in 2025-03-01 with a primary completion date of 2031-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06798922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Cavity Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06798922 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 348 participants.
Is NCT06798922 currently recruiting?
Yes, NCT06798922 is actively recruiting participants. Contact the research team at j.thariat@baclesse.unicancer.fr for enrollment information.
Where is the NCT06798922 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Avranches, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT06798922 clinical trial?
NCT06798922 is sponsored by Centre Francois Baclesse. The trial plans to enroll 348 participants.