Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers (NCT06798922) | Clinical Trial Compass
RecruitingPhase 3
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
France348 participantsStarted 2025-03-01
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
loco-regional control rate
Timeframe: 2 years after the end of postoperative radiotherapy