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
Centre Francois Baclesse
348 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria8
- 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
Interventions
Standard post-operative radiotherapy without flap sparing (current practice)
Post-operative radiotherapy with flap sparing
Locations(25)
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NCT06798922