Status:
RECRUITING
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Oral Cavity Carcinoma
Flap
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 * Contro...
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 * Contro...
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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2034
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT06798922
Start Date
March 1 2025
End Date
March 1 2034
Last Update
March 3 2026
Active Locations (25)
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1
Chu Amiens
Amiens, France
2
Institut de Cancérologie de l'Ouest
Angers, France
3
Centre François Baclesse
Caen, France
4
CHU CAEN
Caen, France