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Recruiting
NCT06798922
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
Conditions: Oral Cavity Carcinoma, Flap, Radiotherapy, Adjuvant, Reconstruction Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 348
Sponsor: Centre Francois Baclesse
Location: Chu Amiens Amiens
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)
* 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
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
Source: ClinicalTrials.gov (NCT06798922). StuddyBuddy aggregates publicly available trial information.