[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"flap\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:flap":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100577486","phase-3-flap-sparing-in-postoperative-radiotherapy-of-oral-cavity-cancers-100577486",false,"NCT06798922","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","OPTIFLAP","Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Performance Status 0-2\n* 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\n* Quality of resection with margins \\> 1 mm\n* Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy)\n* Concomitant chemotherapy is allowed (stratification parameter)\n* Patient must have signed a written informed consent form prior to any trial specific procedures\n* Patient affiliated to the social security system\n\nExclusion Criteria:\n\n* Local flap (small size limiting IMRT modulation potential)\n* History of radiotherapy of head and neck area\n* Metastatic disease\n* History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)\n* Simultaneous participation in another clinical study may compromise the conduct of this study.\n* Pregnant or lactating women\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Patient deprived of freedom or under guardianship","ALL","18 Years",{"count":20,"type":21},348,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Patients with oral cavity cancer treated by reconstructive surgery with a flap.\n\nPatients will be treated in the study for :\n\n* Experimental arm: Post-operative radiotherapy with flap sparing\n* Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)",[27,28,29,30],"Oral Cavity Carcinoma","Flap","Radiotherapy, Adjuvant","Reconstruction Surgery",[32,33,34,35,36],"protontherapy","flap","oral cavity carnicoma","radiotherapy","IMRT","RECRUITING","2026-03-02",{"date":40,"type":41},"2026-03-03","ACTUAL",{"date":43,"type":41},"2025-03-01",{"date":45,"type":21},"2034-03-01",{"name":47,"class":48},"Centre Francois Baclesse","OTHER",25]