{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T16:44:42Z","timestamp":1790441082150,"version":"4.1.0"},"reference-count":23,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2025,9,14]],"date-time":"2025-09-14T00:00:00Z","timestamp":1757808000000},"content-version":"unspecified","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"French Cancer Institute and French Health Ministry","award":["PHRC-K24-069 \/ DGOS_19015"],"award-info":[{"award-number":["PHRC-K24-069 \/ DGOS_19015"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,8,28]]},"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06798922\">NCT06798922<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-109094","type":"journal-article","created":{"date-parts":[[2025,9,15]],"date-time":"2025-09-15T05:25:43Z","timestamp":1757913943000},"page":"e109094","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Flap sparing in postoperative radiotherapy versus standard flap-agnostic radiotherapy of oral cavity cancers (OPTIFLAP): protocol for a de-escalation, randomised, non-inferiority, phase III trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06798922","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06798922","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06798922","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7853-5468","authenticated-orcid":false,"given":"Juliette","family":"Thariat","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Comprehensive Cancer Center Fran\u00e7ois Baclesse, Universit\u00e9 de Caen Normandie, Caen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Leconte","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, Centre Fran\u00e7ois Baclesse Centre de Lutte Contre le Cancer, Caen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justine","family":"Lequesne","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, Centre Fran\u00e7ois Baclesse Centre de Lutte Contre le Cancer, Caen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Vela","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Centre Fran\u00e7ois Baclesse Centre de Lutte Contre le Cancer, Caen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florent","family":"Carsuzaa","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery, Centre Hospitalier Universitaire de Poitiers, Poitiers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Dejean","sequence":"additional","affiliation":[{"name":"Department of Radiation Physics, Centre Antoine Lacassagne, Nice, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Renard","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology. 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