Thariat Juliette, Leconte Alexandra, Lequesne Justine, Vela Anthony, Carsuzaa Florent, Dejean Catherine, Renard Sophie, Pereira Sandrine, Lebars Sabrina, Nadin Lawrence, Plisson Laetitia, Bastit Vianney, Woisard Virginie, Hervieu-Klisnick Zazie, Lasne-Cardon Audrey, Clarisse Bénédicte
Department of Radiation Oncology, Comprehensive Cancer Center François Baclesse, Université de Caen Normandie, Caen, France
Department of Clinical Research, Centre François Baclesse Centre de Lutte Contre le Cancer, Caen, France.
BMJ Open. 2025 Sep 14;15(9):e109094. doi: 10.1136/bmjopen-2025-109094.
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.
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.
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.
NCT06798922.
口腔癌（OCC）的标准治疗依赖于手术以及晚期或存在不良因素时的术后放疗（poRT）。在超过75%的病例中，使用皮瓣的重建手术旨在恢复因肿瘤切除而丧失的功能。当前的poRT计划和勾画指南忽略了皮瓣的存在。可以推测，保留皮瓣的poRT可能有助于降低放射性毒性并改善功能结局，同时不影响局部原发灶控制。OPTIFLAP试验评估在OCC患者中，与传统的不考虑皮瓣的放疗相比，保留皮瓣的局部区域控制是否不劣，同时降低治疗相关毒性并改善功能结局。
OPTIFLAP研究是一项法国的多中心、1:1随机、III期对照试验。它将招募348例有皮瓣的OCC患者。招募工作正在进行中，首例入组于2025年7月2日开始，计划持续48个月。主要结局是在接受poRT的完全切除的OCC中，与不考虑皮瓣的放疗（按照标准常规做法）相比，保留皮瓣的2年局部区域控制率不劣。关键次要结局包括毒性发生率、局部区域无复发生存率、无进展生存率、总生存率、生活质量、功能结局（通过头颈癌性能状态量表、MD安德森吞咽障碍量表（自填问卷）和发声障碍指数（自填问卷）评估）、皮瓣剂量以及根据剂量学参数各治疗组之间的结局。该试验纳入了针对个体放射敏感性、唾液微生物群演变、皮瓣变化的放射组学和剂量组学的转化辅助研究，以及医学经济学评估。
研究方案已获得东部第三医学伦理委员会（2025年1月；参考号24.05832.000442）和法国医疗卫生产品安全局（2024年12月；ID-RCB：2024-A01764-43）的批准，并得到所有参与中心审查委员会的认可。将从所有参与者处获得书面知情同意书。研究结果将发表在国际同行评审的科学期刊上，并在相关科学会议上展示。
NCT06798922。
