Bastit Vianney, Lequesne Justine, Leconte Alexandra, Deneuve Sophie, Mouawad Francois, Quak Elske, Jeanne Corinne, Clarisse Bénédicte, Thariat Juliette
Department of Otolaryngology-Head and Neck Surgery, CHU de Caen, Avenue de La Côte de Nacre, Caen, 14000, France.
Department of Clinical Research, Center François Baclesse, Avenue du Général Harris, Caen, France.
BMC Cancer. 2025 Mar 27;25(1):551. doi: 10.1186/s12885-025-13913-7.
In cases of prevalent lymphadenopathy in the head and neck cancer region, identifying the primary tumor site allows for more precise radiotherapy targeting. This improves treatment by reducing the volumes of mucosal irradiation and potentially lowering morbidity. An extensive diagnostic workup, including FDG PET-CT imaging and bilateral tonsillectomy, has been shown to identify the primary cancer in 60% of cases. Mucosectomy of the tongue base holds promise for detecting additional primary sites. When performed using minimally invasive endoscopic techniques such as transoral robotic surgery (TORS) or transoral laser microsurgery (TLM), mucosectomy results in minimal morbidity. However, the effectiveness of tongue base mucosectomy in detecting primary tumors has yet to be evaluated in a randomized trial involving patients with lymphadenopathy of unknown primary.
The RoboCUP trial is a multicentre, open-label, randomized, non-comparative phase 2 trial aiming to evaluate the benefit of bilateral TORS or TLM-assisted tongue base mucosectomy in association to tonsillectomy in the assessment of prevalent cervical lymphadenopathy with a negative exhaustive diagnostic workup. The main endpoint is the proportion of patients with detection of a primary cancer. Surgery will consist in tongue base mucosectomy plus tonsillectomy in the experimental arm, and the standard of care, i.e. tonsillectomy alone in the control arm. Patients will then be treated by intensity modulated radiotherapy, possibly with chemotherapy as radiosensitizer, per current guidelines. Using a single-stage Fleming design, 36 patients will be enrolled in the experimental arm, and 36 patients in the control arm.
This trial aims to improve the diagnostic performances, i.e. detection of primary tumor, in patients with head and neck carcinoma of unknown primary. It is expected that the subsequent therapeutic changes could enhance radiotherapy accuracy, and could improve the prognosis, toxicity profiles and quality-of-life of patients.
NCT04767048, registered February, 19, 2021.
在头颈部癌区域存在普遍性淋巴结病的情况下，确定原发肿瘤部位有助于更精确地进行放射治疗靶向。这通过减少黏膜照射体积并可能降低发病率来改善治疗效果。广泛的诊断检查，包括氟代脱氧葡萄糖正电子发射断层扫描-计算机断层扫描（FDG PET-CT）成像和双侧扁桃体切除术，已被证明在60%的病例中可确定原发癌。舌根黏膜切除术有望发现更多的原发部位。当使用经口机器人手术（TORS）或经口激光显微手术（TLM）等微创内镜技术进行时，黏膜切除术导致的发病率极低。然而，舌根黏膜切除术在检测原发肿瘤方面的有效性尚未在涉及原发灶不明的淋巴结病患者的随机试验中得到评估。
RoboCUP试验是一项多中心、开放标签、随机、非对照的2期试验，旨在评估双侧TORS或TLM辅助的舌根黏膜切除术联合扁桃体切除术在评估广泛性颈部淋巴结病且全面诊断检查为阴性时的益处。主要终点是检测到原发癌的患者比例。试验组的手术将包括舌根黏膜切除术加扁桃体切除术，对照组为标准治疗，即仅行扁桃体切除术。然后，根据当前指南，患者将接受调强放射治疗，可能联合化疗作为放射增敏剂。采用单阶段弗莱明设计，试验组将招募36例患者，对照组将招募36例患者。
本试验旨在提高原发灶不明的头颈部癌患者的诊断性能，即检测原发肿瘤。预计随后的治疗改变可提高放射治疗的准确性，并可改善患者的预后、毒性特征和生活质量。
NCT04767048，于2021年2月19日注册。
