背景:对于本地区域高级,但是经口可切除的口咽癌(OPSCC),目前的护理标准包括手术切除和适应风险的辅助(化学)放疗,或明确的放化疗,有或没有抢救手术。虽然OPSCC的经口手术在过去十年中有所增加,例如在美国,由于经口机器人手术,这种治疗方法在德国有着悠久的历史。与盎格鲁-撒克逊国家相比,在德国,经口手术方法已被频繁使用,以治疗患有口腔疾病的患者。下咽和喉癌。经口激光显微外科手术(TLM)自70年代初推出以来已有悠久的传统。迄今为止,在一项关于疾病控制和生存的随机试验中,经口可切除OPSCC的不同治疗方法没有直接相互比较.这项研究的目的是比较初次经口手术和最终放化疗的可切除的OPSCC,特别是在地方和区域控制方面。
方法:TopROC是一种前瞻性,双臂,开放标签,多中心,随机化,和对照比较有效性研究。符合条件的患者年龄≥18岁,未接受治疗,经组织学证实的OPSCC(T1,N2a-c,M0;T2,N1-2c,M0;T3,N0-2c,M0UICC版本。7)适合经口切除术。280名患者将被随机分配(1:1)接受手术治疗(A组)或放化疗(B组)。护理治疗的标准将根据日常实践进行。A组包括经口手术切除和颈淋巴结清扫术,然后进行风险适应的辅助治疗。在B组接受治疗的患者接受标准放化疗,残余肿瘤可接受抢救手术。计划进行为期3年的后续访问。主要终点是局部或局部故障(LRF)的时间。次要终点包括总体和无病生存率,毒性,和患者报告的结果。大约有20个中心将在德国参与。该试验由德国癌症援助组织支持,并伴随着一个科学支持计划。
结论:这项研究将揭示初级放化疗与初级放化疗策略的迫切需要的随机比较主要手术方法。作为一项比较有效性试验,它旨在根据每日临床常规中的两种既定方案提供数据.
背景:NCT03691441于2018年10月1日注册-回顾性注册。
BACKGROUND: For loco-regionally advanced, but transorally resectable oropharyngeal cancer (OPSCC), the current standard of care includes surgical resection and risk-adapted adjuvant (chemo) radiotherapy, or definite chemoradiation with or without salvage surgery. While transoral surgery for OPSCC has increased over the last decade for example in the United States due to transoral robotic surgery, this treatment approach has a long history in Germany. In contrast to Anglo-Saxon countries, transoral surgical approaches have been used frequently in Germany to treat patients with oro-, hypopharyngeal and laryngeal cancer. Transoral laser microsurgery (TLM) has had a long tradition since its introduction in the early 70s. To date, the different therapeutic approaches to transorally resectable OPSCC have not been directly compared to each other in a randomized trial concerning disease control and survival. The goal of this study is to compare initial transoral surgery to definitive chemoradiation for resectable OPSCC, especially with regards to local and regional control.
METHODS: TopROC is a prospective, two-arm, open label, multicenter, randomized, and controlled comparative effectiveness study. Eligible patients are ≥18 years old with treatment-naïve, histologically proven OPSCC (T1, N2a-c, M0; T2, N1-2c, M0; T3, N0-2c, M0 UICC vers. 7) which are amenable to transoral resection. Two hundred eighty patients will be randomly assigned (1:1) to surgical treatment (arm A) or chemoradiation (arm B). Standard of care treatment will be performed according to daily routine practice. Arm A consists of transoral surgical resection with neck dissection followed by risk-adapted adjuvant therapy. Patients treated in arm B receive standard chemoradiation, residual tumor may be subject to salvage surgery. Follow-up visits for 3 years are planned. Primary endpoint is time to local or locoregional failure (LRF). Secondary endpoints include overall and disease free survival, toxicity, and patient reported outcomes. Approximately 20 centers will be involved in Germany. This trial is supported by the German Cancer Aid and accompanied by a scientific support program.
CONCLUSIONS: This study will shed light on an urgently-needed randomized comparison of the strategy of primary chemoradiation vs. primary surgical approach. As a comparative effectiveness trial, it is designed to provide data based on two established regimens in daily clinical routine.
BACKGROUND: NCT03691441 Registered 1 October 2018 - Retrospectively registered.