Jia Ruinuo, Yin Weijiao, Li Shuoguo, Li Ruonan, Yang Junqiang, Shan Tanyou, Zhou Dan, Wang Wei, Wan Lixin, Zhou Fuyou, Gao Shegan
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Biotherapy Centre and Cancer Centre, The First Affiliated Hospital of Zhengzhou University, China Cancer Hospital, Zhengzhou, China.
Trials. 2019 Apr 11;20(1):206. doi: 10.1186/s13063-019-3316-5.
Surgery is the gold standard treatment for local advanced disease, while definitive concurrent chemoradiotherapy (DCRT) is recommended for those who are medically unable to tolerate major surgery or medically fit patients who decline surgery. The primary aim of this trial is to compare the outcomes in Chinese patients with oesophageal squamous cell cancer with locally advanced resectable disease who have received either surgery or DCRT.
METHODS/DESIGN: One hundred ninety-six patients with T1bN + M0 or T2-4aN0-2 M0 oesophageal squamous cell cancer will be randomised to the DCRT group or the surgery group. In the DCRT group, patients will be given intensity-modulated radiation therapy (IMRT) with 50 Gy/25 fractions and basic chemotherapy with 5-fluorouracil regimens. In the surgery group, patients will receive neoadjuvant chemoradiotherapy (NCRT) and standard oesophagectomy. Five years of follow-up will be scheduled for patients. The primary endpoints are 2-year/5-year overall survival; the secondary endpoints are 2-year/5-year progression-free survival, treatment-related adverse events and the patients' quality of life. The main evaluation methods include oesophagoscopy, endoscopic ultrasonography and biopsy, oesophageal barium meal, computed tomography, positron emission tomography-computed tomography, blood tests and questionnaires.
The preponderant oesophageal cancer pathology type is dramatically different in western Caucasian and Asian oesophageal cancer patients: Caucasian patients present with 80% adenocarcinomas, and Asians patients present with 95% squamous cell carcinomas. This phenomenon needs more in-depth studies to elucidate the differences in these populations. Based on the results of this study, we will show whether DCRT will benefit patients more than oesophagectomy. This study will contribute more evidence to the management of oesophageal squamous cell cancer.
ClinicalTrials.gov, NCT02972372 . Registered on 26 November 2016.
手术是局部晚期疾病的金标准治疗方法，而对于那些无法耐受大型手术的患者或拒绝手术的身体状况适宜的患者，推荐进行根治性同步放化疗（DCRT）。本试验的主要目的是比较接受手术或DCRT的局部晚期可切除食管鳞状细胞癌中国患者的治疗结果。
方法/设计：196例T1bN+M0或T2-4aN0-2M0食管鳞状细胞癌患者将被随机分为DCRT组或手术组。在DCRT组中，患者将接受50 Gy/25次分割的调强放射治疗（IMRT）和含5-氟尿嘧啶方案的基本化疗。在手术组中，患者将接受新辅助放化疗（NCRT）和标准食管切除术。将为患者安排5年的随访。主要终点为2年/5年总生存率；次要终点为2年/5年无进展生存率、治疗相关不良事件和患者生活质量。主要评估方法包括食管镜检查、内镜超声检查和活检、食管钡餐、计算机断层扫描、正电子发射断层扫描-计算机断层扫描、血液检查和问卷调查。
西方白种人和亚洲食管癌患者的优势食管癌病理类型存在显著差异：白种人患者80%为腺癌，亚洲患者95%为鳞状细胞癌。这种现象需要更深入的研究来阐明这些人群之间的差异。基于本研究的结果，我们将表明DCRT是否比食管切除术更能使患者获益。本研究将为食管鳞状细胞癌的治疗提供更多证据。
ClinicalTrials.gov，NCT02972372。于2016年11月26日注册。
