Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Department of Radiation Oncology, Anhui Provincial Cancer Hospital/Division of Life Sciences and Medicine, University of Science and Technology of China, 230001, P.R. China, Hefei, People's Republic of China.
BMJ Open. 2022 Apr 25;12(4):e055273. doi: 10.1136/bmjopen-2021-055273.
Oesophageal squamous cell carcinoma (OSCC) is one of the most commonly occurring devastating tumours worldwide, including in China. To date, the standard care of patients with stage IV OSCC is systemic chemotherapy and palliative care, which results in poor prognosis. However, no consensus has been established regarding the role of radiotherapy in targeting the primary tumour in patients with stage IVa OSCC. Thus, the aim of this study is to assess the effectiveness of primary radiotherapy combined with S-1 and nedaplatin (NPD) chemotherapy in the patients with stage IV OSCC.
The study is a multicentre, open-label, randomised controlled trial. A total of 180 eligible patients with stage IV OSCC will be randomised into a study group (90 patients) and a control group (90 patients). Patients in the study group will receive radiotherapy to the primary tumour at a dose of 50.4 Gy combined with 4-6 cycles of S-1 and NPD chemotherapy. In the control group, patients will only receive 4-6 cycles of S-1 and NPD chemotherapy. The primary and secondary outcomes will be measured. The differences between the two groups will be statistically analysed with regard to overall survival, the progression-free survival and safety. All outcomes will be ascertained before treatment, after treatment and after the follow-up period.The results of this study will provide evidence on the role of radiotherapy in patients with stage IV OSCC in China, which will show new options for patients with advanced oesophageal cancer.
This study was approved by the Institutional Ethics Committee of The First Hospital Affiliated of Zhengzhou University (approval number: SS-2018-04).
The trial has been registered at the Chinese Clinical Trial Registry (ChiCTR1800015765) on 1 November 2018; retrospectively registered, http://www.chictr.org.cn/index.aspx.
食管鳞状细胞癌（ESCC）是全世界最常见的破坏性肿瘤之一，包括在中国。迄今为止，IV 期 ESCC 患者的标准治疗方法是全身化疗和姑息治疗，导致预后较差。然而，对于 IVa 期 ESCC 患者，放疗在靶向原发性肿瘤中的作用尚未达成共识。因此，本研究旨在评估放疗联合 S-1 和奈达铂（NPD）化疗治疗 IV 期 ESCC 患者的疗效。
本研究是一项多中心、开放标签、随机对照试验。共纳入 180 例符合条件的 IV 期 ESCC 患者，随机分为研究组（90 例）和对照组（90 例）。研究组患者接受 50.4Gy 的原发性肿瘤放疗，并联合 4-6 个周期的 S-1 和 NPD 化疗。对照组患者仅接受 4-6 个周期的 S-1 和 NPD 化疗。主要和次要结局将进行测量。将对两组患者的总生存期、无进展生存期和安全性进行统计学分析。所有结局将在治疗前、治疗后和随访期进行评估。
本研究结果将为中国 IV 期 ESCC 患者放疗的作用提供证据，为晚期食管癌患者提供新的选择。
本研究已获得郑州大学第一附属医院机构伦理委员会的批准（批准号：SS-2018-04）。
该试验于 2018 年 11 月 1 日在中国临床试验注册中心（ChiCTR1800015765）注册；追溯性注册，网址：http://www.chictr.org.cn/index.aspx。
