Comparative clinical studies of primary chemoradiotherapy versus S-1 and nedaplatin chemotherapy against stage IVb oesophageal squamous cell carcinoma: a multicentre open-label randomised controlled trial
Xin Wang,
Bo Song,
Yang Liu,
Yang Wang,
Yun Liu,
Liping Wu,
Xiaohong Wang,
Junqi Liu,
Anping Zheng,
Narasimha M Beeraka,
Kuo Chen,
Zhang Song,
Jianchao Luo,
Yanhui Cui,
Zhenhe Jia,
Xiangyu Song,
Hongqi Wang,
Xuefeng Qi,
Jinshan Ren,
Jixing Cai,
Xainying Fang,
Mikhail Y Sinelnikov,
Vladimir N Nikolenko,
M V Greeshma,
Ruitai Fan
Affiliations
Xin Wang
College of Health Management, China Medical University, Shenyang, Liaoning, China
Bo Song
2 Department of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Yang Liu
Department of Radiation Oncology, The Affiliated Tumor Hospital of Zhengzhou University, Zhengzhou, China
Yang Wang
Department of Neurosurgery, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China
Yun Liu
Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Liping Wu
Department of Radiation Oncology, The Xinxiang Central Hospital, Xinxiang, China
Xiaohong Wang
Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Junqi Liu
Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Anping Zheng
Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China
Narasimha M Beeraka
Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Kuo Chen
Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Zhang Song
Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Jianchao Luo
Department of Oncology, The Henan Provincial People`s Hospital, Zhengzhou, China
Yanhui Cui
Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China
Zhenhe Jia
Department of Oncology, The Xixia County People`s Hospital, xixia, China
Xiangyu Song
Department of Radiation Oncology, The Linzhou People`s Hospital, Linzhou, China
Hongqi Wang
Department of Radiation Oncology, General Hospital of Pingmei Shenma Medical Group Pingdingshan 467000, Pingmei, China
Xuefeng Qi
Department of Radiation Oncology, The Linying County People`s Hospital, Linying, China
Jinshan Ren
Department of Radiation Oncology, The First Affiliated Hospital of Nanyang Medical College, Nanyang, China
Jixing Cai
Department of Radiation oncology, the Linzhou Cancer Hospital, 456550, P.R, Linzhou, People`s Republic of China
Xainying Fang
Department of Oncology, The Xinyang Central Hospital, Xinyang, China
Mikhail Y Sinelnikov
Department of Human Anatomy, Sechenov University, Moskva, Moskva, Russian Federation
Vladimir N Nikolenko
Department of Human Anatomy, Sechenov University, Moskva, Moskva, Russian Federation
M V Greeshma
Center of Excellence in Molecular Biology and Regenerative Medicine (CEMR), Department of Biochemistry, JSS Academy of Higher Education and Research (JSS AHER), JSS Medical College, Mysuru, Karnataka, India
Ruitai Fan
Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Introduction 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.Methods and analysis 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.Ethics and dissemination This study was approved by the Institutional Ethics Committee of The First Hospital Affiliated of Zhengzhou University (approval number: SS-2018–04).Trial registration 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.
