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

Yun Liu; Narasimha M Beeraka; Junqi Liu; Kuo Chen; Bo Song; Zhang Song; Jianchao Luo; Yang Liu; Anping Zheng; Yanhui Cui; Yang Wang; Zhenhe Jia; Xiangyu Song; Xiaohong Wang; Hongqi Wang; Xuefeng Qi; Jinshan Ren; Liping Wu; Jixing Cai; Xainying Fang; Xin Wang; Mikhail Y Sinelnikov; Vladimir N Nikolenko; M V Greeshma; Ruitai Fan

doi:10.1136/bmjopen-2021-055273

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

BMJ Open. 2022 Apr 25;12(4):e055273. doi: 10.1136/bmjopen-2021-055273.

Authors

Yun Liu^#^{1

2}, Narasimha M Beeraka^#^{1

3

4}, Junqi Liu¹, Kuo Chen¹, Bo Song⁵, Zhang Song¹, Jianchao Luo⁶, Yang Liu⁷, Anping Zheng⁸, Yanhui Cui⁹, Yang Wang¹⁰, Zhenhe Jia¹¹, Xiangyu Song¹², Xiaohong Wang¹³, Hongqi Wang¹⁴, Xuefeng Qi¹⁵, Jinshan Ren¹⁶, Liping Wu¹⁷, Jixing Cai¹⁸, Xainying Fang⁵, Xin Wang¹, Mikhail Y Sinelnikov³, Vladimir N Nikolenko^{3

19}, M V Greeshma⁴, Ruitai Fan²⁰

Affiliations

¹ Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
² 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.
³ Department of Human Anatomy, Sechenov University, Moskva, Moskva, Russian Federation.
⁴ 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.
⁵ Department of Oncology, The Xinyang Central Hospital, Xinyang, China.
⁶ Department of Oncology, The Henan Provincial People's Hospital, Zhengzhou, China.
⁷ Department of Radiation Oncology, The Affiliated Tumor Hospital of Zhengzhou University, Zhengzhou, China.
⁸ Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China.
⁹ Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.
¹⁰ Department of Radiation Oncology, The Nanyang Central Hospital, Nanyang, China.
¹¹ Department of Oncology, The Xixia County People's Hospital, xixia, China.
¹² Department of Radiation Oncology, The Linzhou People's Hospital, Linzhou, China.
¹³ Department of Radiation Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
¹⁴ Department of Radiation Oncology, General Hospital of Pingmei Shenma Medical Group Pingdingshan 467000, Pingmei, China.
¹⁵ Department of Radiation Oncology, The Linying County People's Hospital, Linying, China.
¹⁶ Department of Radiation Oncology, The First Affiliated Hospital of Nanyang Medical College, Nanyang, China.
¹⁷ Department of Radiation Oncology, The Xinxiang Central Hospital, Xinxiang, China.
¹⁸ Department of Radiation oncology, the Linzhou Cancer Hospital, 456550, P.R, Linzhou, People's Republic of China.
¹⁹ Department of Human anatomy, M.V. Lomonosov Moscow State University, Moscow, Russian Federation.
²⁰ Cancer Center, Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China fccfanrt@zzu.edu.cn.

^# Contributed equally.

Abstract

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.

Keywords: ONCOLOGY; RADIOTHERAPY; Respiratory tract tumours.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Chemoradiotherapy / methods
Esophageal Neoplasms* / therapy
Esophageal Squamous Cell Carcinoma* / therapy
Humans
Organoplatinum Compounds / therapeutic use

Substances

Organoplatinum Compounds
nedaplatin