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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
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 conse...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9039379/ https://www.ncbi.nlm.nih.gov/pubmed/35470188 http://dx.doi.org/10.1136/bmjopen-2021-055273 |
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author | Liu, Yun Beeraka, Narasimha M Liu, Junqi Chen, Kuo Song, Bo Song, Zhang Luo, Jianchao Liu, Yang Zheng, Anping Cui, Yanhui Wang, Yang Jia, Zhenhe Song, Xiangyu Wang, Xiaohong Wang, Hongqi Qi, Xuefeng Ren, Jinshan Wu, Liping Cai, Jixing Fang, Xainying Wang, Xin Sinelnikov, Mikhail Y Nikolenko, Vladimir N Greeshma, M V Fan, Ruitai |
author_facet | Liu, Yun Beeraka, Narasimha M Liu, Junqi Chen, Kuo Song, Bo Song, Zhang Luo, Jianchao Liu, Yang Zheng, Anping Cui, Yanhui Wang, Yang Jia, Zhenhe Song, Xiangyu Wang, Xiaohong Wang, Hongqi Qi, Xuefeng Ren, Jinshan Wu, Liping Cai, Jixing Fang, Xainying Wang, Xin Sinelnikov, Mikhail Y Nikolenko, Vladimir N Greeshma, M V Fan, Ruitai |
author_sort | Liu, Yun |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9039379 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-90393792022-05-06 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 Liu, Yun Beeraka, Narasimha M Liu, Junqi Chen, Kuo Song, Bo Song, Zhang Luo, Jianchao Liu, Yang Zheng, Anping Cui, Yanhui Wang, Yang Jia, Zhenhe Song, Xiangyu Wang, Xiaohong Wang, Hongqi Qi, Xuefeng Ren, Jinshan Wu, Liping Cai, Jixing Fang, Xainying Wang, Xin Sinelnikov, Mikhail Y Nikolenko, Vladimir N Greeshma, M V Fan, Ruitai BMJ Open Oncology 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. BMJ Publishing Group 2022-04-25 /pmc/articles/PMC9039379/ /pubmed/35470188 http://dx.doi.org/10.1136/bmjopen-2021-055273 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Oncology Liu, Yun Beeraka, Narasimha M Liu, Junqi Chen, Kuo Song, Bo Song, Zhang Luo, Jianchao Liu, Yang Zheng, Anping Cui, Yanhui Wang, Yang Jia, Zhenhe Song, Xiangyu Wang, Xiaohong Wang, Hongqi Qi, Xuefeng Ren, Jinshan Wu, Liping Cai, Jixing Fang, Xainying Wang, Xin Sinelnikov, Mikhail Y Nikolenko, Vladimir N Greeshma, M V Fan, Ruitai 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9039379/ https://www.ncbi.nlm.nih.gov/pubmed/35470188 http://dx.doi.org/10.1136/bmjopen-2021-055273 |
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