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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2017-020785 on 21 October 2018. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 26, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020785 on 21 October 2018. Downloaded from Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced esophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2) For peer review only Journal: BMJ Open Manuscript ID bmjopen-2017-020785 Article Type: Protocol Date Submitted by the Author: 23-Nov-2017 Complete List of Authors: Ai, Dashan; Fudan University Shanghai Cancer Center, Department of Radiation Oncology; Shanghai Medical College, Fudan University, Department of Oncology Chen, Yun; Fudan University Shanghai Cancer Center, Department of Radiation Oncology; Shanghai Medical College, Fudan University, Department of Oncology Liu, Qi; Fudan University Shanghai Cancer Center, Department of Radiation Oncology; Shanghai Medical College, Fudan University, Department of Oncology Zhang, Junhua; Fudan University Shanghai Cancer Center, Department of Radiation Oncology; Shanghai Medical College, Fudan University, http://bmjopen.bmj.com/ Department of Oncology Deng, Jiaying; Fudan University Shanghai Cancer Center, Department of Radiation Oncology; Shanghai Medical College, Fudan University, Department of Oncology Zhu, Hanting; Fudan University Shanghai Cancer Center, Department of Radiation Oncology; Shanghai Medical College, Fudan University, Department of Oncology Ren, Wenjia; Fudan University Shanghai Cancer Center, Department of Radiation Oncology; Shanghai Medical College, Fudan University, on September 26, 2021 by guest. Protected copyright. Department of Oncology Zheng, Xiangpeng; Huadong Hospital Affiliated to Fudan University, Department of Radiation Oncology Li, Yunhai; Fudan University Shanghai Cancer Center Minhang Branch Hospital, Department of Radiation Oncology Wei, Shihong; Gansu Province Cancer Hospital, Department of Radiation Oncology Ye, Jinjun; Jiangsu Cancer Hospital, Department of Radiation Oncology Zhou, Jialiang; Affiliated Hospital of Jiangnan University, Department of Radiation Oncology Lin, Qin; First Affiliated Hospital of Xiamen University, Department of Radiation Oncology Luo, Hui; Jiangxi Province Cancer Hospital, Department of Radiation Oncology Cao, Jianzhong; Shanxi Province Cancer Hospital, Department of Radiation Oncology Li, Jiancheng; Fujian Province Cancer Hospital, Department of Radiation For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 17 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020785 on 21 October 2018. Downloaded from 1 2 3 4 Oncology Huang, Guang; Hainan Province People’s Hospital, Department of Radiation 5 Oncology 6 Wu, Kailiang; Fudan University Shanghai Cancer Center, Department of 7 Radiation Oncology; Shanghai Medical College, Fudan University, 8 Department of Oncology 9 Fan, Min; Fudan University Shanghai Cancer Center, Department of 10 Radiation Oncology; Shanghai Medical College, Fudan University, Department of Oncology 11 Yang, Huanjun; Fudan University Shanghai Cancer Center, Department of 12 Radiation Oncology; Shanghai Medical College, Fudan University, 13 Department of Oncology 14 Zhu, Zhengfei; Fudan University Shanghai Cancer Center, Department of 15 Radiation Oncology; Shanghai Medical College, Fudan University, 16 Department of Oncology For peerZhao, Weixin; reviewFudan University Shanghai only Cancer Center, Department of 17 Radiation Oncology; Shanghai Medical College, Fudan University, 18 Department of Oncology 19 Li, Ling; Fudan University Shanghai Cancer Center, Department of 20 Radiation Oncology; Shanghai Medical College, Fudan University, 21 Department of Oncology 22 Fan, Jianhong; Renhe Hospital, Department of Gynecology Badakhshi, Harun; Charite´ School of Medicine and Centre for Cancer 23 Medicine, Department of Radiation Oncology 24 Zhao, Kuaile; Fudan University Shanghai Cancer Center, Department of 25 Radiation Oncology; Shanghai Medical College, Fudan University, 26 Department of Oncology 27 esophageal squamous cell carcinoma, concurrent chemoradiotherapy, 28 Keywords: paclitaxel, cisplatin, carboplatin, fluorouracil 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 26, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 17 BMJ Open: first published as 10.1136/bmjopen-2017-020785 on 21 October 2018. Downloaded from 1 2 3 Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or 4 5 fluorouracil (TF) concurrent with radiotherapy for patients with local advanced 6 esophageal squamous cell carcinoma: a three-arm phase III randomized trial 7 8 (ESO-Shanghai 2) 9 1, 2 1, 2 1, 2 1, 2 1, 2 10 Dashan Ai , Yun Chen , Qi Liu , Junhua Zhang , Jiaying Deng , Hanting 11 Zhu1, 2, Wenjia Ren1, 2, Xiangpeng Zheng3, Yunhai Li4, Shihong Wei5, Jinjun Ye6, 12 13 Jialiang Zhou7, Qin Lin8, Hui Luo9, Jianzhong Cao10, Jiancheng Li11, Guang Huang12, 14 1, 2 1, 2 1, 2 1, 2 1, 2 15 Kailiang Wu , Min Fan , Huanjun Yang , Zhengfei Zhu , Weixin Zhao , Ling 16 Li1, 2, JianhongFor Fan13, Harunpeer Badakhshi review14, Kuaile Zhao1, only2 17 18 1. Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 19 20 Shanghai, China 21 2. Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 22 23 China 24 25 3. Department of Radiation Oncology, Huadong Hospital Affiliated to Fudan 26 University, Shanghai, China 27 28 4. Department of Radiation Oncology, Fudan University Shanghai Cancer Center 29 30 Minhang Branch Hospital, Shanghai, China 31 5. Department of Radiation Oncology, Gansu Province Cancer Hospital, Lanzhou, 32 33 China http://bmjopen.bmj.com/ 34 35 6. Department of Radiation Oncology, Jiangsu Province Cancer Hospital, Nanjing, 36 China 37 38 7. Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, 39 40 Wuxi, China 41 8. Department of Radiation Oncology, First Affiliated Hospital of Xiamen University, on September 26, 2021 by guest. Protected copyright. 42 43 Xiamen, China 44 45 9. Department of Radiation Oncology, Jiangxi Province Cancer Hospital, Nanchang, 46 China 47 48 10. Department of Radiation Oncology, Shanxi Province Cancer Hospital, Taiyuan, 49 50 China 51 11. Department of Thoracic Radiation Oncology, Fujian Province Cancer Hospital, 52 53 Fuzhou, China 54 12. Department of Radiation Oncology, Hainan Province People’s Hospital, Haikou, 55 56 China 57 58 1 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 17 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020785 on 21 October 2018. Downloaded from 1 2 3 13. Department of Gynecology, Renhe hospital, Shanghai, China 4 5 14. Department of Radiation Oncology, Charite´ School of Medicine and Centre for 6 Cancer Medicine, Berlin, Germany 7 8 Corresponding author: Kuaile Zhao, 270 Dongan Rd, Shanghai, 200032, China. Email: 9 10 [email protected]. Tel: +86-21-64175590 11 Key words: esophageal squamous cell carcinoma, concurrent chemoradiotherapy, 12 13 paclitaxel, cisplatin, carboplatin, fluorouracil 14 15 Word counts: 2,316 words 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 26, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 17 BMJ Open: first published as 10.1136/bmjopen-2017-020785 on 21 October 2018. Downloaded from 1 2 3 Abstract 4 5 Introduction: Concurrent chemoradiation is the standard therapy for patients with 6 local advanced esophageal carcinoma unsuitable for surgery. Paclitaxel is an active 7 8 agent against esophageal cancer and it has been proved as a potent radiation sensitizer. 9 10 There have been multiple studies evaluating paclitaxel-based chemoradiation in 11 esophageal cancer, the results of which are inspiring. However, which regimen, 12 13 among paclitaxel in combination with cisplatin (TP), carboplatin (TC) and 14 15 fluorouracil (TF) concurrent with radiotherapy, provides best prognosis with 16 minimum adverseFor events peer is still considered review far from resolved only and very few studies 17 18
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