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Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1alone in locally advanced gastric cancer(RESCUE-GC study): a protocol for a phase Ⅲ randomized controlled trial

引用

Chinese Journal of Cancer Research 2017年第2期29卷 144-148页

作者： Xiang Hu Lin Chen Yian Du Biao Fan Zhaode Bu Xin Wang Yingjiang Ye Zhongtao Zhang Gang Xiao Fei Li Qingsi He Guoli Li Xian Shen Bin Xiong Liming Zhu Jiwei Liui Lian Liu Tao Wu Jing Zhou Jun Zhang Gang Zhao Xulin Wang Pin Liang Xinxin Wang Yan Zhang Xiaojiang Wu Ji Zhang Xin Ji Xianglong Zong Tao Fu Ziyu Jia Jiafu Ji Department of Gastrointestinal Surgery the First Affiliated Hospital of Dalian Medical University Dalian 116011 China Deparunent of General Surgery Chinese People's Liberation Army General Hospital Beijing 100853 China Department of Abdominal Surgery Zhejiang Cancer Hospital Hangzhou 310022 China Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing) Center of Gastrointestinal Surgery Peking University Cancer Hospital & Institute Beijing 100142 China Department of General Surgery Peking University First Hospital Beijing 100034 China Department of Gastrointestinal Surgery Peking University People's Hospital Beijing 100044 China Department of General Surgery Beijing Friendship Hospital Capital Medical University Beijing 100050 China Department of General Surgery Beijing Hospital Beijing 100730 China Department of General Surgery Xuanwu Hospital Capital Medical University Beijing 100053 China Department of General Surgery Qilu Hospital of Shandong University Jinan 250012 China Department of General Surgery Nanjing General Hospital Nanjing 210002 China Department of Gastrointestinal Surgery the First Affiliated Hospital of Wenzhou Medical University Wenzhou 325000 China Department of Oncology Zhongnan Hospital of Wuhan University Wuhan 430071 China Department of Medical Oncology Zhejiang Cancer Hospital Hangzhou 310022 China Department of Medical Oncology the First Affiliated Hospital of Dalian Medical University Dalian 116011 China Department of Chemotherapy Qilu Hospital of Shandong University Jinan 250012 China

Background： The ACTS-GC study had shown postoperative adiuvant therapy with S-1 improved survival of patients with locally advanced gastric cancer. Addition of oxaliplatin to S-1 is considered to be acceptable as one of the treatment options for gastric cancer patients after radical gastrectomy with D2 lymph node excision. Methods： We have commenced a randomized phase III trial in December 2016 to evaluate S-I plus oxaliplatin compared with S-1 alone in the adjuvant setting for locally advanced gastric cancer. A total of 564 patients will be accrued from 13 Chinese institutions in two years. The primary endpoint is 3-year relapse-free survival. The secondary endpoints are 5-year overall survival, proportion of patients who complete the postoperative chemotherapy and incidence of adverse events. Ethic and dissemination： The trial has been approved by the institutional review board of each participating institution and it was activated on December, 2016. The enrollment will be finished in December, 2018. Patient＇s follow-up will be ended until December, 2023. trial registration： ***, identifier： NCT02867839. Registered on August 4, 2016.

关键词： Locally advanced gastric cancer S-1 plus oxaliplatin randomized phase hi trial

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