Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial
单位：[1]Department of Gastrointestinal Surgery, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, China大连医科大学附属第一医院[2]Department of General Surgery, Chinese People’s Liberation Army General Hospital, Beijing 100853, China[3]Department of Abdominal Surgery, Zhejiang Cancer Hospital, Hangzhou 310022, China浙江省肿瘤医院[4]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Center of Gastrointestinal Surgery, Peking University Cancer Hospital & Institute, Beijing 100142, China[5]Department of General Surgery, Peking University First Hospital, Beijing 100034, China[6]Department of Gastrointestinal Surgery, Peking University People’s Hospital, Beijing 100044, China[7]Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China临床科室国家中心普外分中心普外五科（综合普外科）首都医科大学附属北京友谊医院[8]Department of General Surgery, Beijing Hospital, Beijing 100730, China[9]Department of General Surgery, Xuanwu Hospital Capital Medical University, Beijing 100053, China首都医科大学宣武医院[10]Department of General Surgery, Qilu Hospital of Shandong University, Jinan 250012, China[11]Department of General Surgery, Nanjing General Hospital, Nanjing 210002, China[12]Department of Gastrointestinal Surgery, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China[13]Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan 430071, China[14]Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China浙江省肿瘤医院[15]Department of Medical Oncology, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, China大连医科大学附属第一医院[16]Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan 250012, China
Background: The ACTS-GC study had shown postoperative adjuvant 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-1 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.
基金：
National Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81374016, 81402308]; Beijing Municipal Science & Technology CommissionBeijing Municipal Science & Technology Commission [D141100000414002]
第一作者单位：[1]Department of Gastrointestinal Surgery, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, China
共同第一作者：
通讯作者：
通讯机构：[4]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Center of Gastrointestinal Surgery, Peking University Cancer Hospital & Institute, Beijing 100142, China[*1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Center of Gastrointestinal Surgery, Peking University Cancer Hospital & Institute, Beijing 100142, China.
推荐引用方式(GB/T 7714)：
Xiang Hu,Lin Chen,Yian Du,et al.Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial[J].CHINESE JOURNAL of CANCER RESEARCH.2017,29(2):144-148.doi:10.21147/j.issn.1000-9604.2017.02.07.
APA：
Xiang Hu,Lin Chen,Yian Du,Biao Fan,Zhaode Bu...&Jiafu Ji.(2017).Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial.CHINESE JOURNAL of CANCER RESEARCH,29,(2)
MLA：
Xiang Hu,et al."Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial".CHINESE JOURNAL of CANCER RESEARCH 29..2(2017):144-148
