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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

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收录情况: ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C

机构: [1]Department of Gastrointestinal Surgery, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, China [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 [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 [8]Department of General Surgery, Beijing Hospital, Beijing 100730, China [9]Department of General Surgery, Xuanwu Hospital Capital Medical University, Beijing 100053, China [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 [15]Department of Medical Oncology, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, China [16]Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan 250012, China
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关键词: Locally advanced gastric cancer S-1 plus oxaliplatin randomized phase III trial

摘要:
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.

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出版当年[2016]版:
大类 | 4 区 医学
小类 | 4 区 肿瘤学
最新[2023]版:
大类 | 2 区 医学
小类 | 3 区 肿瘤学
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出版当年[2015]版:
Q3 ONCOLOGY
最新[2023]版:
Q1 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2015版] 出版当年五年平均 出版前一年[2014版] 出版后一年[2016版]

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第一作者机构: [1]Department of Gastrointestinal Surgery, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, China
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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
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