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

被引：8

作者：

Hu, Xiang ^{[1
]}

Chen, Lin ^{[2
]}

Du, Yian ^{[3
]}

Fan, Biao ^{[4
]}

Bu, Zhaode ^{[4
]}

Wang, Xin ^{[5
]}

Ye, Yingjiang ^{[6
]}

Zhang, Zhongtao ^{[7
]}

Xiao, Gang ^{[8
]}

Li, Fei ^{[9
]}

He, Qingsi ^{[10
]}

Li, Guoli ^{[11
]}

Shen, Xian ^{[12
]}

Xiong, Bin ^{[13
]}

Zhu, Liming ^{[14
]}

Liu, Jiwei ^{[15
]}

Liu, Lian ^{[16
]}

Wu, Tao ^{[5
]}

Zhou, Jing ^{[6
]}

Zhang, Jun ^{[7
]}

Zhao, Gang ^{[8
]}

Wang, Xulin ^{[11
]}

Liang, Pin ^{[1
]}

Wang, Xinxin ^{[2
]}

Zhang, Yan ^{[9
]}

Wu, Xiaojiang ^{[4
]}

Zhang, Ji ^{[4
]}

Ji, Xin ^{[4
]}

Zong, Xianglong ^{[4
]}

Fu, Tao ^{[4
]}

Jia, Ziyu ^{[4
]}

Ji, Jiafu ^{[4
]}

机构：

[1] Dalian Med Univ, Affiliated Hosp 1, Dept Gastrointestinal Surg, Dalian 116011, Peoples R China

[2] Chinese Peoples Liberat Army Gen Hosp, Dept Gen Surg, Beijing 100853, Peoples R China

[3] Zhejiang Canc Hosp, Dept Abdominal Surg, Hangzhou 310022, Zhejiang, Peoples R China

[4] Peking Univ, Canc Hosp & Inst, Key Lab Carcinogenesis & Translat Res, Minist Educ Beijing,Ctr Gastrointestinal Surg, Beijing 100142, Peoples R China

[5] Peking Univ, Hosp 1, Dept Gen Surg, Beijing 100034, Peoples R China

[6] Peking Univ, Peoples Hosp, Dept Gastrointestinal Surg, Beijing 100044, Peoples R China

[7] Capital Med Univ, Beijing Friendship Hosp, Dept Gen Surg, Beijing 100050, Peoples R China

[8] Beijing Hosp, Dept Gen Surg, Beijing 100730, Peoples R China

[9] Capital Med Univ, Xuanwu Hosp, Dept Gen Surg, Beijing 100053, Peoples R China

[10] Shandong Univ, Qilu Hosp, Dept Gen Surg, Jinan 250012, Peoples R China

[11] Nanjing Gen Hosp, Dept Gen Surg, Nanjing 210002, Jiangsu, Peoples R China

[12] Wenzhou Med Univ, Affiliated Hosp 1, Dept Gastrointestinal Surg, Wenzhou 325000, Peoples R China

[13] Wuhan Univ, Zhongnan Hosp, Dept Oncol, Wuhan 430071, Peoples R China

[14] Zhejiang Canc Hosp, Dept Med Oncol, Hangzhou 310022, Zhejiang, Peoples R China

[15] Dalian Med Univ, Affiliated Hosp 1, Dept Med Oncol, Dalian 116011, Peoples R China

[16] Shandong Univ, Qilu Hosp, Dept Chemotherapy, Jinan 250012, Peoples R China

来源：

CHINESE JOURNAL OF CANCER RESEARCH | 2017年 / 29卷 / 02期

基金：

美国国家科学基金会;

关键词：

Locally advanced gastric cancer; S-1 plus oxaliplatin; randomized phase III trial; ADJUVANT CHEMOTHERAPY; SURGERY; TEGAFUR;

D O I：

10.21147/j.issn.1000-9604.2017.02.07

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

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.

引用

页码：144 / 148

页数：5

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