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

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 Liu; 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

来源：Chinese Journal of Cancer Research, 2017, 29(02): 144-148.

• Locally advanced gastric cancer
• S-1 plus oxaliplatin
• randomized phase III trial

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.Trial registration:Clinical Trials.gov,identifier:NCT02867839.Registered on August 4,2016.

• 单位
  北京大学