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The protocol of a prospective, multicenter, randomized, controlled phase III study evaluating different cycles of oxaliplatin combined with S-1 (SOX) as neoadjuvant chemotherapy for patients with locally advanced gastric cancer: RESONANCE-II trial(Open Access)

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作者：
Xinxin Wang[1] ; Shuo Li[1] ; Yihong Sun[2] ; Kai Li[3] ; Xian Shen[4] ; Yingwei Xue[5] ; Pin Liang[6] ; Guoli Li[7] ; Luchuan Chen[8] ; Qun Zhao[9] ; Guoxin Li[10] ; Weihua Fu[11] ; Han Liang[12] ; Hairong Xin[13] ; Jian Suo[14] ; Xuedong Fang[15] ; Zhichao Zheng[16] ; Zekuan Xu[17] ; Huanqiu Chen[18] ; Yanbing Zhou[19] ; Yulong He[20] ; Hua Huang[21] ; Linghua Zhu[22] ; Kun Yang[23] ; Jiafu Ji[24] ; Yingjiang Ye[25] ; Zhongtao Zhang[26] ; Fei Li[27] ; Xin Wang[28] ; Yantao Tian[29] ; Sungsoo Park[30] ; Lin Chen[1] ;
机构： [1]Department of General Surgery & Institute of General Surgery, Chinese PLAGeneral Hospital, No.28 Fuxing Road, Haidian District, Beijing 100853, China [2]Department of General Surgery, Zhongshan Hospital, Fudan University,No.180 Fenglin Road, Xuhui District, Shanghai 200032, China [3]Department ofSurgical Oncology, The First Hospital of China Medical University, No.155Nanjing Street North, Heping District, Shenyang 110001, China [4]Division ofGastrointestinal Surgery, The Second Affiliated Hospital of Wenzhou MedicalUniversity, No.109 West Xueyuan Road, Wenzhou 325027, China [5]Department of Gastroenterological Surgery, Harbin Medical UniversityCancer Hospital, No.150 Haping Road, Nangang District, Harbin 150081,China [6]Department of Gastrointestinal Surgery, The First Affiliated Hospital ofDalian Medical University, No.222 Zhongshan Road, Xigang District, Dalian116011, China [7]Institute of General Surgery, General Hospital of EasternTheater Command of Chinese PLA, No.305 East Zhongshan Road, XuanwuDistrict, Nanjing 210002, China [8]Department of Gastrointestinal Surgery,Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, No.420Fuma Road, Jinan District, Fuzhou 350014, China [9]Department of GeneralSurgery, The Fourth Hospital of Hebei Medical University, No.12 JiankangRoad, Shijiazhuang 050011, China [10]Department of General Surgery, NanfangHospital, Southern Medical University, No.1838 Guangzhoudadaobei Road,Guangzhou 510515, China [11]Department of General Surgery, Tianjin MedicalUniversity General Hospital, No.154 Anshan Road, Heping District, Tianjin300052, China [12]Department of Gastric Cancer Surgery, Tianjin MedicalUniversity Cancer Hospital, West Huan-Hu Road, Ti Yuan Bei, Hexi District,Tianjin 300060, China [13]Department of General Surgery, Shanxi ProvincialCancer Hospital, No.3 Zhigongxincun, Xinghualing District, Taiyuan 030013,China [14]Department of General Surgery, The First Bethune Hospital of JilinUniversity, No.71 Xinmindajie Street, Changchun 130021, China [15]Department of General Surgery, China-Japan Union Hospital of Jilin University, No.126 Xi’antai Avenue, Changchun 130033, China [16]Departmentof Gastric Surgery, Liaoning Cancer Hospital and Institute, No.44 XiaoheyanRoad, Dadong District, Shenyang 110042, China [17]Department of GeneralSurgery, The First Affiliated Hospital of Nanjing Medical University, No.300Guangzhou Road, Gulou District, Nanjing 210029, China [18]Department ofGeneral Surgery, Jiangsu Cancer Hospital (Jiangsu Institute of CancerResearch, Nanjing Medical University Affiliated Cancer Hospital), No.42Baiziting, Nanjing 210009, China [19]Department of General Surgery, TheAffiliated Hospital of Qingdao University, No.16 Jiangsu Road, Shinan District,Qingdao 266003, China [20]Department of Gastrointestinal Surgery, The FirstAffiliated Hospital, Sun Yat-sen University, No.58 Zhongshaner Road,Guangzhou 510080, China [21]Department of Gastric Surgery, Fudan UniversityShanghai Cancer Center, No.270 Dongan Road, Xuhui District, Shanghai200032, China [22]Department of General Surgery, Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University, No.3 East Qingchun Road, JiangganDistrict, Hangzhou 310016, China [23]Department of Gastrointestinal Surgery,West China Hospital, Sichuan University, No.37 Guoxue Alley, Wuhou District,Chengdu 610041, China [24]Department of Gastrointestinal Surgery, PekingUniversity Cancer Hospital, No.52 Fucheng Road, Haidian District, Beijing100142, China [25]Department of Gastroenterological Surgery, PekingUniversity People’s Hospital, No.11 Xizhimen South Street, Xicheng District,Beijing 100044, China [26]Department of General Surgery, Beijing FriendshipHospital, Capital Medical University, No.95 Yongan Road, Xicheng District,Beijing 100050, China [27]Department of General Surgery, Xuanwu Hospital,Capital Medical University, No.45 Changchun Street, Xicheng District, Beijing100053, China [28]Department of General Surgery, Peking University FirstHospital, No.8 Xishiku Street, Xicheng District, Beijing 100034, China [29]Department of Pancreatic and Gastric Surgery, Cancer Hospital, ChineseAcademy of Medical Sciences, No.17 Panjiayuannanli, Chaoyang District,Beijing 100021, China [30]Division of Upper GI Surgery, Department of Surgery,Korea University Anam Hospital, Korea University College of Medicine, 73Goryeodae-ro Seongbuk-gu, Seoul 02841, South Korea.
出处：
DOI： 10.1186/s12885-020-07764-7
ISSN：

关键词： Duration of neoadjuvant chemotherapy Locally advanced gastric cancer Oxaliplatin S-1

摘要：
Background: Curing locally advanced gastric cancer through surgery alone is difficult. Adjuvant and neoadjuvant chemotherapy bring potential benefits to more patients with gastric cancer based on several clinical trials. According to phase II studies and guidelines, SOX regimen as neoadjuvant chemotherapy is efficient. However, the optimal duration of neoadjuvant chemotherapy has not been established. In this study, we will evaluate the efficacy and safety of different cycles of SOX as neoadjuvant chemotherapy for patients with locally advanced gastric cancer. Methods: RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which will enroll 524 patients in total. Eligible patients will be registered, pre-enrolled and receive three cycles of SOX, after which tumor response evaluations will be carried out. Those who show stable disease or progressive disease will be excluded. Patients showing complete response or partial response will be enrolled and assigned into either group A for another three cycles of SOX (six cycles in total) followed by D2 surgery; or group B for D2 surgery (three cycles in total). The primary endpoint is the rate of pathological complete response and the secondary endpoints are R0 resection rate, three-year disease-free survival, five-year overall survival, and safety. Discussion: This study is the first phase III randomized trial to compare the cycles of neoadjuvant chemotherapy using SOX for resectable locally advanced cancer. Based on a total of six to eight cycles of perioperative chemotherapy usually applied in locally advanced gastric cancer, patients in group A can be considered to have completed all perioperative chemotherapy, the results of which may suggest the feasibility of using chemotherapy only before surgery in gastric cancer. Trial registration: Registered prospectively in the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) with registration number ChiCTR1900023293 on May 21st, 2019. © 2021, The Author(s).

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出版当年[2021]版：
大类 | 2 区 医学
小类 | 3 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[2021]版：
Q2 ONCOLOGY
最新[2023]版：
Q2 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]Department of General Surgery & Institute of General Surgery, Chinese PLAGeneral Hospital, No.28 Fuxing Road, Haidian District, Beijing 100853, China
通讯作者：
推荐引用方式(GB/T 7714)：
Xinxin Wang,Shuo Li,Yihong Sun,et al.The protocol of a prospective, multicenter, randomized, controlled phase III study evaluating different cycles of oxaliplatin combined with S-1 (SOX) as neoadjuvant chemotherapy for patients with locally advanced gastric cancer: RESONANCE-II trial(Open Access)[J].BMC Cancer.2021,21(1):20.doi:10.1186/s12885-020-07764-7.
APA：
Xinxin Wang,Shuo Li,Yihong Sun,Kai Li,Xian Shen...&Lin Chen.(2021).The protocol of a prospective, multicenter, randomized, controlled phase III study evaluating different cycles of oxaliplatin combined with S-1 (SOX) as neoadjuvant chemotherapy for patients with locally advanced gastric cancer: RESONANCE-II trial(Open Access).BMC Cancer,21,(1)
MLA：
Xinxin Wang,et al."The protocol of a prospective, multicenter, randomized, controlled phase III study evaluating different cycles of oxaliplatin combined with S-1 (SOX) as neoadjuvant chemotherapy for patients with locally advanced gastric cancer: RESONANCE-II trial(Open Access)".BMC Cancer 21..1(2021):20

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