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

被引：30

作者：

Wang, Xinxin ^{[1
,2
]}

Li, Shuo ^{[1
,2
]}

Sun, Yihong ^{[3
]}

Li, Kai ^{[4
]}

Shen, Xian ^{[5
]}

Xue, Yingwei ^{[6
]}

Liang, Pin ^{[7
]}

Li, Guoli ^{[8
]}

Chen, Luchuan ^{[9
]}

Zhao, Qun ^{[10
]}

Li, Guoxin ^{[11
]}

Fu, Weihua ^{[12
]}

Liang, Han ^{[13
]}

Xin, Hairong ^{[14
]}

Suo, Jian ^{[15
]}

Fang, Xuedong ^{[16
]}

Zheng, Zhichao ^{[17
]}

Xu, Zekuan ^{[18
]}

Chen, Huanqiu ^{[19
]}

Zhou, Yanbing ^{[20
]}

He, Yulong ^{[21
]}

Huang, Hua ^{[22
]}

Zhu, Linghua ^{[23
]}

Yang, Kun ^{[24
]}

Ji, Jiafu ^{[25
]}

Ye, Yingjiang ^{[26
]}

Zhang, Zhongtao ^{[27
]}

Li, Fei ^{[28
]}

Wang, Xin ^{[29
]}

Tian, Yantao ^{[30
]}

Park, Sungsoo ^{[31
]}

Chen, Lin ^{[1
,2
]}

机构：

[1] Chinese Peoples Liberat Army Gen Hosp, Dept Gen Surg, 28 Fuxing Rd, Beijing 100853, Peoples R China

[2] Chinese Peoples Liberat Army Gen Hosp, Inst Gen Surg, 28 Fuxing Rd, Beijing 100853, Peoples R China

[3] Fudan Univ, Zhongshan Hosp, Dept Gen Surg, 180 Fenglin Rd, Shanghai 200032, Peoples R China

[4] China Med Univ, Dept Surg Oncol, Hosp 1, 155 Nanjing St North, Shenyang 110001, Peoples R China

[5] Wenzhou Med Univ, Div Gastrointestinal Surg, Affiliated Hosp 2, 109 West Xueyuan Rd, Wenzhou 325027, Peoples R China

[6] Harbin Med Univ, Dept Gastroenterol Surg, Canc Hosp, 150 Haping Rd, Harbin 150081, Peoples R China

[7] Dalian Med Univ, Dept Gastrointestinal Surg, Affiliated Hosp 1, 222 Zhongshan Rd, Dalian 116011, Peoples R China

[8] Gen Hosp Eastern Theater Command Chinese PLA, Inst Gen Surg, 305 East Zhongshan Rd, Nanjing 210002, Peoples R China

[9] Fujian Med Univ, Fujian Canc Hosp, Dept Gastrointestinal Surg, Canc Hosp, 420 Fuma Rd, Fuzhou 350014, Peoples R China

[10] Hebei Med Univ, Dept Gen Surg, Hosp 4, 12 Jiankang Rd, Shijiazhuang 050011, Hebei, Peoples R China

[11] Southern Med Univ, Nanfang Hosp, Dept Gen Surg, 1838 Guangzhoudadaobei Rd, Guangzhou 510515, Peoples R China

[12] Tianjin Med Univ, Dept Gen Surg, Gen Hosp, 154 Anshan Rd, Tianjin 300052, Peoples R China

[13] Tianjin Med Univ, Dept Gastr Canc Surg, Canc Hosp, West Huan Hu Rd, Tianjin 300060, Peoples R China

[14] Shanxi Prov Canc Hosp, Dept Gen Surg, 3 Zhigongxincun, Taiyuan 030013, Peoples R China

[15] Jilin Univ, Dept Gen Surg, Bethune Hosp 1, 71 Xinmindajie St, Changchun 130021, Peoples R China

[16] Jilin Univ, Dept Gen Surg, China Japan Union Hosp, 126 Xiantai Ave, Changchun 130033, Peoples R China

[17] Liaoning Canc Hosp & Inst, Dept Gastr Surg, 44 Xiaoheyan Rd, Shenyang 110042, Peoples R China

[18] Nanjing Med Univ, Dept Gen Surg, Affiliated Hosp 1, 300 Guangzhou Rd, Nanjing 210029, Peoples R China

[19] Nanjing Med Univ, Jiangsu Canc Hosp, Dept Gen Surg, Jiangsu Inst Canc Res,Affiliated Canc Hosp, 42 Baiziting, Nanjing 210009, Peoples R China

[20] Qingdao Univ, Dept Gen Surg, Affiliated Hosp, 16 Jiangsu Rd, Qingdao 266003, Peoples R China

[21] Sun Yat Sen Univ, Affiliated Hosp 1, Dept Gastrointestinal Surg, 58 Zhongshaner Rd, Guangzhou 510080, Peoples R China

[22] Fudan Univ, Dept Gastr Surg, Shanghai Canc Ctr, 270 Dongan Rd, Shanghai 200032, Peoples R China

[23] Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Gen Surg, 3 East Qingchun Rd, Hangzhou 310016, Peoples R China

[24] Sichuan Univ, West China Hosp, Dept Gastrointestinal Surg, 37 Guoxue Alley, Chengdu 610041, Peoples R China

[25] Peking Univ, Dept Gastrointestinal Surg, Canc Hosp, 52 Fucheng Rd, Beijing 100142, Peoples R China

[26] Peking Univ, Dept Gastroenterol Surg, Peoples Hosp, 11 Xizhimen South St, Beijing 100044, Peoples R China

[27] Capital Med Univ, Beijing Friendship Hosp, Dept Gen Surg, 95 Yongan Rd, Beijing 100050, Peoples R China

[28] Capital Med Univ, Xuanwu Hosp, Dept Gen Surg, 45 Changchun St, Beijing 100053, Peoples R China

[29] Peking Univ, Dept Gen Surg, Hosp 1, 8 Xishiku St, Beijing 100034, Peoples R China

[30] Chinese Acad Med Sci, Canc Hosp, Dept Pancreat & Gastr Surg, 17 Panjiayuannanli, Beijing 100021, Peoples R China

[31] Korea Univ, Coll Med, Dept Surg, Div Upper GI Surg,Anam Hosp, 73 Goryeodae Ro, Seoul 02841, South Korea

来源：

BMC CANCER | 2021年 / 21卷 / 01期

关键词：

Locally advanced gastric cancer; Duration of neoadjuvant chemotherapy; S-1; Oxaliplatin; PERIOPERATIVE CHEMOTHERAPY; D2; GASTRECTOMY; SURGERY;

D O I：

10.1186/s12885-020-07764-7

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

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.

引用

页数：8

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