. 2021 Jan 5;21(1):20.

doi: 10.1186/s12885-020-07764-7.

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

Xinxin Wang¹, Shuo Li¹, Yihong Sun², Kai Li³, Xian Shen⁴, Yingwei Xue⁵, Pin Liang⁶, Guoli Li⁷, Luchuan Chen⁸, Qun Zhao⁹, Guoxin Li¹⁰, Weihua Fu¹¹, Han Liang¹², Hairong Xin¹³, Jian Suo¹⁴, Xuedong Fang¹⁵, Zhichao Zheng¹⁶, Zekuan Xu¹⁷, Huanqiu Chen¹⁸, Yanbing Zhou¹⁹, Yulong He²⁰, Hua Huang²¹, Linghua Zhu²², Kun Yang²³, Jiafu Ji²⁴, Yingjiang Ye²⁵, Zhongtao Zhang²⁶, Fei Li²⁷, Xin Wang²⁸, Yantao Tian²⁹, Sungsoo Park³⁰, Lin Chen³¹

Affiliations

¹ Department of General Surgery & Institute of General Surgery, Chinese PLA General 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 of Surgical Oncology, The First Hospital of China Medical University, No.155 Nanjing Street North, Heping District, Shenyang, 110001, China.
⁴ Division of Gastrointestinal Surgery, The Second Affiliated Hospital of Wenzhou Medical University, No.109 West Xueyuan Road, Wenzhou, 325027, China.
⁵ Department of Gastroenterological Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Nangang District, Harbin, 150081, China.
⁶ Department of Gastrointestinal Surgery, The First Affiliated Hospital of Dalian Medical University, No.222 Zhongshan Road, Xigang District, Dalian, 116011, China.
⁷ Institute of General Surgery, General Hospital of Eastern Theater Command of Chinese PLA, No.305 East Zhongshan Road, Xuanwu District, Nanjing, 210002, China.
⁸ Department of Gastrointestinal Surgery, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, No.420 Fuma Road, Jinan District, Fuzhou, 350014, China.
⁹ Department of General Surgery, The Fourth Hospital of Hebei Medical University, No.12 Jiankang Road, Shijiazhuang, 050011, China.
¹⁰ Department of General Surgery, Nanfang Hospital, Southern Medical University, No.1838 Guangzhoudadaobei Road, Guangzhou, 510515, China.
¹¹ Department of General Surgery, Tianjin Medical University General Hospital, No.154 Anshan Road, Heping District, Tianjin, 300052, China.
¹² Department of Gastric Cancer Surgery, Tianjin Medical University Cancer Hospital, West Huan-Hu Road, Ti Yuan Bei, Hexi District, Tianjin, 300060, China.
¹³ Department of General Surgery, Shanxi Provincial Cancer Hospital, No.3 Zhigongxincun, Xinghualing District, Taiyuan, 030013, China.
¹⁴ Department of General Surgery, The First Bethune Hospital of Jilin University, 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 Department of Gastric Surgery, Liaoning Cancer Hospital and Institute, No.44 Xiaoheyan Road, Dadong District, Shenyang, 110042, China.
¹⁷ Department of General Surgery, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Gulou District, Nanjing, 210029, China.
¹⁸ Department of General Surgery, Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital), No.42 Baiziting, Nanjing, 210009, China.
¹⁹ Department of General Surgery, The Affiliated Hospital of Qingdao University, No.16 Jiangsu Road, Shinan District, Qingdao, 266003, China.
²⁰ Department of Gastrointestinal Surgery, The First Affiliated Hospital, Sun Yat-sen University, No.58 Zhongshaner Road, Guangzhou, 510080, China.
²¹ Department of Gastric Surgery, Fudan University Shanghai Cancer Center, No.270 Dongan Road, Xuhui District, Shanghai, 200032, China.
²² Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No.3 East Qingchun Road, Jianggan District, 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, Peking University Cancer Hospital, No.52 Fucheng Road, Haidian District, Beijing, 100142, China.
²⁵ Department of Gastroenterological Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
²⁶ Department of General Surgery, Beijing Friendship Hospital, 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, Beijing, 100053, China.
²⁸ Department of General Surgery, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, 100034, China.
²⁹ Department of Pancreatic and Gastric Surgery, Cancer Hospital, Chinese Academy 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, 73 Goryeodae-ro Seongbuk-gu, Seoul, 02841, South Korea.
³¹ Department of General Surgery & Institute of General Surgery, Chinese PLA General Hospital, No.28 Fuxing Road, Haidian District, Beijing, 100853, China. chenlinbj@yeah.net.

PMID: 33402102
PMCID: PMC7786891
DOI: 10.1186/s12885-020-07764-7

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

Xinxin Wang et al. BMC Cancer. 2021.

. 2021 Jan 5;21(1):20.

doi: 10.1186/s12885-020-07764-7.

Authors

Affiliations

¹ Department of General Surgery & Institute of General Surgery, Chinese PLA General 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 of Surgical Oncology, The First Hospital of China Medical University, No.155 Nanjing Street North, Heping District, Shenyang, 110001, China.
⁴ Division of Gastrointestinal Surgery, The Second Affiliated Hospital of Wenzhou Medical University, No.109 West Xueyuan Road, Wenzhou, 325027, China.
⁵ Department of Gastroenterological Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Nangang District, Harbin, 150081, China.
⁶ Department of Gastrointestinal Surgery, The First Affiliated Hospital of Dalian Medical University, No.222 Zhongshan Road, Xigang District, Dalian, 116011, China.
⁷ Institute of General Surgery, General Hospital of Eastern Theater Command of Chinese PLA, No.305 East Zhongshan Road, Xuanwu District, Nanjing, 210002, China.
⁸ Department of Gastrointestinal Surgery, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, No.420 Fuma Road, Jinan District, Fuzhou, 350014, China.
⁹ Department of General Surgery, The Fourth Hospital of Hebei Medical University, No.12 Jiankang Road, Shijiazhuang, 050011, China.
¹⁰ Department of General Surgery, Nanfang Hospital, Southern Medical University, No.1838 Guangzhoudadaobei Road, Guangzhou, 510515, China.
¹¹ Department of General Surgery, Tianjin Medical University General Hospital, No.154 Anshan Road, Heping District, Tianjin, 300052, China.
¹² Department of Gastric Cancer Surgery, Tianjin Medical University Cancer Hospital, West Huan-Hu Road, Ti Yuan Bei, Hexi District, Tianjin, 300060, China.
¹³ Department of General Surgery, Shanxi Provincial Cancer Hospital, No.3 Zhigongxincun, Xinghualing District, Taiyuan, 030013, China.
¹⁴ Department of General Surgery, The First Bethune Hospital of Jilin University, 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 Department of Gastric Surgery, Liaoning Cancer Hospital and Institute, No.44 Xiaoheyan Road, Dadong District, Shenyang, 110042, China.
¹⁷ Department of General Surgery, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Gulou District, Nanjing, 210029, China.
¹⁸ Department of General Surgery, Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital), No.42 Baiziting, Nanjing, 210009, China.
¹⁹ Department of General Surgery, The Affiliated Hospital of Qingdao University, No.16 Jiangsu Road, Shinan District, Qingdao, 266003, China.
²⁰ Department of Gastrointestinal Surgery, The First Affiliated Hospital, Sun Yat-sen University, No.58 Zhongshaner Road, Guangzhou, 510080, China.
²¹ Department of Gastric Surgery, Fudan University Shanghai Cancer Center, No.270 Dongan Road, Xuhui District, Shanghai, 200032, China.
²² Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, No.3 East Qingchun Road, Jianggan District, 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, Peking University Cancer Hospital, No.52 Fucheng Road, Haidian District, Beijing, 100142, China.
²⁵ Department of Gastroenterological Surgery, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
²⁶ Department of General Surgery, Beijing Friendship Hospital, 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, Beijing, 100053, China.
²⁸ Department of General Surgery, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, 100034, China.
²⁹ Department of Pancreatic and Gastric Surgery, Cancer Hospital, Chinese Academy 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, 73 Goryeodae-ro Seongbuk-gu, Seoul, 02841, South Korea.
³¹ Department of General Surgery & Institute of General Surgery, Chinese PLA General Hospital, No.28 Fuxing Road, Haidian District, Beijing, 100853, China. chenlinbj@yeah.net.

PMID: 33402102
PMCID: PMC7786891
DOI: 10.1186/s12885-020-07764-7

Abstract

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.

Keywords: Duration of neoadjuvant chemotherapy; Locally advanced gastric cancer; Oxaliplatin; S-1.

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Conflict of interest statement

The authors declare that they have no competing interests.

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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

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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

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