Protocol digest of a phase III trial to evaluate the efficacy of preoperative chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with postoperative S-1 in locally advanced gastric cancer: Japan Clinical Oncology Group study JCOG1509 (NAGISA Trial)

被引：4

作者：

Mizusawa, Junki ^{[1
]}

Tokunaga, Masanori ^{[2
]}

Machida, Nozomu ^{[3
]}

Yabusaki, Hiroshi ^{[4
]}

Kawabata, Ryohei ^{[5
]}

Imamura, Hiroshi ^{[6
]}

Kinoshita, Takahiro ^{[7
]}

Nomura, Takashi ^{[8
]}

Nunobe, Souya ^{[9
]}

Tsuji, Kunihiro ^{[10
]}

Katayama, Hiroshi ^{[1
]}

Fukuda, Haruhiko ^{[1
]}

Boku, Narikazu ^{[11
]}

Yoshikawa, Takaki ^{[12
]}

Terashima, Masanori ^{[13
]}

机构：

[1] Natl Canc Ctr, Japan Clin Oncol Grp, Data Ctr, Operat Off, Tokyo, Japan

[2] Tokyo Med & Dent Univ, Dept Gastrointestinal Surg, Tokyo, Japan

[3] Kanagawa Canc Ctr, Dept Gastroenterol, Yokohama, Kanagawa, Japan

[4] Niigata Canc Ctr Hosp, Dept Gastroenterol Surg, Niigata, Japan

[5] Osaka Rosai Hosp, Dept Surg, Osaka, Japan

[6] Toyonaka City Hosp, Dept Surg, Osaka, Japan

[7] Natl Canc Ctr Hosp East, Dept Gastr Surg, Kashiwa, Chiba, Japan

[8] Yamagata Prefectural Cent Hosp, Dept Surg, Yamagata, Japan

[9] Canc Inst Hosp, Dept Gastr Surg, Tokyo, Japan

[10] Ishikawa Prefectural Cent Hosp, Dept Gastroenterol, Kanazawa, Ishikawa, Japan

[11] Univ Tokyo, IMSUT Hosp, Inst Med Sci, Dept Oncol & Gen Med, Tokyo, Japan

[12] Natl Canc Ctr, Dept Gastr Surg, Tokyo, Japan

[13] Shizuoka Canc Ctr, Dept Gastr Surg, Shizuoka, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2023年 / 53卷 / 02期

关键词：

gastric cancer; preoperative chemotherapy; LYMPH-NODE DISSECTION; NEOADJUVANT CHEMOTHERAPY; ADJUVANT CHEMOTHERAPY; CISPLATIN; SURGERY; SURVIVAL;

D O I：

10.1093/jjco/hyac154

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

In Japan, postoperative chemotherapy is a standard care for stage II/III gastric cancer after curative resection with D2 lymph node dissection, and the clinical outcomes of patients with stage Ill gastric cancer are unsatisfactory. A combination of oral S-1 and oxaliplatin, that is the standard chemotherapy regimen for unresectable advanced/recurrent gastric cancer associated with a high response rate, was considered the most promising preoperative chemotherapy regimen. This randomized phase Ill trial was started in September 2016 to confirm the superiority of preoperative chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with postoperative chemotherapy compared with D2 gastrectomy with postoperative chemotherapy for patients with clinical T3-4N1-3 M0 locally advanced gastric cancer in terms of overall survival. A total of 470 patients will be enrolled from 63 hospitals in Japan for 8.5 years. This trial has been registered in the Japan Registry of Clinical Trials as jRCTs031180350 [https://jrct.niph.go.jp/latest-detail/jRCTs031180350].

引用

页码：168 / 173

页数：6

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