Three-arm Phase III Trial Comparing Cisplatin Plus 5-FU (CF) Versus Docetaxel, Cisplatin Plus 5-FU (DCF) Versus Radiotherapy with CF (CF-RT) as Preoperative Therapy for Locally Advanced Esophageal Cancer (JCOG1109, NExT Study)

被引：270

作者：

Nakamura, Kenichi ^{[1
]}

Kato, Ken ^{[2
]}

Igaki, Hiroyasu ^{[3
]}

Ito, Yoshinori ^{[4
]}

Mizusawa, Junki ^{[1
]}

Ando, Nobutoshi ^{[5
]}

Udagawa, Harushi ^{[6
]}

Tsubosa, Yasuhiro ^{[7
]}

Daiko, Hiroyuki ^{[8
]}

Hironaka, Shuichi ^{[9
]}

Fukuda, Haruhiko ^{[1
]}

Kitagawa, Yuko ^{[10
]}

机构：

[1] Natl Canc Ctr, JCOG Data Ctr, Operat Off, Multiinst Clin Trial Support Ctr, Tokyo 104, Japan

[2] Natl Canc Ctr, Gastrointestinal Med Oncol Div, Tokyo 1040045, Japan

[3] Natl Canc Ctr, Esophageal Surg Div, Tokyo 1040045, Japan

[4] Natl Canc Ctr, Dept Radiat Oncol, Tokyo 1040045, Japan

[5] Ichikawa Gen Hosp, Dept Surg, Tokyo Dent Coll, Chiba, Japan

[6] Toranomon Gen Hosp, Dept Surg Gastroenterol, Tokyo, Japan

[7] Shizuoka Canc Ctr, Div Esophageal Surg, Shizuoka, Japan

[8] Natl Canc Ctr Hosp East, Dept Esophageal Surg, Chiba, Japan

[9] Chiba Canc Ctr, Clin Trial Promot Dept, Chiba 2608717, Japan

[10] Keio Univ, Sch Med, Dept Surg, Tokyo 160, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2013年 / 43卷 / 07期

关键词：

esophageal cancer; preoperative chemotherapy; preoperative chemoradiotherapy; clinical trial; Phase III; CHEMOTHERAPY; SURVIVAL; CARCINOMA;

D O I：

10.1093/jjco/hyt061

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A three-arm Phase III trial was started in November 2012. Preoperative chemotherapy with cisplatin plus 5-fluorouracil is the current standard treatment for locally advanced esophageal cancer in Japan, while preoperative chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries. Preoperative chemotherapy with docetaxel, cisplatin plus 5-fluorouracil is another promising regimen. The purpose of this study is to confirm the superiority of docetaxel, cisplatin plus 5-fluorouracil over cisplatin plus 5-fluorouracil and the superiority of cisplatin plus 5-fluorouracil with chemoradiotherapy over cisplatin plus 5-fluorouracil as preoperative therapy for squamous cell carcinoma of esophagus. A total of 501 patients will be accrued from 41 Japanese institutions within 6.25 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, R0 resection, response rate, pathologic complete response rate and adverse events.

引用

页码：752 / 755

页数：4

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