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)

Kenichi Nakamura, Ken Kato, Hiroyasu Igaki, Yoshinori Ito, Junki Mizusawa, Nobutoshi Ando, Harushi Udagawa, Yasuhiro Tsubosa, Hiroyuki Daiko, Shuichi Hironaka, Haruhiko Fukuda, Yuko Kitagawa

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118 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)752-755
Number of pages4
JournalJapanese journal of clinical oncology
Volume43
Issue number7
DOIs
Publication statusPublished - 2013 Jul 1

Keywords

  • Clinical trial
  • Esophageal cancer
  • Phase III
  • Preoperative chemoradiotherapy
  • Preoperative chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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