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).
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| 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.
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| Authors | Kenichi Nakamura, Ken Kato, Hiroyasu Igaki, Yoshinori Ito, Junki Mizusawa, Nobutoshi Ando, Harushi Udagawa, Yasuhiro Tsubosa, Hiroyuki Daiko, Shuichi Hironaka, Haruhiko Fukuda, Yuko Kitagawa, Japan Esophageal Oncology Group/Japan Clinical Oncology Group |
| Journal | Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 43 Issue 7 Pg. 752-5 (Jul 2013) ISSN: 1465-3621 [Electronic] England |
| PMID | 23625063 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial) |
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