期刊
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
卷 43, 期 7, 页码 752-755出版社
OXFORD UNIV PRESS
DOI: 10.1093/jjco/hyt061
关键词
esophageal cancer; preoperative chemotherapy; preoperative chemoradiotherapy; clinical trial; Phase III
类别
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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