title: 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).
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.
authors.affiliation: JCOG Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Igaki
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.forename: Nobutoshi
authors.initials: N
authors.lastname: Ando
authors.forename: Harushi
authors.initials: H
authors.lastname: Udagawa
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Tsubosa
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Daiko
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hironaka
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D018579:Patient Selection; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Phase III; clinical trial; esophageal cancer; preoperative chemoradiotherapy; preoperative chemotherapy