title: Randomized Phase III study of gemcitabine plus S-1 versus gemcitabine plus cisplatin in advanced biliary tract cancer: Japan Clinical Oncology Group Study (JCOG1113, FUGA-BT).
abstract: A Phase II selection design trial was conducted to identify the most promising regimen for comparison with standard therapy in chemo-naive patients with unresectable or recurrent biliary tract cancer (JCOG0805). Gemcitabine plus S-1 therapy showed better efficacy than S-1 monotherapy with acceptable safety in JCOG0805 study. Based on this result, a randomized Phase III trial was started in May 2013 to confirm the non-inferiority of gemcitabine plus S-1 therapy relative to gemcitabine plus cisplatin therapy, which is the current standard treatment for chemo-naive patients with unresectable or recurrent biliary tract cancer. A total of 350 patients will be accrued from 32 Japanese institutions within 4 years. The primary endpoint is overall survival, while the secondary endpoints are progression-free survival, adverse events, serious adverse events, clinically significant adverse events, response rate and %planned dose. This trial has been registered with the UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm) and the registration number is UMIN000010667.
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Tokyo.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo cmorizan@ncc.go.jp.
authors.forename: Chigusa
authors.initials: C
authors.lastname: Morizane
authors.affiliation: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo.
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Tokyo.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Katayama
authors.affiliation: Clinical Research Center, National Hospital Organization Shikoku Cancer Center, Ehime.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ishii
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Tokyo.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Department of Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D010094:Oxonic Acid / Q000008:administration & dosage; D018579:Patient Selection; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin; D000093542:Gemcitabine
keywords: Phase III; S-1; chemo-naive unresectable or recurrent biliary tract cancer; cisplatin; gemcitabine