Randomized phase II study of gemcitabine plus S-1 combination therapy vs. S-1 in advanced biliary tract cancer: Japan Clinical Oncology Group Study (JCOG0805)

Japanese Journal of Clinical Oncology
Atsuo TakashimaJunji Furuse

Abstract

A randomized Phase II selection design trial comparing gemcitabine plus S-1 combination therapy with S-1 monotherapy for chemo-naïve unresectable or recurrent biliary tract cancer patients was started in Japan. The aim of this trial is to evaluate the efficacy and safety of the two regimens and to determine which is more promising as a test arm regimen to be compared with the current standard regimen, gemcitabine plus cisplatin, in a subsequent Phase III trial. Patients with unresectable or recurrent biliary tract cancer are randomized to either gemcitabine plus S-1 combination therapy arm or S-1 monotherapy arm. A total of 100 patients will be accrued for this study from 18 institutions over 1 year. The primary endpoint is the proportion of 1-year overall survival, and the secondary endpoints are progression-free survival, response rate and adverse events.

References

Sep 6, 2005·Cancer Chemotherapy and Pharmacology·Takuji OkusakaToshio Tsuyuguchi
Jan 25, 2008·Cancer Chemotherapy and Pharmacology·Junji FuruseAkihiro Funakoshi
Feb 16, 2008·Journal of Hepato-biliary-pancreatic Surgery·Junji FuruseUNKNOWN Japan Society of Clinical Oncology
May 2, 2008·The Oncologist·Aram F Hezel, Andrew X Zhu
Apr 9, 2010·The New England Journal of Medicine·Juan ValleUNKNOWN ABC-02 Trial Investigators

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Citations

Feb 12, 2013·Acta Pharmacologica Sinica·Zhi-xiang ZhuangHong Zhang
Aug 13, 2014·Indian Journal of Surgical Oncology·Bhawna SirohiShailesh V Shrikhande
Feb 14, 2012·Journal of Gastrointestinal Cancer·Adriana RomitiPaolo Marchetti
Aug 1, 2012·Journal of Gastroenterology·Masato Nagino
Jan 8, 2013·Surgical Oncology·Charles Henry Caldow PilgrimT Clark Gamblin
Feb 25, 2011·Langenbeck's Archives of Surgery·Isao KurosakiKatsuyoshi Hatakeyama
Mar 30, 2012·Journal of Hepato-biliary-pancreatic Sciences·Junji FuruseFumio Nagashima
Mar 31, 2016·Japanese Journal of Clinical Oncology·Junki MizusawaUNKNOWN Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group
Feb 18, 2015·Cancer Chemotherapy and Pharmacology·Hirotoshi IshiwatariJunji Kato
Mar 21, 2019·Liver International : Official Journal of the International Association for the Study of the Liver·Jorge AdevaJuan W Valle
Jan 8, 2017·Surgical Case Reports·Misuzu YamadaToshio Nakagohri

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