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: Junki Mizusawa, Chigusa Morizane, Takuji Okusaka, Hiroshi Katayama, Hiroshi Ishii, Haruhiko Fukuda, Junji Furuse, Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 46 Issue 4 Pg. 385-8 (Apr 2016) ISSN: 1465-3621 [Electronic] England
• PMID: 27025903 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected].

Chemical References

• Drug Combinations
• Deoxycytidine
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Cisplatin
• Gemcitabine

Topics

• Adult
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Biliary Tract Neoplasms (drug therapy, mortality)
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease-Free Survival
• Drug Combinations
• Female
• Humans
• Japan
• Male
• Oxonic Acid (administration & dosage)
• Patient Selection
• Tegafur (administration & dosage)
• Treatment Outcome
• Gemcitabine