Abstract | INTRODUCTION: METHODS AND ANALYSIS: This open-label, randomised phase II study will involve patients with advanced recurrent pancreatic cancer, aged ≥75 years, with favourable general conditions. Using the electronic data capture system, participants will be randomly allocated to groups with standard treatment (GEM therapy alone) and study treatment (GS therapy). The treatments will be administered until the conditions meet the discontinuation criteria. The primary endpoint is overall survival. ETHICS AND DISSEMINATION: This trial has been approved by the National Hospital Organisation's Central Review Board (H28-NHOD-01). DISCUSSION: This study will reveal if GS therapy could be a standard treatment option for elderly patients with pancreatic cancer, by clarifying its efficacy and safety. TRIAL REGISTRATION NUMBER: UMIN000025747; Pre-results.
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Authors | Hiroshi Ishii, Natsumi Yamashita, Makoto Ueno, Shinichi Ohkawa, Akiko M Saito, Mitsugu Sekimoto |
Journal | BMJ open gastroenterology
(BMJ Open Gastroenterol)
Vol. 5
Issue 1
Pg. e000187
( 2018)
ISSN: 2054-4774 [Print] England |
PMID | 29527313
(Publication Type: Journal Article)
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