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Pancreatic cancer
A randomised controlled trial of gemcitabine hydrochloride plus S-1 combination therapy versus gemcitabine hydrochloride therapy alone in pancreatic cancer patients aged ≥75 years: a study protocol for an open-label randomised feasibility study
  1. Hiroshi Ishii1,2,
  2. Natsumi Yamashita1,
  3. Makoto Ueno3,
  4. Shinichi Ohkawa3,
  5. Akiko M Saito2,
  6. Mitsugu Sekimoto4
  1. 1 Clinical Research Center, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan
  2. 2 Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan
  3. 3 Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan
  4. 4 Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan
  1. Correspondence to Dr Hiroshi Ishii; hiishii{at}shikoku-cc.go.jp

Abstract

Introduction In Japan, the age of patients with pancreatic cancer has increased. Combination chemotherapies such as 5-fluorouracil/leucovorin, oxaliplatin and irinotecan therapy and gemcitabine hydrochloride (GEM) +nab paclitaxel therapy have been developed as the standard treatments for young patients with advanced recurrent pancreatic cancer. However, both therapies produce toxicity and their administration is limited by the patients’ age or performance status. The efficacy and safety data obtained in the GEST study—a large-scale randomised controlled study conducted in patients with pancreatic cancer in Japan—suggested that GEM +S-1 (GS) combination therapy is a promising candidate for those aged between 75 and 80 years. However, for patients aged ≥80 years, no efficacy or safety data on GS therapy are currently available.

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.

  • pancreatic cancer
  • gemcitabine hydrochloride
  • gemcitabine hydrochloride + S-1 combination therapy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjgast-2017-000187

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    Footnotes

    • Contributors HI: prepared the study protocol, and will provide the final approval, perform an overview of the entire study through the study management committee and manage safety information. NY: will perform the statistical analyses. MU, SO and MS: will plan, investigate and manage the study. AMS: will support the preparation of the protocol and quality control (data management and monitoring).

    • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.