alexa Feasibility Study of Bolus 5-Fluorouracil+L-Leucovorin as Salvage Line Chemotherapy for Oral Fluorouracil-Resistant Unresectable Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group Study HGCSG1502| Abstract
ISSN: 2167-0870

Journal of Clinical Trials
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  • Protocol Article   
  • J Clin Trials 2017,
  • DOI: 10.4172/2167-0870.1000337

Feasibility Study of Bolus 5-Fluorouracil+L-Leucovorin as Salvage Line Chemotherapy for Oral Fluorouracil-Resistant Unresectable Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group Study HGCSG1502

Tetsuhito Muranaka1, Yoshito Komatsu1*, Masataka Yagisawa1, Kentaro Sawada1, Kazuaki Harada1, Yasuyuki Kawamoto1, Hiroshi Nakatsumi1, Satoshi Yuki2, Kota Ono3, Shuhei Kawahata4, Yoshimitsu Kobayashi5, Susumu Sogabe5, Takuto Miyagishima5, Kazuteru Hatanaka6, Takahide Sasaki7, Masayoshi Dazai8, Ichiro Iwanaga9, Atsushi Ishiguro10, Michio Nakamura11, Naoya Sakamoto2 and Yuh Sakata12
1Cancer Center, Hokkaido University Hospital, Japan
2Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Japan
3Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Japan
4Gastroenterology, Obihiro Kosei Hospital, , Japan
5Medical Oncology, Kushiro Rosai Hospital, , Japan
6Gastroenterology, Hakodate Municipal Hospital, , Japan
7Internal Medicine, Hokkaido Gastroenterology Hospital, , Japan
8Gastroenterology, Sapporo Medical Center NTT EC, , Japan
9Medical Oncology, Japanese Red Cross Kitami Hospital, , Japan
10Medical Oncology, Teine Keijinkai Hospital, , Japan
11Gastroenterology, Sapporo City General Hospital, , Japan
12Medical Oncology, Misawa City Hospital, , Japan
*Corresponding Author : Yoshito Komatsu, Cancer Center, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo City, 060-0814, Hokkaido, Japan, Tel: +81-823-66-2314, Fax: +81 11706-7999, Email: [email protected]

Received Date: Dec 18, 2017 / Accepted Date: Dec 26, 2017 / Published Date: Dec 28, 2017

Abstract

In November 2015 we began a feasibility study of salvage line chemotherapy with 5-fluorouracil and l-leucovorin given in an intravenous bolus once weekly followed by a 2-week rest period within a 8-week cycle in patients with gastric cancer resistant to other chemotherapies. This study aims to assess the safety and efficacy of this treatment and determine whether the treatment has an adverse effect on patients’ quality of life. In total, 38 patients with chemotherapy-resistant advanced or recurrent gastric cancer will be recruited to this study. The primary end point is 8-week progression-free survival after the date of first treatment; the major secondary end points are progressionfree survival, overall survival, and quality of life assessed by European Organization for Research and Treatment of Cancer QLQ-C30 (quality of life score-30) and QLQ-STO22 (quality of life for gastric cancer patients) questionnaires. Based on the results of the study, we will conduct further trials to compare this treatment with best supportive care only.

Keywords: Gastric cancer; Chemotherapy; 5-Fluorouracil; Leucovorin

Citation: Muranaka T, Komatsu Y, Yagisawa M, Sawada K, Harada K, et al. (2017) Feasibility Study of Bolus 5-Fluorouracil+L-Leucovorin as Salvage Line Chemotherapy for Oral Fluorouracil-Resistant Unresectable Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group Study HGCSG1502. J Clin Trials 7: 337. Doi: 10.4172/2167-0870.1000337

Copyright: © 2017 Muranaka T, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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