Skip Navigation


Japanese Journal of Clinical Oncology Advance Access originally published online on November 7, 2005
Japanese Journal of Clinical Oncology 2005 35(11):672-675; doi:10.1093/jjco/hyi179
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
35/11/672    most recent
hyi179v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (5)
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Tsuburaya, A.
Right arrow Articles by Macdonald, J. S.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Tsuburaya, A.
Right arrow Articles by Macdonald, J. S.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?


© 2005 Foundation for Promotion of Cancer Research

Clinical Trial Note

A Randomized Phase III trial of Post-operative Adjuvant Oral Fluoropyrimidine versus Sequential Paclitaxel/Oral Fluoropyrimidine; and UFT versus S1 for T3/T4 Gastric Carcinoma: The Stomach Cancer Adjuvant Multi-institutional Trial Group (Samit) Trial

Akira Tsuburaya1, Junichi Sakamoto2, Satoshi Morita3, Yasuhiro Kodera4, Michiya Kobayashi5, Yumi Miyashita6 and John S. Macdonald7

1 Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, 2 Department of Epidemiological and Clinical Information Management, 3 Department of Epidemiology and Healthcare Research, Kyoto University, Kyoto, 4 Department of Surgery, Nagoya University, Nagoya, 5 Department of Surgery, Kochi University, Kochi, 6 Department of Clinical research of Aichi Cancer Center Aichi Hospital, Okazaki, Japan and 7 Gastrointestinal Oncology Service, St Vincent's Comprehensive Cancer Center, New York, NY, USA

For reprints and all correspondence: Akira Tsuburaya, Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, 1-1-2, Nakao, Asahi-ku, Yokohama 2410815, Japan. E-mail: tuburayaa{at}kcch.jp

Received August 2, 2005; accepted September 6, 2005

Paclitaxel, S1 and their combined sequential administration is proposed to be examined installing UFT as an active control of adjuvant chemotherapy for curatively resected T3–4 gastric cancer in a multicenter Phase III trial. The primary endpoint is disease-free survival and the secondary endpoints are incidence of adverse events, overall survival and compliance. The sample size is 370 per treatment arm (1480 in total) for two hypotheses of the superiority of sequential use of paclitaxel followed by oral fluoropyrimidines to fluoropyrimidines (UFT/S1) alone and the non-inferiority of S1 to UFT to be tested by two-by-two factorial design. Abdominal CT or US is performed every 3 months in the first 2 years and every 6 months thereafter for 3 years in total to ensure recurrence data collection. This trial could appraise sequential combination therapy and efficacy of new drugs as adjuvant for gastric cancer treatment.

Key Words: adjuvant chemotherapy • gastric cancer • UFT • S1 • paclitaxel


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Jpn J Clin OncolHome page
Y. Ueda, T. Fujimura, S. Kinami, Y. Hirono, A. Yamaguchi, H. Naitoh, T. Tani, M. Kaji, H. Yamagishi, K. Miwa, et al.
A Randomized Phase III Trial of Postoperative Adjuvant Therapy with S-1 Alone versus S-1 plus PSK for Stage II/IIIA Gastric Cancer: Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC)
Jpn. J. Clin. Oncol., August 1, 2006; 36(8): 519 - 522.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.