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Japanese Journal of Clinical Oncology Advance Access published online on November 7, 2005
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi179
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© 2005 Foundation for Promotion of Cancer Research
Received August 2, 2005
Accepted September 6, 2005

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 Tsuburaya 1*, Junichi Sakamoto 2, Satoshi Morita 3, Yasuhiro Kodera 4, Michiya Kobayashi 5, Yumi Miyashita 6, and John S. Macdonald 7

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

* To whom correspondence should be addressed.
Akira Tsuburaya, E-mail: tuburayaa{at}kcch.jp


  Abstract

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.

Keywords: adjuvant chemotherapy; gastric cancer; UFT; S1; paclitaxel.
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[Abstract] [Full Text] [PDF]


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