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Logo of bmccancBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Cancer
 
BMC Cancer. 2012; 12: 307.
Published online 2012 July 23. doi:  10.1186/1471-2407-12-307
PMCID: PMC3488329
Copyright ©2012 Tsuburaya et al.; licensee BioMed Central Ltd.
A randomized phase II trial to elucidate the efficacy of capecitabine plus cisplatin (XP) and S-1 plus cisplatin (SP) as a first-line treatment for advanced gastric cancer: XP ascertainment vs. SP randomized PII trial (XParTS II)
Akira Tsuburaya,corresponding author1 Satoshi Morita,2 Yasuhiro Kodera,3 Michiya Kobayashi,4 Kohei Shitara,5 Kensei Yamaguchi,6 Takaki Yoshikawa,1 Kazuhiro Yoshida,7 Shigefumi Yoshino,8 and Jun-ichi Sakamoto9
1Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, 241-0815, Yokohama, Asahi-ku, Japan
2Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan
3Department of Surgery II, Nagoya University Graduate School of Medicine, Nagoya, Japan
4Department of Surgery, Kochi Medical School, Kochi, Japan
5Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
6Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan
7Department of Surgical Oncology, Gifu Graduate School of Medicine, Gifu, Japan
8Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine, Ube, Japan
9Epidemiological and Clinical Research Information Network, Nagoya University Graduate School of Medicine, Aichi, Nagoya, Japan
corresponding authorCorresponding author.
Akira Tsuburaya: tuburayaa/at/kcch.jp; Satoshi Morita: smorita/at/urahp.yokohama-cu.ac.jp; Yasuhiro Kodera: ykodera/at/med.nagoya-u.ac.jp; Michiya Kobayashi: kobayasm/at/med.kochi-u.ac.jp; Kohei Shitara: kouheis0824/at/yahoo.co.jp; Kensei Yamaguchi: k-yamaguchi/at/cancer-c.pref.saitama.jp; Takaki Yoshikawa: yoshikawat/at/kcch.jp; Kazuhiro Yoshida: kyoshida/at/gifu-u.ac.jp; Shigefumi Yoshino: sigefumi/at/po.cc.yamaguchi-u.ac.jp; Jun-ichi Sakamoto: sakamjun/at/med.nagoya-u.ac.jp
Received April 19, 2012; Accepted July 6, 2012.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background
On the basis of international clinical trials, capecitabine plus cisplatin (XP) as a first-line treatment of advanced gastric cancer is considered a global standard regimen. However, the usefulness of XP as compared with S-1 plus cisplatin (SP), which is considered standard therapy in Japan, has not yet been assessed.
Methods/design
This is a multicenter randomized phase II trial to elucidate the efficacy of XP as compared with SP for first-line treatment of advanced gastric cancer. Patients with unresectable metastatic or recurrent gastric cancer, 20–74 years of age and human epidermal growth factor 2 (HER2)-negative status, will be assigned in a 1:1 ratio to receive either S-1 40 mg/m2 bid for 21 days plus cisplatin 60 mg/m2 (day 8) every 5-week cycle or capecitabine 1000 mg/m2 bid for 14 days plus cisplatin 80 mg/m2 (day 1) every 3-week cycle. Patients will be also asked to the analysis of tumor tissues for translational investigations. The Primary endpoint is progression-free survival and secondary endpoints are overall survival, time to treatment failure, tumor response rate and safety. These comparisons will also be evaluated in terms of biomarkers. Planned sample size is 100 (50 in each arm), which is appropriate for this trial.
Discussion
Fluoropyrimidine plus cisplatin combination is the standard regimen of the first line treatment for advanced gastric cancer. Both S-1 and capecitabine are the prodrug of 5-FU but differ from their process of metabolism. Result of this trial and translational research will provide the important clues to prepare the individualized therapy for advanced gastric cancer in the near future.
Trial registration
ClinicalTrials.gov Identifier NCT01406249
Keywords: Biomarker, Capecitabine, Cisplatin, Clinical trial, Gastric cancer, S-1
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