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Treatment using oxaliplatin and S-1 adjuvant chemotherapy for pathological stage III gastric cancer: a multicenter phase II study (TOSA trial) protocol

Authors :
Tsutomu Namikawa
Hiromichi Maeda
Hiroyuki Kitagawa
Koji Oba
Akihito Tsuji
Takaki Yoshikawa
Michiya Kobayashi
Kazuhiro Hanazaki
Source :
BMC Cancer, Vol 18, Iss 1, Pp 1-4 (2018)
Publication Year :
2018
Publisher :
BMC, 2018.

Abstract

Abstract Background Recent studies demonstrated the efficacy of S-1-based adjuvant chemotherapy administered for six months after curative surgery for stage III gastric cancer; however, it is unproven whether this type of combination chemotherapy is more effective than the standard adjuvant chemotherapy of S-1 for one year. Methods This multicenter phase II study evaluate the efficacy and safety of adjuvant chemotherapy using S-1 plus oxaliplatin followed by S-1 for up to one year for curatively resected stage III gastric cancer in patients aged over 20 years. Treatment initially comprises oral fluoropyrimidine S-1 (80 mg/m2) administered twice daily for the first 2 weeks of a 3-week cycle. On day 1 of a second 3-week cycle, patients will receive 100 mg/m2 of intravenous oxaliplatin followed by 80 mg/m2 of S-1 (maximum 8 cycles). Then, the patients will receive 80 mg/m2 of S-1 daily for 4 weeks, followed by 2 weeks of no chemotherapy. This 6-week cycle will be repeated during the first year after surgery. The primary endpoint is relapse-free survival for 3 years and secondary endpoints are safety, including the incidence of adverse events, and grading of neuropathy with each treatment cycle. The planned sample size of 75 patients is appropriate for this trial. The data will be analyzed on an intention-to-treat basis, assuming a two-sided test with a 5% level of significance. Discussion In contrast to previous trials, the current study involves administration of S-1 until one year after surgery in addition to prior S-1 plus oxaliplatin, and is the first study to evaluate the safety and efficacy of S-1 plus oxaliplatin followed by S-1 for up to one year in patients with curatively resected stage III gastric cancer. Trial registration This trial is registered in the University Hospital Medical Information Network’s Clinical Trials Registry (UMIN-CTR) registration number, R000029656 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029656). Registered January 24, 2017.

Details

Language :
English
ISSN :
14712407
Volume :
18
Issue :
1
Database :
Directory of Open Access Journals
Journal :
BMC Cancer
Publication Type :
Academic Journal
Accession number :
edsdoj.b1848eade5cd4718b837d1b13835e91b
Document Type :
article
Full Text :
https://doi.org/10.1186/s12885-018-4109-z