To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
690
overall survival
time to treatment failure
incidences of adverse events
response rate
non-hospitalized survival
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Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken, Japan
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan
Aomori Prefectural Central Hospital
Higashitsukurimiti,2-1-1,Aomori, Aomori, Japan
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
Asahi General Hospital
I-1326,Asahi, Chiba, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan
...and 24 more locations