A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
- Conditions
- Gastric Cancer
- Registration Number
- NCT00142350
- Lead Sponsor
- Japan Clinical Oncology Group
- Brief Summary
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
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 690
- unresectable or recurrent histologically proved gastric cancer
- adequate oral intake
- age 20 or older and 75 or younger
- Performance Status (ECOG):0, 1, 2
- measurable or unmeasurable lesions
- preserved organ functions
- no severe medical condition
- no prior chemotherapy for gastric cancer
- written informed consent
- patient with marked infection or inflammation
- patient with severe peritoneal metastasis
- patient with massive pleural effusion
- patient with metastasis to CNS
- patient with diarrhea 4 or more times per day
- patient severe medical condition
- patient with other concurrent malignancy affecting on survival or adverse events
- pregnant or nursing patient or with intent to bear baby
- patient evaluated to be inadequate by a attending doctor
- patient requiring nutritional support
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method time to treatment failure incidences of adverse events response rate non-hospitalized survival
Trial Locations
- Locations (34)
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Hyogo Medical Center for Adults
🇯🇵Akashi,Kitaouji-cho,13-70, Hyogo, Japan
Kyoto University Hospital
🇯🇵Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan
Showa University School of Medicine
🇯🇵Shinagawa-ku,Hatanodai,1-5-8, Tokyo, Japan
Cancer Institute Hospital
🇯🇵Koto-ku,Ariake,3-10-6, Tokyo, Japan
Aomori Prefectural Central Hospital
🇯🇵Higashitsukurimiti,2-1-1,Aomori, Aomori, Japan
Yokohama City University Medical Center
🇯🇵Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan
Asahi General Hospital
🇯🇵I-1326,Asahi, Chiba, Japan
Nagoya Medical Center
🇯🇵Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan
Aichi Cancer Center,Aichi Hospital
🇯🇵Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan
Chiba Cancer Center Hospital
🇯🇵Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 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
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
Iwate Prefectural Central Hospital
🇯🇵Morioka,Ueda,1-4-1, Iwate, Japan
Hokkaido University Hospital
🇯🇵North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Federation of national public service personnel mutual aid associations Tonan Hospital
🇯🇵kita 1 nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan
Kobe University Graduate School of Medicine
🇯🇵Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyogo, Japan
Kitasato University East Hospital
🇯🇵Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
🇯🇵Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan
Yokohama Mucipical Citizen's Hospital
🇯🇵Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan
Kanagawa Cancer Center
🇯🇵Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Kochi Health Science Center
🇯🇵Kochi,Ike,2125-1, Kochi, Japan
Kumamoto Regional Medical Center Hospital
🇯🇵Kumamoto,Honjo,5-16-10, Kumamoto, Japan
Tohoku University Hospital
🇯🇵Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Saku Central Hospital
🇯🇵Saku,Usuda,197, Nagano, Japan
Saitama Medical School Hospital
🇯🇵Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, Japan
Saitama Cancer Center
🇯🇵Kita-adachi,Ina,Komuro,818, Saitama, Japan
Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
🇯🇵Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007, Shizuoka, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
Osaka Medical College
🇯🇵Takatsuki,Daigakucho,2-7, Osaka, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata,Aoyagi,1800, Yamagata, Japan