UMIN ID: C000000062
Registered date:16/08/2005
Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | advanced or recurrent gastric cancer |
Date of first enrollment | 2000/11/01 |
Target sample size | 690 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | continuous infusion of 5-fluorouracil combination of irinotecan and cisplatin oral administration of S-1 |
Outcome(s)
Primary Outcome | overall survival |
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Secondary Outcome | time to treatment failure, incidences of adverse events, response rate, non-hospitalized survival |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) patient with marked infection or inflammation 2) patient with severe peritoneal metastasis 3) patient with massive plueral effusion 4) patient with metastasis to CNS 5) patiet with diarrhea 4 or more times per day 6) patient severe medical condition 7) patient with other concurrent malignancy affecting on survival or adverse events 8) pregnant or nursing patient or with intent to bear baby 9) patient evaluated to be inadequate by a attending doctor 10) patient reqiring nutritional support |
Related Information
Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare,Taiho Pharmaceutical Co. Ltd., Yakult Honsha Co. Ltd. |
Secondary ID(s) | NCT00142350 |
Contact
public contact | |
Name | Narikazu Boku, MD |
Address | 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 Japan Japan |
Telephone | |
JCOG_sir@ml.jcog.jp | |
Affiliation | JCOG9912 Coordinating Office Div. of Gastrointestinal Oncology, Shizuoka Cancer Center |
scientific contact | |
Name | Atsushi Ohtsu, MD |
Address | 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan Japan |
Telephone | |
Affiliation | National Cancer Centr Hospital East Div. of Gastrointestinal Oncology and Endoscopy |