NIPH Clinical Trials Search

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
Health condition(s) or Problem(s) studiedadvanced or recurrent gastric cancer
Date of first enrollment2000/11/01
Target sample size690
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)continuous infusion of 5-fluorouracil combination of irinotecan and cisplatin oral administration of S-1


Primary Outcomeoverall survival
Secondary Outcometime to treatment failure, incidences of adverse events, response rate, non-hospitalized survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Narikazu Boku, MD
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 Japan Japan
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
Affiliation National Cancer Centr Hospital East Div. of Gastrointestinal Oncology and Endoscopy