Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer

UMIN ID: UMIN000001595

Registered date:22/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced bile duct cancer
• Date of first enrollment: 2009/01/01
• Target sample size: 110
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A:Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15 every 4 weeks.
Group B:TS-1 80mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks.

Outcome(s)

• Primary Outcome: Overall survival(OS)
• Secondary Outcome: Progression free survival(PFS) Adverse events QOL Response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.lung fibrosis or intestinal pneumonia 2.Watery diarrhea 3.Severe infection 4.Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5.Medical history of serious allergy reactions to any drug 6.Massive pleural or abdominal effusion 7.Metastasis to central nervous system 8.Active synchronous or metachronous malignancy other than carcinoma in situ 9.Regular use of frucitocin, fenitoin or warfarin 10.Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 11.Severe mental illness 12.Patients who are judged inappropriate for the entry into the study by the investigater

Related Information

• Primary Sponsor: Osaka International Cancer Institute Department of Hepatobiliary and pancreatic Oncology
• Source(s) of Monetary Support: Osaka foundation for the prevention of cancer and cardiovascular diseases