Phase II study of gemcitabine/S-1 combination therapy in patients with non-resectable advanced biliary tract cancer

UMIN ID: UMIN000000792

Registered date:08/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-resectable biliary tract cancer or recurrent biliary tract cancer post surgical treatment
• Date of first enrollment: 2007/08/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Gemcitibine 1000 mg/m2 is infused in 30 min on day 1 and 8, and S-1 60 mg/m2 is given orally daily for 14 consecutive days. The cycle is repeated every 3 weeks until disease progression, unacceptable adverse events, patient withdrawal or death.

Outcome(s)

• Primary Outcome: Overall survival (OS)
• Secondary Outcome: response rate (RR) adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients who are pregnant or lactating, or have an intention to get pregnant 5. Patients with a history of severe drug allery 6. Patients with other serious comorbid disease 7. Patinets with serious mental disease 8. Patients who are judged inappropriate for the entry into the study by the investigater

Related Information

• Primary Sponsor: Kyoto University Hospital
• Source(s) of Monetary Support: none