Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)

UMIN ID: UMIN000001685

Registered date:04/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: biliary tract neoplasm
• Date of first enrollment: 2009/02/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
B: Patients receive S-1 alone (80-120 mg/day, day1-28 every 6 weeks). It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.

Outcome(s)

• Primary Outcome: overall survival (1-year survival)
• Secondary Outcome: progression-free survival, response rate, adverse events, severe adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia or fibroid lung 6) Watery diarrhea 7) Active bacterial or fungous infection 8) Severe complication 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare