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

UMIN ID: UMIN000001703

Registered date:12/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced biliary tract cancer
• Date of first enrollment: 2008/10/01
• Target sample size: 62
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients receive gemcitabine (1,000 mg/m2, day 1,15) plus S-1 (80 mg/m2, day 1-14) combination therap every 4 weeks.
Patients receive gemcitabine (1,000 mg/m2, day 1,8,15) every 4 weeks.

Outcome(s)

• Primary Outcome: Tumor response (Response rate, Disease control rate)
• Secondary Outcome: progression-free survival, overall survival, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with an active concomitant infection 2) Patients with digestive ulcer or gastrointestinal bleeding 3) Patients with an active pulmonary fibrosis or interstitial pneumonia 4) Patients with an active concomitant malignancy 5) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 6) Patients with a previous history of a severe drug hypersensitivity 7) Patients receiving anti-cancer drugs 8) Patients with uncontrollable massive pleural effusion or massive ascites 9) Inappropriate patients for entry on this study in the judgement of the investigator

Related Information

• Primary Sponsor: Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
• Source(s) of Monetary Support: None