Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gyeongsang National University Hospital
• Collaborators: Chung-Ang University; Dong-A University; Samsung Medical Center
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Age : older than 20

• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2

• Histologically confirmed adenocarcinoma of the biliary tract

• Metastatic or unresectable biliary cancer

• No prior chemotherapy for biliary cancer

• A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)

• Adequate bone marrow, liver, renal function

Exclusion Criteria:

• A patient with no measurable disease

• A patient who received previous palliative chemotherapy for biliary cancer

• A patient who received adjuvant chemotherapy for biliary cancer within 1year

• A patient with previous active or passive immunotherapy.

• A pregnant or lactating patient