Case Series Study of Biliary Tract Cancer Patients in Japan

Completed

• Conditions: Biliary Tract Cancer

• Registration Number: NCT01294085
• Lead Sponsor: Kansai Hepatobiliary Oncology Group

Brief Summary

To assess the difference of prognosis between unresectable and recurrent biliary tract cancer and evaluate prognostic factors.

Detailed Description

Most patients of biliary tract cancer have advanced disease at diagnosis and often relapse despite surgery. Combination therapy of gemcitabine and cisplatin could be a standard therapy for this kind of cancer with the evidence of phase III study compared with gemcitabine alone. However the prognosis and the tolerability of chemotherapy in the patients with recurrent biliary tract cancer after radical resection might differ from those of unresectable biliary tract cancer, because the dose intensity of chemotherapy can be influenced by adjuvant chemotherapy and/or hepatic resection.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-03
• Primary Completion: 2011-02
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-11
• Study Completion: 2011-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Unresectable or recurrent biliary tract cancer

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One year survival rate	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival time	3 years
Number of participants with adverse events	3 years
Progression free survival	3 years

Trial Locations

Locations (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases; 🇯🇵 Osaka, Japan