Case Series Study of Biliary Tract Cancer Patients in Japan

Biliary Tract Cancer Clinical Trial

Official title:

Retrospective Analysis of the Difference of Prognosis Between Unresectable and Recurrent Biliary Tract Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294085
• Other study ID #: KHBO1001
• Secondary ID: UMIN000004530
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: November 24, 2011
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Kansai Hepatobiliary Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Unresectable or recurrent biliary tract cancer

Exclusion Criteria:

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Locations

Country	Name	City	State
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kansai Hepatobiliary Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One year survival rate		1 year
Secondary	Overall survival time		3 years
Secondary	Number of participants with adverse events		3 years
Secondary	Progression free survival		3 years