Case Series Study of Biliary Tract Cancer Patients in Japan

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01294085

Enrollment

300

Registered

2011-02-11

Start date

2010-11-30

Completion date

2011-08-31

Last updated

2011-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Unresectable or recurrent biliary tract cancer

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
One year survival rate	1 year

Secondary

Measure	Time frame
Overall survival time	3 years
Number of participants with adverse events	3 years
Progression free survival	3 years

Countries

Japan

Outcome results