Case Series Study of Biliary Tract Cancer Patients in Japan

November 24, 2011 updated by: Kansai Hepatobiliary Oncology Group

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Osaka Medical Center for Cancer and Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

300

Description

Inclusion Criteria:

  • Unresectable or recurrent biliary tract cancer

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
One year survival rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival time
Time Frame: 3 years
3 years
Progression free survival
Time Frame: 3 years
3 years
Number of participants with adverse events
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansai Hepatobiliary Oncology Group

Investigators

  • Study Director: Tatsuya Ioka, MD, Osaka Medical Center for Cancer and CVD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2011

Last Update Submitted That Met QC Criteria

November 24, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHBO1001
  • UMIN000004530 (Registry Identifier: UMIN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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