Case Series Study of Biliary Tract Cancer Patients in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01294085
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : November 28, 2011
Information provided by (Responsible Party):
Kansai Hepatobiliary Oncology Group

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

Condition or disease
Biliary Tract Cancer

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
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Analysis of the Difference of Prognosis Between Unresectable and Recurrent Biliary Tract Cancer
Study Start Date : November 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. One year survival rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival time [ Time Frame: 3 years ]
  2. Number of participants with adverse events [ Time Frame: 3 years ]
  3. Progression free survival [ Time Frame: 3 years ]

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  • Unresectable or recurrent biliary tract cancer

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01294085

Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan
Sponsors and Collaborators
Kansai Hepatobiliary Oncology Group
Study Director: Tatsuya Ioka, MD Osaka Medical Center for Cancer and CVD

Responsible Party: Kansai Hepatobiliary Oncology Group Identifier: NCT01294085     History of Changes
Other Study ID Numbers: KHBO1001
UMIN000004530 ( Registry Identifier: UMIN )
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases