Case Series Study of Biliary Tract Cancer Patients in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kansai Hepatobiliary Oncology Group
ClinicalTrials.gov Identifier:
NCT01294085
First received: January 3, 2011
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

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


Condition
Biliary Tract Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Analysis of the Difference of Prognosis Between Unresectable and Recurrent Biliary Tract Cancer

Resource links provided by NLM:


Further study details as provided by Kansai Hepatobiliary Oncology Group:

Primary Outcome Measures:
  • One year survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival time [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

300

Criteria

Inclusion Criteria:

  • Unresectable or recurrent biliary tract cancer

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294085

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

No publications provided

Responsible Party: Kansai Hepatobiliary Oncology Group
ClinicalTrials.gov Identifier: NCT01294085     History of Changes
Other Study ID Numbers: KHBO1001, UMIN000004530
Study First Received: January 3, 2011
Last Updated: November 24, 2011
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014