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Completed

NCT Number: NCT01294085

Case Series Study of Biliary Tract Cancer Patients in Japan

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

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unresectable or recurrent biliary tract cancer

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. One year survival rate

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kansai Hepatobiliary Oncology Group

Network

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2011
Registry last updated
Nov 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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