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Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

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ClinicalTrials.gov Identifier: NCT00832689
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : March 28, 2011
Information provided by:
Yonsei University

January 29, 2009
January 30, 2009
March 28, 2011
June 2008
February 2010   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00832689 on ClinicalTrials.gov Archive Site
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Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
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The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.
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Phase 2
Primary Purpose: Treatment
Biliary Tract Cancer
Drug: Irinotecan and Gemcitabine
Experimental: 1
Intervention: Drug: Irinotecan and Gemcitabine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed inoperable biliary tract cancer
  • Age: 18 ~75 years old
  • Performance status: ECOG 0-2
  • Hematopoietic:

    • Granulocyte count at least 1,500/mm3
    • Platelet count at least 100,000/mm3
  • Hepatic:

    • Bilirubin No greater than 2 fold the upper normal limit
    • AST/ALT : No greater than 3 fold the upper normal limit
  • Renal:

    • Creatinine - no greater than 1.5 mg/dL
  • Not pregnant
  • No other serious medical or psychiatric illness that would preclude giving informed consent or limit
  • No prior chemotherapy within 6 months
  • No other concurrent anticancer radiotherapy within 6 months
Sexes Eligible for Study: All
17 Years to 75 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Seung Woo Park, Professor, Severance hospital
Yonsei University
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Study Director: Jeong Youp Park, MD Assistant professor of division of Gastroenterology
Yonsei University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP