Status:

COMPLETED

Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

Lead Sponsor:

Yonsei University

Conditions:

Biliary Tract Cancer

Eligibility:

All Genders

17-75 years

Phase:

PHASE2

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2010

    Estimated Enrollment :

    39 Patients enrolled

    Trial Details

    Trial ID

    NCT00832689

    Start Date

    June 1 2008

    End Date

    March 1 2010

    Last Update

    March 28 2011

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Severance hospital

    Seoul, South Korea, 120750