Status:

TERMINATED

Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

Lead Sponsor:

Washington University School of Medicine

Conditions:

Cholangiocarcinoma

Eligibility:

All Genders

18+ years

Brief Summary

This is an observational study intended to validate results of a previous study done at the Mayo Clinic. Patients are treated with combination chemotherapy and radiation and maintained on oral Xeloda ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria:
  • A positive brush cytology or biopsy result obtained at the time of cholangiography;
  • Fluorescence in situ hybridization demonstrating aneuploidy;
  • A serum CA 19-9 value greater than 100 U/mL in the presence of a radiographically characteristic malignant stricture in the absence of cholangitis.
  • Listed for OLT for hilar cholangiocarcinoma
  • Tumor/stricture is above the cystic duct and is unresectable.
  • A suitable candidate for orthotopic liver transplantation as judged by the liver transplant team. All 3 treatment modalities are not needed to confirm eligibility for this registry trial.
  • \>/= 18 years of age.
  • Willing and able to provide written informed consent.

Exclusion

    Key Trial Info

    Start Date :

    August 12 2005

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 6 2023

    Estimated Enrollment :

    59 Patients enrolled

    Trial Details

    Trial ID

    NCT00301379

    Start Date

    August 12 2005

    End Date

    June 6 2023

    Last Update

    June 15 2023

    Active Locations (1)

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    Washington University School of Medicine

    St Louis, Missouri, United States, 63110