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Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

This study is currently recruiting participants.
Verified May 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301379
First Posted: March 10, 2006
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
March 8, 2006
March 10, 2006
May 4, 2017
August 2005
December 31, 2017   (Final data collection date for primary outcome measure)
Proportion of patients withdrawn due to toxicity and other treatment related events. [ Time Frame: Completion of treatment for all patients (estimated to be 13 years total) ]
Not Provided
Complete list of historical versions of study NCT00301379 on ClinicalTrials.gov Archive Site
  • Proportion of patients who respond to treatment [ Time Frame: 2 years ]
    -Response is defined as an absence of progressive disease or metastasis, so that the patient remains a candidate for liver transplantation
  • Overall survival [ Time Frame: 2 years ]
  • Disease-free survival [ Time Frame: 2 years ]
Not Provided
Not Provided
Not Provided
 
Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients
Prospective Registry Study of Neoadjuvant Chemoradiation in Conjunction With Liver Transplantation for Cholangiocarcinoma With Induction Gemcitabine, Followed by 3D Conformal Radiation With 5-FU as a Radiosensitizer, and Maintenance Xeloda Therapy Until Liver Transplantation
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 until they can receive liver transplant. A staging laparotomy is performed before chemoradiation in order to identify patients who will most benefit from the treatment and to improve outcomes.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Primary care clinic.
Cholangiocarcinoma
Other: Observation data collection study.
This is a data collection study where the main purpose is to collect information about the treatments patients receive for their unresectable cholangiocarcinoma.
1
Patients with unresectable cholangiocarcinoma.
Intervention: Other: Observation data collection study.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 31, 2019
December 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria:

    1. A positive brush cytology or biopsy result obtained at the time of cholangiography;
    2. Fluorescence in situ hybridization demonstrating aneuploidy;
    3. 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.
  2. Tumor/stricture is above the cystic duct and is unresectable.
  3. 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.
  4. >/= 18 years of age.
  5. Willing and able to provide written informed consent.

Exclusion Criteria:

  1. Intrahepatic metastasis or other metastatic disease (except peri-hilar nodes).
  2. Prior treatment for this disease (including attempts at resection, irradiation, or chemotherapy)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: William Chapman, MD 314-362-7792 chapmanwc@wustl.edu
Contact: Tracey Guthrie 314-747-4404 guthriet@wustl.edu
United States
 
 
NCT00301379
05-0651 / 201102096
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: William C. Chapman, M.D. Washington University School of Medicine
Washington University School of Medicine
May 2017