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Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00301379
First received: March 8, 2006
Last updated: November 17, 2014
Last verified: November 2014

March 8, 2006
November 17, 2014
August 2005
November 2015   (final data collection date for primary outcome measure)
  • Primary (Phase I): Proportion of patients with grade 3 or 4 DLT. [ Time Frame: Approximately 5 years. ] [ Designated as safety issue: Yes ]
  • Primary (Phase II): Rate of excess toxicity, proportion of patients with stable disease, or better, response at completion of chemoradiation, and the proportion of patients who are alive at 2 years after transplant. [ Time Frame: Approximatly 5 years. ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00301379 on ClinicalTrials.gov Archive Site
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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
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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
20
November 2015
November 2015   (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 is above the cystic duct and is unresectable.
  3. A suitable candidate for orthotopic liver transplantation as judged by a radiation oncologist, a medical oncologist, and the liver transplant team.
  4. Between ages 18 and 70 (inclusive).
  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)
Both
18 Years to 70 Years
No
Contact: William Chapman, MD 314-362-7792 chapmanw@wudosis.wustl.edu
Contact: Casey Rowe, MS, BS 314-362-8547 rowec@wudosis.wustl.edu
United States
 
NCT00301379
05-0651 / 201102096
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
November 2014

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