Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

This study is currently recruiting participants.
Verified February 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: February 10, 2014
Last verified: February 2014

March 8, 2006
February 10, 2014
August 2005
May 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
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The diagnosis of cholangiocarcinoma will be 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. Patient is a suitable candidate for OLT and judged a good candidate for the study by a radiation oncologist, a medical oncologist, and the liver transplant team.
  4. Maximum Eastern Cooperative Oncology Group performance status of 2 and a minimum daily caloric intake of 1200kcal.
  5. No evidence of metastatic disease.
  6. Between ages 18 - 70.
  7. Patient must provide written informed consent.

Exclusion Criteria:

  1. Patients with intrahepatic metastasis
  2. Patients with uncontrolled infections (sepsis)
  3. Patients undergoing prior attempts at resection
  4. Prior treatment with either irradiation or chemotherapy for this disease
  5. Evidence of extrahepatic disease, including local lymph node metastasis (except peri-hilar nodes).
  6. History of another malignancy diagnosed within 5 years, excluding superficial skin and cervical cancers
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
Washington University School of Medicine
February 2014

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