Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cholangiocarcinoma
Other: Observation data collection study.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2005
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with unresectable 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301379

Contacts
Contact: William Chapman, MD 314-362-7792 chapmanw@wudosis.wustl.edu
Contact: Casey Rowe, MS, BS 314-362-8547 rowec@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: William Chapman, MD    314-362-7792    chapmanw@wudosis.wustl.edu   
Contact: Casey Rowe, MS, BS    314-362-8547    rowec@wudosis.wustl.edu   
Principal Investigator: William C. Chapman, M.D.         
Sub-Investigator: Joel Picus, M.D.         
Sub-Investigator: Surendra Shenoy, MD         
Sub-Investigator: Jeffrey Lowell, MD         
Sub-Investigator: Jeffrey Crippin, MD         
Sub-Investigator: Mauricio Lisker-Mehlman, MD         
Sub-Investigator: Kevin Korenblat, MD         
Sub-Investigator: Riad Azar, MD         
Sub-Investigator: Benjamin Tan, MD         
Sub-Investigator: Steven Edmundowicz, MD         
Sub-Investigator: Sreenivasa Jonnalagadda, MD         
Sub-Investigator: Parag Parikh, M.D.         
Sub-Investigator: Elizabeth Brunt, M.D.         
Sub-Investigator: Steven Sorscher, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: William C. Chapman, M.D. Washington University Early Recognition Center
  More Information

Additional Information:
Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00301379     History of Changes
Other Study ID Numbers: 05-0651 / 201102096
Study First Received: March 8, 2006
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Cholangiocarcinoma
Observational

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014