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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00301379 |
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 |
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Cholangiocarcinoma |
Other: Observation data collection study. |
Study Type: | Observational |
Study Design: | Case-Only, 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 |
Estimated Enrollment: | 20 |
Study Start Date: | November 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 |
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1
Patients with unresectable cholangiocarcinoma.
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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.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Primary care clinic.
Inclusion Criteria:
The diagnosis of cholangiocarcinoma will be established preoperatively by at least one of the following criteria:
Exclusion Criteria:
Contact: Debra Kemp, R.N., B.S.N. | 314-362-3791 | kempd@msnotes.wustl.edu |
Contact: Mary Ann Laflin, RN | 314-454-5960 | laflinm@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Debra Kemp, RN, BSN 314-362-3791 kempd@wustl.edu | |
Contact: Mary Ann Laflin, RN 314-454-5960 laflinm@wustl.edu | |
Principal Investigator: William C. Chapman, M.D. | |
Sub-Investigator: Robert Myerson, M.D., Ph.D. | |
Sub-Investigator: Joel Picus, M.D. | |
Sub-Investigator: Surendra Shenoy, MD | |
Sub-Investigator: Jeffrey Lowell, MD | |
Sub-Investigator: Niraj Desai, 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: Hanlin Wang, MD |
Principal Investigator: | William C. Chapman, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( William Chapman, MD ) |
Study ID Numbers: | 05-0651 |
Study First Received: | March 8, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00301379 |
Health Authority: | United States: Institutional Review Board |
Cholangiocarcinoma Observational |
Cholangiocarcinoma Capecitabine Fluorouracil Gemcitabine |
Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type |