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Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: March 8, 2006
Last updated: January 18, 2017
Last verified: January 2017
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
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  • Primary (Phase I): Proportion of patients withdrawn due to toxicity and other treatment related events. [ Time Frame: Approximately 5 years. ]
  • Primary (Phase II): 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: Approximately 5 years. ]

Estimated Enrollment: 30
Study Start Date: August 2005
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic.

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 a radiation oncologist, a medical oncologist, and the liver transplant team.
  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)
  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 identifier: NCT00301379

Contact: William Chapman, MD 314-362-7792
Contact: Tracey Guthrie 314-747-4404

United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: William Chapman, MD    314-362-7792   
Contact: Tracey Guthrie    314-747-4404   
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: Benjamin Tan, MD         
Sub-Investigator: Parag Parikh, M.D.         
Sub-Investigator: Elizabeth Brunt, M.D.         
Sub-Investigator: M.B. Majella Doyle, M.D.         
Sub-Investigator: Kathryn Fowler, M.D.         
Sub-Investigator: Vamsi Narra, M.D.         
Sub-Investigator: Nael Saad, M.D.         
Sub-Investigator: Daniel Mullady, M.D.         
Sub-Investigator: Jaquelyn Fleckenstein, M.D.         
Sub-Investigator: Jason Wellen, M.D.         
Sub-Investigator: Yiing Lin, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: William C. Chapman, M.D. Washington University School of Medicine
  More Information

Additional Information:
Tsavaris, Inv New Drugs, 22:193, 2004;Verdarame, Anti-Cancer Drugs, 11:707,2000.
Picus, Proc ASCO, 13:208, 1994.
Valle JW WH, Palmer DD, Cunningham D, Anthoney DA, Maraveyas A, Hughes SK, Roughton JA, Bridgewater JA: Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial). J Clin Oncol 27:15s, 2009 (suppl, abstr 4503), 2009

Responsible Party: Washington University School of Medicine Identifier: NCT00301379     History of Changes
Other Study ID Numbers: 05-0651 / 201102096 
Study First Received: March 8, 2006
Last Updated: January 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms processed this record on February 17, 2017