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Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients
This study is currently recruiting participants.
Verified by Washington University School of Medicine, August 2008
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00301379
  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.

MedlinePlus related topics: Liver Transplantation
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Capecitabine Fluorouracil
U.S. FDA Resources
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

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Contacts
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

Locations
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            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: William C. Chapman, M.D. Washington University School of Medicine
  More Information

Publications:
Heimbach JK, Haddock MG, Alberts SR, Nyberg SL, Ishitani MB, Rosen CB, Gores GJ. Transplantation for hilar cholangiocarcinoma. Liver Transpl. 2004 Oct;10(10 Suppl 2):S65-8. Review.
Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9.
Casavilla FA, Marsh JW, Iwatsuki S, Todo S, Lee RG, Madariaga JR, Pinna A, Dvorchik I, Fung JJ, Starzl TE. Hepatic resection and transplantation for peripheral cholangiocarcinoma. J Am Coll Surg. 1997 Nov;185(5):429-36.
De Vreede I, Steers JL, Burch PA, Rosen CB, Gunderson LL, Haddock MG, Burgart L, Gores GJ. Prolonged disease-free survival after orthotopic liver transplantation plus adjuvant chemoirradiation for cholangiocarcinoma. Liver Transpl. 2000 May;6(3):309-16.
Brandsaeter B, Isoniemi H, Broomé U, Olausson M, Bäckman L, Hansen B, Schrumpf E, Oksanen A, Ericzon BG, Höckerstedt K, Mäkisalo H, Kirkegaard P, Friman S, Bjøro K. Liver transplantation for primary sclerosing cholangitis; predictors and consequences of hepatobiliary malignancy. J Hepatol. 2004 May;40(5):815-22.
Madariaga JR, Iwatsuki S, Todo S, Lee RG, Irish W, Starzl TE. Liver resection for hilar and peripheral cholangiocarcinomas: a study of 62 cases. Ann Surg. 1998 Jan;227(1):70-9.
Shimoda M, Farmer DG, Colquhoun SD, Rosove M, Ghobrial RM, Yersiz H, Chen P, Busuttil RW. Liver transplantation for cholangiocellular carcinoma: analysis of a single-center experience and review of the literature. Liver Transpl. 2001 Dec;7(12):1023-33. Review.
Goldstein RM, Stone M, Tillery GW, Senzer N, Levy M, Husberg BS, Gonwa T, Klintmalm G. Is liver transplantation indicated for cholangiocarcinoma? Am J Surg. 1993 Dec;166(6):768-71; discussion 771-2.
Hassoun Z, Gores GJ, Rosen CB. Preliminary experience with liver transplantation in selected patients with unresectable hilar cholangiocarcinoma. Surg Oncol Clin N Am. 2002 Oct;11(4):909-21.
Sudan D, DeRoover A, Chinnakotla S, Fox I, Shaw B Jr, McCashland T, Sorrell M, Tempero M, Langnas A. Radiochemotherapy and transplantation allow long-term survival for nonresectable hilar cholangiocarcinoma. Am J Transplant. 2002 Sep;2(8):774-9.
Broomé U, Olsson R, Lööf L, Bodemar G, Hultcrantz R, Danielsson A, Prytz H, Sandberg-Gertzén H, Wallerstedt S, Lindberg G. Natural history and prognostic factors in 305 Swedish patients with primary sclerosing cholangitis. Gut. 1996 Apr;38(4):610-5.

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

Keywords provided by Washington University School of Medicine:
Cholangiocarcinoma
Observational

Study placed in the following topic categories:
Cholangiocarcinoma
Capecitabine
Fluorouracil
Gemcitabine
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009