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Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

This study is currently recruiting participants.
Verified May 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301379
First Posted: March 10, 2006
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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:
  • Proportion of patients withdrawn due to toxicity and other treatment related events. [ Time Frame: Completion of treatment for all patients (estimated to be 13 years total) ]

Secondary Outcome Measures:
  • Proportion of patients who respond to treatment [ Time Frame: 2 years ]
    -Response is defined as an absence of progressive disease or metastasis, so that the patient remains a candidate for liver transplantation

  • Overall survival [ Time Frame: 2 years ]
  • Disease-free survival [ Time Frame: 2 years ]

Estimated Enrollment: 30
Study Start Date: August 2005
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Criteria

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 the liver transplant team. All 3 treatment modalities are not needed to confirm eligibility for this registry trial.
  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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301379


Contacts
Contact: William Chapman, MD 314-362-7792 chapmanwc@wustl.edu
Contact: Tracey Guthrie 314-747-4404 guthriet@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: William Chapman, MD    314-362-7792    chapmanwc@wustl.edu   
Contact: Tracey Guthrie    314-747-4404    guthriet@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: 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
Investigators
Principal Investigator: William C. Chapman, M.D. Washington University School of Medicine
  More Information

Additional 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.
Tsavaris, Inv New Drugs, 22:193, 2004;Verdarame, Anti-Cancer Drugs, 11:707,2000.
Picus, Proc ASCO, 13:208, 1994.
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.
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
Williams KJ, Picus J, Trinkhaus K, Fournier CC, Suresh R, James JS, Tan BR. Gemcitabine with carboplatin for advanced biliary tract cancers: a phase II single institution study. HPB (Oxford). 2010 Aug;12(6):418-26. doi: 10.1111/j.1477-2574.2010.00197.x.
Harder J, Riecken B, Kummer O, Lohrmann C, Otto F, Usadel H, Geissler M, Opitz O, Henss H. Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. Br J Cancer. 2006 Oct 9;95(7):848-52. Epub 2006 Sep 12.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00301379     History of Changes
Other Study ID Numbers: 05-0651 / 201102096
First Submitted: March 8, 2006
First Posted: March 10, 2006
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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


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