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Low accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with unresectable cholangiocarcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation data collection study. | Other | This is a data collection study where the main purpose is to collect information about the treatments patients receive for their unresectable cholangiocarcinoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients withdrawn due to toxicity and other treatment related events. | Completion of treatment for all patients (estimated to be 18 years total) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who respond to treatment | -Response is defined as an absence of progressive disease or metastasis, so that the patient remains a candidate for liver transplantation | Completion of treatment for all patients (estimated to be 18 years total) |
| Overall survival |
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Inclusion Criteria:
Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria:
Tumor/stricture is above the cystic duct and is unresectable.
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.
>/= 18 years of age.
Willing and able to provide written informed consent.
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Primary care clinic.
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| Name | Affiliation | Role |
|---|---|---|
| William C. Chapman, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15382214 | Background | 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. doi: 10.1002/lt.20266. | |
| 11573044 | Background | 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. doi: 10.1097/00000658-200110000-00010. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Completion of treatment for all patients (estimated to be 18 years total) |
| Disease-free survival | Completion of treatment for all patients (estimated to be 18 years total) |
| 9358085 | Background | 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. doi: 10.1016/s1072-7515(97)00088-4. |
| 10827231 | Background | 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. doi: 10.1053/lv.2000.6143. |
| 15094230 | Background | Brandsaeter B, Isoniemi H, Broome U, Olausson M, Backman L, Hansen B, Schrumpf E, Oksanen A, Ericzon BG, Hockerstedt K, Makisalo H, Kirkegaard P, Friman S, Bjoro K. Liver transplantation for primary sclerosing cholangitis; predictors and consequences of hepatobiliary malignancy. J Hepatol. 2004 May;40(5):815-22. doi: 10.1016/j.jhep.2004.01.002. |
| 9445113 | Background | 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. doi: 10.1097/00000658-199801000-00011. |
| 11753904 | Background | 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. doi: 10.1053/jlts.2001.29419. |
| 8273866 | Background | 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. doi: 10.1016/s0002-9610(05)80696-8. |
| 12607579 | Background | 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. doi: 10.1016/s1055-3207(02)00036-4. |
| 12243499 | Background | 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. doi: 10.1034/j.1600-6143.2002.20812.x. |
| Background | Tsavaris, Inv New Drugs, 22:193, 2004;Verdarame, Anti-Cancer Drugs, 11:707,2000. |
| Background | Picus, Proc ASCO, 13:208, 1994. |
| 8707097 | Background | Broome U, Olsson R, Loof L, Bodemar G, Hultcrantz R, Danielsson A, Prytz H, Sandberg-Gertzen 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. doi: 10.1136/gut.38.4.610. |
| Background | 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 |
| 20662793 | Background | 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. |
| 16969352 | Background | 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. doi: 10.1038/sj.bjc.6603334. Epub 2006 Sep 12. |
| D009369 | Neoplasms |