Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

Cholangiocarcinoma Clinical Trial

Official title:

Prospective Registry Study of Neoadjuvant Therapy in Conjunction With Liver Transplantation for Cholangiocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00301379
• Other study ID #: 05-0651 / 201102096
• Status: Terminated
• Start date: August 12, 2005
• Est. completion date: June 6, 2023

Study information

• Verified date: June 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

4. Listed for OLT for hilar cholangiocarcinoma

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Picus, Proc ASCO, 13:208, 1994.

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. — View Citation

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. — View Citation

Tsavaris, Inv New Drugs, 22:193, 2004;Verdarame, Anti-Cancer Drugs, 11:707,2000.

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients withdrawn due to toxicity and other treatment related events.		Completion of treatment for all patients (estimated to be 18 years total)
Secondary	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)
Secondary	Overall survival		Completion of treatment for all patients (estimated to be 18 years total)
Secondary	Disease-free survival		Completion of treatment for all patients (estimated to be 18 years total)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine