Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Other: Observation data collection study.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria: A positive brush cytology or biopsy result obtained at the time of cholangiography; Fluorescence in situ hybridization demonstrating aneuploidy; 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. Listed for OLT for hilar cholangiocarcinoma 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with unresectable cholangiocarcinoma. | Other: Observation data collection study.<br>* This is a data collection study where the main purpose is to collect information about the treatments patients receive for their unresectable cholangiocarcinoma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, Observational