Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

Washington University School of Medicine59 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cholangiocarcinoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Proportion of patients withdrawn due to toxicity and other treatment related events.

Time frame: Completion of treatment for all patients (estimated to be 18 years total)

Secondary Outcomes

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

Time frame: Completion of treatment for all patients (estimated to be 18 years total)

Overall survival

Time frame: Completion of treatment for all patients (estimated to be 18 years total)

Disease-free survival

Time frame: Completion of treatment for all patients (estimated to be 18 years total)

Data from ClinicalTrials.gov

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