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

Washington University School of Medicine1 site in 1 country59 target enrollmentAugust 12, 2005

ConditionsCholangiocarcinoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cholangiocarcinoma
Sponsor: Washington University School of Medicine
Enrollment: 59
Locations: 1
Primary Endpoint: Proportion of patients withdrawn due to toxicity and other treatment related events.
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 12, 2005

End Date

June 6, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

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.

Exclusion Criteria

Not provided

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Proportion of patients withdrawn due to toxicity and other treatment related events.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