Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

The Washington University

Status: Terminated

Conditions: Cholangiocarcinoma

Treatments: Other: Observation data collection study.

Study type: Observational

Funder types: Other

Identifiers

NCT00301379

05-0651 / 201102096

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

59 participants in 1 patient group

1

Description:

Patients with unresectable cholangiocarcinoma.

Treatment:

Other: Observation data collection study.