Cholangiocarcinoma
Conditions
Keywords
Cholangiocarcinoma, Observational
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.
Interventions
OTHERObservation 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.
Sponsors
Washington University School of Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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| Proportion of patients withdrawn due to toxicity and other treatment related events.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
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | Completion of treatment for all patients (estimated to be 18 years total) | — |
| Proportion of patients who respond to treatment | Completion of treatment for all patients (estimated to be 18 years total) | -Response is defined as an absence of progressive disease or metastasis, so that the patient remains a candidate for liver transplantation |
| Overall survival | Completion of treatment for all patients (estimated to be 18 years total) | — |
Countries
United States
Outcome results
None listed