Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/25/2018 |
| Start Date: | August 12, 2005 |
| End Date: | December 31, 2022 |
| Contact: | William Chapman, MD |
| Email: | chapmanwc@wustl.edu |
| Phone: | 314-362-7792 |
Prospective Registry Study of Neoadjuvant Chemoradiation in Conjunction With Liver Transplantation for Cholangiocarcinoma With Induction Gemcitabine, Followed by 3D Conformal Radiation With 5-FU as a Radiosensitizer, and Maintenance Xeloda Therapy Until Liver Transplantation
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.
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.
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.
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.
Exclusion Criteria:
1. Intrahepatic metastasis or other metastatic disease (except peri-hilar nodes).
2. Prior treatment for this disease (including attempts at resection, irradiation, or
chemotherapy)
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: William C. Chapman, M.D.
Phone: 314-362-7792
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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