Clinical Trial: Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Prospective Registry Study of Neoadjuvant Chemoradiation in Conjunction With Liver Transplantation for Cholangiocarcinoma With Induction Gemcitabine, Followed by 3D Confor
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.
Detailed Summary:
Sponsor: Washington University School of Medicine
Current Primary Outcome: Proportion of patients withdrawn due to toxicity and other treatment related events. [ Time Frame: Completion of treatment for all patients (estimated to be 13 years total) ]
Original Primary Outcome:
Current Secondary Outcome:
- Proportion of patients who respond to treatment [ Time Frame: 2 years ]-Response is defined as an absence of progressive disease or metastasis, so that the patient remains a candidate for liver transplantation
- Overall survival [ Time Frame: 2 years ]
- Disease-free survival [ Time Frame: 2 years ]
Original Secondary Outcome:
Information By: Washington University School of Medicine
Dates:
Date Received: March 8, 2006
Date Started: August 2005
Date Completion: December 31, 2019
Last Updated: May 3, 2017
Last Verified: May 2017
