Status:
UNKNOWN
International Registry on Cholangiocarcinoma Treatment
Lead Sponsor:
International Group of Endovascular Oncology
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Brief Summary
Cholangiocarcinoma is a rare and very aggressive neoplasm that arises from the biliary epithelium, constitutes approximately 2% of all reported cancer, and accounts for about 3% of all gastrointestina...
Detailed Description
Study Design: Prospective observational study Primary objective: This is a data collection study where the main purpose is to collect information about the treatments that patients receive for their ...
Eligibility Criteria
Inclusion
- The diagnosis of cholangiocarcinoma will be established preoperatively by at least one of the following criteria: a) positive brush cytology or biopsy result obtained at the time of cholangiography; b) Fluorescence in situ hybridization demonstrating aneuploidy; c) serum CA 19-9 value greater than 100 U/mL in the presence of a radiographically characteristic malignant stricture in the absence of cholangitis.
- Tumor is above the cystic duct and is unresectable.
- Patient is a suitable candidate for the study by a radiation oncologist, a medical oncologist, and the liver surgeon
- Maximum Eastern Cooperative Oncology Group performance status of 2 and a minimum daily caloric intake of 1200kcal.
- No evidence of metastatic disease.
- Between ages 18 - 75.
- Patient must provide written informed consent.
Exclusion
- Patients with intrahepatic metastasis presenting liver involvement more than 75%
- Patients with uncontrolled infections (sepsis)
- Evidence of extrahepatic disease, including local lymph node metastasis (except peri-hilar nodes).
- History of another malignancy diagnosed within 5 years, excluding "in situ" skin and cervical cancers, without metastases.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01920503
Start Date
July 1 2013
End Date
August 1 2020
Last Update
February 27 2019
Active Locations (1)
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1
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, Italy, 61122