Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01920503
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. Tumor is above the cystic duct and is unresectable.
3. Patient is a suitable candidate for the study by a radiation oncologist, a medical oncologist, and the liver surgeon
4. Maximum Eastern Cooperative Oncology Group performance status of 2 and a minimum daily caloric intake of 1200kcal.
5. No evidence of metastatic disease.
6. Between ages 18 - 75.
7. Patient must provide written informed consent.
Exclusion Criteria:
1. Patients with intrahepatic metastasis presenting liver involvement more than 75%
2. Patients with uncontrolled infections (sepsis)
3. Evidence of extrahepatic disease, including local lymph node metastasis (except peri-hilar nodes).
4. History of another malignancy diagnosed within 5 years, excluding "in situ" skin and cervical cancers, without metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01920503
Study Brief:
Protocol Section:
NCT01920503