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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT00350961
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven intra- or extrahepatic cholangiocarcinoma, papilla of the Vater or gallbladder carcinoma.
* PS 0-2
* Age 18-75
* Life expectancy \> 12 weeks
* Normal bone marrow function (neutrophiles \> 1,5 x 109/l and platelets \> 100 x 109/l)
* Bilirubin \< 1,5 x UNL
* Transaminases \< 3 x UNL
* Normal renal function, Cr-EDTA clearance \> 50 ml/min
* No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
* No known DPD-deficiency
* No neuropathy
* No uncontrolled, severe concurrent medical disease
* Signed informed consent
Exclusion Criteria:
* Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
* Experimental therapy \< 8 weeks prior to inclusion
* Uncontrolled, severe concurrent medical disease
* Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
* Allergy to gemcitabine, oxaliplatin or capecitabine
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00350961
Study Brief:
Protocol Section:
NCT00350961