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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00440167
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years
* Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1)
* No option for resection with curative intent
* At least one measurable or not measurable lesion (according to RECIST)
* No previous chemotherapy or other systemic tumor therapy
* No previous radiation
* Performance-Status 0-2 according to WHO/ECOG
* Life expectancy of at least 3 months
* Adequate kidney-, liver- and bone marrow function, defined as
* Absolute neutrophil count \* 1,5 x 109/l
* Hemoglobin \* 8 g/dl
* Thrombocytes \* 100 x 109/l
* Bilirubin \* 2 x upper norm (with liver mets \< 5-fold)
* Serum Creatinine \* 1,25 x upper norm
* Creatinine clearance \> 30 ml/min (Cockroft/Gault)
* Transaminases \* 2,5 x upper norm (with liver mets \< 5-fold)
* Possibility of regular long-term follow-up
* Negative pregnancy test in women at childbearing age
* All patients must have signed an informed consent before study entry.
Exclusion Criteria:
* Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri
* Clinically unstable CNS-metastases
* Known hypersensitivity against study medication
* Severe impairment of renal function (creatinine clearance \< 30 ml/min)
* Severe impairment of liver function (bilirubin \> 2,0 x above upper norm, transaminases \> 2,5 x upper norm, or with known liver metastasis \>5 x upper norm)
* Clinically relevant disease of the cardiovascular system or other vital organs
* Known polyneuropathy
* Known DPD-deficiency (screening not required)
* Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin
* Pregnancy, lactation or lack of reliable contraception in women at childbearing age
* Mental disease, drug- or alcohol abuse
* Participation in another clinical trial within the last 4 weeks
* All other diseases which may prevent adequate participation in the trial
* Indication of lack of compliance with study regulations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00440167
Study Brief:
Protocol Section:
NCT00440167