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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01032057
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced, nonmetastatic, inoperable, or operable (but medically unfit for surgery) disease
* Palliative bypass procedure allowed
* Common bile duct stenting allowed
* Primary pancreatic lesion ≤ 7 cm in diameter as measured by CT scan of the thorax and abdomen within 4 weeks prior to registration
* No recurrent cancer following definitive pancreatic surgery
PATIENT CHARACTERISTICS:
* WHO performance status (PS) 0-2
* Neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Hemoglobin ≥ 10 g/dL
* Serum bilirubin \< 35 μmol/L (50 μmol/L allowed for patients who have had a recent biliary drain and whose bilirubin is descending)
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times ULN
* GFR \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 weeks after completion of study therapy
* No evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease
* No myocardial infarction or stroke within the past 6 months
* No prior malignancies within the past 5 years except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, or any early-stage malignancy
* No suspected DPD deficiency
* No renal abnormalities (e.g., adult polycystic kidney disease, hydronephrosis, or ipsilateral single kidney)
* Must meet the following additional criteria for randomization:
* WHO PS 0-1
* Loss of weight no greater than 10% of that at baseline
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior and no concurrent sorivudine or analogues
* No prior radiotherapy to the upper abdomen
* No concurrent methotrexate
* No concurrent allopurinol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01032057
Study Brief:
Protocol Section:
NCT01032057