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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00524069
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Resectable disease (i.e., stage I or II disease)
* No unresectable (i.e., locally advanced) disease
* No tumor invasion into the stomach or duodenum
* No CNS, brain, or systemic metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* WBC \> 3,000/μL
* ANC \> 1,500/μL
* Platelet count \> 100,000/μL
* Total bilirubin \< 2 mg/dL
* AST or ALT \< 2.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 mg/dL
* Creatinine clearance ≥ 50 mL/min
* Urine protein:creatinine ratio \< 1.0
* Hemoglobin ≥ 9 g/dL (transfusion, epoetin alfa, or darbepoetin allowed)
* INR \< 1.5 times ULN (except in patients receiving full-dose warfarin)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled hypertension
* No unstable angina
* No New York Heart Association class II-IV congestive heart failure
* No myocardial infarction or stroke within the past 6 months
* No clinically significant peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No significant traumatic injury within the past 28 days
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No esophageal or gastric varices
* No serious nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
* No prior therapy for pancreatic cancer
* More than 4 weeks since prior and no concurrent participation in another experimental drug study
* More than 28 days since prior major surgical procedure or open biopsy
* More than 7 days since prior minor surgical procedure (e.g., fine-needle aspiration or core biopsy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00524069
Study Brief:
Protocol Section:
NCT00524069