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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT00010166
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive adenocarcinoma of the pancreas
* Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months
* No clinical evidence of gross residual disease at time of surgery
* No focally positive margins (tumor at the margin)
* No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-2
Life expectancy:
* More than 6 months
Hematopoietic:
* Granulocyte count greater than 1,500/mm3
* Hemoglobin greater than 10 g/dL
* Platelet count greater than 100,000/mm3
Hepatic:
* Bilirubin less than 2.0 mg/dL
Renal:
* Creatinine less than 2.0 mg/dL
Other:
* Able to maintain adequate oral nutrition
* Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study
* No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
* Non-metastatic prostate cancer allowed if more than 2 year survival likely
* No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent routine growth factors
Chemotherapy:
* No prior chemotherapy for pancreatic cancer
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior abdominal radiotherapy for pancreatic cancer
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00010166
Study Brief:
Protocol Section:
NCT00010166