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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT00878657
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas, ampulla of Vater, or distal bile duct
* Locally advanced disease
* Medically inoperable, unresectable, or borderline resectable disease
* No previously resected disease (i.e., status post-pancreaticoduodenotomy)
* No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma, cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma
* No lesions in the tail of the pancreas and/or splenic artery/vein involvement/encasement
* No recurrent or metastatic (M1) disease
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* WBC \> 3,000/μL
* Platelet count \> 100,000/μL
* Bilirubin ≤ 2 mg/dL
* SGOT \< 5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and ≤ 5% weight loss)
* No active malignancy within the past 3 years, except cervical carcinoma in situ or nonmelanoma skin cancer that has been removed
* No severe, active comorbidity, including any of the following:
* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* Transmural myocardial infarction within the past 6 months
* Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within the past month or precluding study therapy at the time of study registration
* Active hepatitis, decompensated cirrhosis, or clinically significant liver failure
* Other severe comorbid condition, as determined by the principal investigator
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy
* No prior radiotherapy to any upper abdominal site
* No concurrent prophylactic colony-stimulating factors during radiotherapy
* No concurrent warfarin
* No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00878657
Study Brief:
Protocol Section:
NCT00878657