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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT00599833
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histopathologically or cytologically confirmed diagnosis of inoperable, non-metastatic, locally advanced pancreatic adenocarcinoma
* No neuroendocrine tumors or lymphoma of the pancreas
* No extensive disease unable to be covered in a radically treatable radiotherapy volume
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy \> 3 months
* Hemoglobin ≥ 10g/dL
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³ (prior transfusions for patients with low hemoglobin allowed)
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 1.5 times ULN
* Serum urea ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Adequate biliary drainage with no evidence of active uncontrolled infection (patients on prophylactic antibiotics are eligible)
* Not pregnant or nursing
* Negative pregnancy test
* Women and men of child-bearing potential should be using an adequate contraception method, which must be continued for 3 months after completion of therapy
* No unresolved biliary tract obstruction
* No history of prior malignancy that may interfere with the response evaluation except for any of the following:
* Cervical carcinoma in-situ treated by cone-biopsy/resection
* Nonmetastatic basal and/or squamous cell carcinomas of the skin
* Any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously
* No relative contraindication to radiotherapy
* No evidence of severe uncontrolled systemic diseases or laboratory finding that in the view of investigator makes it undesirable for the patient to participate in the trial
* No disorder likely to impact compliance with the protocol
PRIOR CONCURRENT THERAPY:
* Must be completely recovered from previous surgery
* The following prior interventions are allowed:
* Non-curative operation (i.e., R2 resection with macroscopic residual disease evident on CT scan or palliative bypass procedure)
* Stent insertion in the common bile duct
* No previous radiotherapy within current treatment field
* No previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00599833
Study Brief:
Protocol Section:
NCT00599833