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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT01446458
Eligibility Criteria:
Inclusion Criteria: Patients eligible must have:
* Histologic or cytologic diagnosis of pancreatic adenocarcinoma.
* Radiographically resectable or borderline resectable disease as reviewed by an experienced surgical oncologist at Emory.
* Age 21 years or older.
* Not received prior chemotherapy or radiation for pancreatic cancer.
* ECOG performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Adequate bone marrow function: absolute neutrophil count \> 1,500/cmm, platelet count \> 100,000/cmm.
* Understanding and be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
Exclusion Criteria: Patients who are not eligible have
* Histologies including endocrine tumors or lymphoma of the pancreas.
* A tumor which is less than 3 mm from the duodenum as measured by either CT or MRI.
* History of central nervous system (CNS) metastases.
* Liver dysfunction, including total bilirubin \> 1.5 mg/dL; aspartate transaminase (AST) and alanine amino transferase (ALT) \> 5 times upper limit of the institutional normal.
* Creatinine ≥ 1.5 mg/dL.
* Albumin ≤ 2.5 g/dL.
* International Normalized Ratio (INR) ≥ 1.5 (in the absence of ongoing treatment with warfarin).
* Breast feeding.
* Serious active infection.
* Serious concurrent systemic disorders incompatible with participating in the study (at the discretion of the investigator).
* An active second primary malignancy (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study.
* Clinical evidence of distant metastatic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01446458
Study Brief:
Protocol Section:
NCT01446458