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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01954732
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed resectable pancreatic carcinoma; patients with pancreatic neuroendocrine tumors are not eligible
* Patients must be previously untreated with chemotherapy or radiation therapy
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Patients must have surgical resection of the pancreas planned, with enrollment at least 7 days prior to surgery; patients with surgery scheduled \> 15 days will not be excluded
* Hemoglobin (Hg)A1C must be below 7%
* Total bilirubin less than 1.5 X institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 X institutional upper limit of normal
* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
* Serum creatinine within normal institutional limits
* Alkaline phosphatase \< 1.5 X institutional upper limit of normal
* Subjects must have the ability to understand and be willing to provide written informed consent
Exclusion Criteria:
* History of metformin use in the previous 3 months
* Treatment with neoadjuvant chemotherapy or radiation therapy
* History of allergic reactions attributed to metformin
* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Metabolic acidosis, acute or chronic, including ketoacidosis
* Metastatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01954732
Study Brief:
Protocol Section:
NCT01954732