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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02022033
Eligibility Criteria:
Inclusion Criteria:
* Histologic proof of primary pancreas invasive adenocarcinoma or adenosquamous cancer, managed with a potentially curative resection (i.e., removal of all gross tumor). Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible.
* Interval between definitive tumor-related surgery and registration between 21-70 days.
* Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible.
* Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study.
* Preexisting neuropathy \< grade 1 (per CTCAE).
* ECOG performance status 0 or 1.
* Age ≥ 18
* Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause of lack of menses \>12 months) do not need to have a pregnancy test, please document status.
* Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
* Required Initial Laboratory Values:
* Neutrophils ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
* Total bilirubin ≤ 1.5 x ULN
* AST (SGOT) \& ALT (SGPT) ≤ 2.5 x ULN
* Alkaline phosphatases \< 2.5x ULN
* Abdominal CT scan with contrast and chest CT/x-ray (CT of chest preferred) within 6 weeks of registration on study. Patients can have PET/MRI of the chest/abdomen instead.
Exclusion Criteria:
* Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
* Prior hypersensitivity to Oxaliplatin or Abraxane that in the investigators opinion would put the patient at risk if re-exposed
* Patients with islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.
* Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable. Patients must not have received chemotherapy for a year prior to registering on study
* No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible. This must be documented.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02022033
Study Brief:
Protocol Section:
NCT02022033