Neoadjuvant Gemcitabine, Oxaliplatin, and Radiation Therapy for Pancreatic Cancer

Inclusion Criteria:

• Determination of resectability is based on spiral CT with both oral and intravenous contrast enhancement. The patient's tumor is considered resectable if there are no distant metastases, a clear fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric vein/portal vein.
• Patients considered borderline resectable per the NCCN criteria include patients with severe unilateral SMV/portal impingement, tumor abutment on the SMA, GDA encasement up to the origin at the hepatic artery, or colon invasion.

Note: Prior to treatment initiation, patients will be coded as resectable or borderline resectable.

Eligibility Criteria:

• Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas. Patients with neuroendocrine tumors are excluded.
• Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
• Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of < 2.
• Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
• Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
• Patients with preexisting peripheral neuropathy > grade 2 are ineligible.
• Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.
• Patients must be aware of the investigational nature of the therapy and provide written informed consent.
• Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
• Patients must not have used any investigational agent in the month before enrollment into the study.
• Pretreatment Evaluation
• Complete history and physical examination including weight and Zubrod performance status to be completed within 2 weeks of registration.
• CBC with differential, platelets, serum chemistry panel (to include albumin, alkaline phosphatase, ALT or AST, glucose, total bilirubin, creatinine, BUN, electrolytes), and CEA/CA 19-9 within 2 weeks of registration.
• Diagnostic helical CT of the abdomen with oral and intravenous contrast to be completed within 4 weeks of registration. Patients in whom IV contrast is contraindicated based on severe allergy or decreased renal function should have an MRI scan of the abdomen.
• Diagnostic helical CT scan of the chest.
• FDG-PET/CT scan within 4 weeks of registration, if available. (This is not required but desired.)