Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients with Pancreatic Cancer

Pre-Registration Eligibility Criteria

• Documentation of Disease and Radiographic Staging

  • Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process
  • Objective radiographic staging with a) contrast-enhanced, helical thin-cut computed tomography (CT)/magnetic resonance imaging (MRI) scan of the abdomen and b) CT scan/MRI of the chest
  • Note: echoendoscopic staging will be permitted as an adjunctive modality, but all stage definitions below will be determined using CT/MRI as outlined below. In the event echoendoscopic stage and CT/MRI stage are discordant, the CT/MRI stage will be used. Significant discordance should be discussed with the study principal investigator (PI) prior to enrollment

  • Borderline resectable primary tumor, defined by the presence of any one or more of the following on CT/MRI, and confirmed by central radiographic review:

    • An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring ≥ 180 degrees of the circumference of the vessel wall
    • Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
    • Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction
    • An interface between the tumor and superior mesenteric artery (SMA) measuring \< 180 degrees of the circumference of the vessel wall

  • No potentially resectable disease defined as primary tumors with all of the following:

    • An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring \< 180 degrees of the circumference of the vessel wall
    • No radiographic interface between the tumor and the (superior mesenteric artery) SMA, hepatic artery or celiac axis
    • No radiographic evidence of metastatic disease

  • No metastatic disease defined as any one or more of the following:

    • Suspicious lymphadenopathy outside the standard surgical field (i.e., aortocaval nodes, distant abdominal nodes)
    • Radiographic evidence for metastatic disease in distant organs, such as masses in distant organs or ascites

  • No locally advanced and/or unresectable disease clearly defined by any one or more of the following by CT/MRI:

    • An interface between the tumor and the SMA measuring ≥ 180 degrees of the circumference of the vessel wall
    • No interface between the tumor and the aorta
    • Occlusion of the SMV or portal vein without a sufficient cuff of normal vein above and below the level of obstruction with which to perform venous reconstruction
    • Long-segment interface (of any degree) between the tumor and the common hepatic artery or its major tributaries with insufficient artery proximal and distal to the interface to perform reconstruction
• No prior chemotherapy or chemoradiation for pancreatic cancer
• No patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years
• Baseline peripheral sensory neuropathy must be grade \< 2
• No patients with known Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism
• No history of pulmonary embolism in the past 6 months
• Age ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0-1
• Pregnancy/Nursing Status: Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic > 12 months to be considered not of childbearing potential.

• Required Pre-Registration Laboratory Values:

  • Granulocytes ≥ 2,000/ul
  • Hemoglobin > 9 g/dL
  • Platelets ≥ 100,000/ul
  • Albumin > 3.0 g/dL
  • Creatinine ≤1.5 x upper limit of normal (ULN)

Registration Eligibility Criteria

• Confirmation of pre-registration eligibility criteria as described under "Documentation of Disease and Radiographic Staging" by the Alliance Central Radiographic Review

• Required Registration Laboratory Values:

  • Bilirubin ≤2 mg/dl
  • AST (SGOT) \& ALT (SGPT) ≤ 2.5 x ULN