Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer

DISEASE CHARACTERISTICS:

• Pathologically confirmed localized adenocarcinoma of the pancreas or distal common bile duct

  • Pancreatic ductal adenocarcinoma or peripancreatic cholangiocarcinoma

• Resectable disease, as determined by the Gastrointestinal Cancer Working Group disease-oriented team

  • Criteria used to define unresectability will include, but not be limited to, the following:

    • Tumor encases > 180 degrees of the circumference of the superior mesenteric artery
    • Tumor encases the common hepatic artery with no anatomic option for reconstruction following segmental resection
    • Superior mesenteric vein occluded or encased with no option for reconstruction following segmental resection
    • Soft tissue infiltration of the retroperitoneum to the left of the superior mesenteric artery
• All malignant disease must be encompassed within a single radiotherapy field
• No metastatic disease

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• Absolute granulocyte count > 1,500/mm³
• Platelet count > 100,000/mm³
• Creatinine clearance > 50mL/min
• AST and ALT < 5 times upper limit of normal
• Serum bilirubin < 5 mg/dL (with biliary decompression)
• INR ≤ 1.5
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Medically fit for pancreatic surgical resection, as determined by the investigating surgeons at the time of study enrollment
• No evidence of an active second invasive malignancy outside the area of the pancreas or biliary system within the past 2 years, except for non-melanomatous skin cancer or carcinoma in situ of the breast, bladder, cervix, or uterus

• No clinically significant cardiac disease, including the following:

  • Uncontrolled hypertension, defined as blood pressure > 160/90 mm Hg on medication
  • Myocardial infarction within the past 6 months
  • NYHA class II-IV congestive heart failure

  • Unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [atrial fibrillation or paroxysmal supraventricular tachycardia])

    • Atrial arrhythmia allowed provided it is well-controlled on stable medication
  • No current or recent (within the past 6 months) unstable angina
• No recent (within the past 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, or clinically significant peripheral artery disease
• No evidence of bleeding diathesis or coagulopathy
• No significant traumatic injury within the past 28 days
• No serious nonhealing wound, ulcer, or currently healing fracture
• No AIDS
• No significant infection or other coexisting medical condition that would preclude study therapy
• No gastrointestinal fistula or perforation within the past 10 years

PRIOR CONCURRENT THERAPY:

• More than 2 years since prior chemotherapy (other than for pancreaticobiliary cancer)
• More than 28 days since prior major surgical procedure or open biopsy
• No prior intraabdominal radiotherapy in the planned field of pancreatic margin-intensive radiotherapy
• No prior organ transplantation
• No concurrent major surgical procedure
• No other concurrent cytotoxic chemotherapy or anti-neoplastic biologic agents