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

Inclusion Criteria

• •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