Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

The Primary and Secondary are listed below.

Primary Objective:

• To evaluate progression free survival after modified FOLFIRINOX and SBRT in borderline resectable and locally advanced pancreatic cancer.

Secondary Objective:

• To evaluate the radiographic response to FOLFIRINOX and SBRT by comparing IV contrast CT scans before and after therapy.
• To determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival.
• To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

Inclusion criteria

• Histologically confirmed pancreatic adenocarcinoma
• Borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma
• No evidence of extrapancreatic disease on diagnostic imaging
• No evidence of invasion into the duodenum or stomach, as determined by EGD/EUS
• No prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer
• No prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine
• ECOG Performance Status of 0-1
• No other malignancy within past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer)
• No evidence of second malignancy at the time of study entry
• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• No > grade 2 sensory peripheral neuropathy
• No uncontrolled seizure disorder, active neurological disease, or known CNS disease
• No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
• Not pregnant and not nursing
• No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
• Laboratory parameters as follows:

• Absolute neutrophil count ≥1,500/uL,
• Platelet count ≥75,000/uL,
• Hemoglobin ≥9 g,/dL,
• Creatinine <1.5 X ULN or estimated GFR >30 ml/min,
• Bilirubin <1.5 X ULN,
• AST and ALT <3 X ULN,
• Negative pregnancy test in women of childbearing potential
• Able to be treated with SBRT only at the Smilow New Haven campus
• Able to have fiducials placed in the pancreas

Exclusion criteria

• Failing to meet any of the Inclusion Criteria