Combination Chemotherapy with or without Stereotactic Body Radiation Therapy in Treating Patients with Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the pancreas
• Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board
• Stable or better disease on re-staging scans following induction mFOLFIRINOX
• Typically, pancreatic tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning but final determination of eligibility will be based upon satisfying the radiation normal tissue constraints
• No prior systemic therapy EXCEPT patients may be consented and enrolled if they have already started mFOLFIRINOX for up to four cycles
• Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
• Within 30 days of eligibility confirmation: Leukocytes (white blood cells [WBC]) >= 3,000/uL
• Within 30 days of eligibility confirmation: Absolute neutrophil count (ANC) >= 1,500 uL
• Within 30 days of eligibility confirmation: Platelets >= 50,000/uL
• Within 30 days of eligibility confirmation: Total bilirubin =< 1.5 X institutional upper limit of normal
• Within 30 days of eligibility confirmation: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
• Within 30 days of eligibility confirmation: Creatinine not above the upper limit of normal institutional limits
• Ability to understand and the willingness to sign an informed consent form
• Life expectancy > 6 months

Exclusion Criteria

• Metastatic disease
• Prior radiotherapy to the upper abdomen/liver
• Patients who have received chemotherapy for pancreatic cancer, other than up to 4 cycles of mFOLFIRINOX as noted above
• Uncontrolled illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial
• Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study; male subjects must also agree to use effective contraception for the same period as above; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test