Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

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

   - Typically, tumors < 8.0 cm in greatest axial dimension but final determination of
   eligibility based upon radiation normal tissue constraints

   - Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2

   - Leukocytes (white blood cells, WBC) ≥ 3,000/mL

   - Absolute neutrophil count (ANC) ≥ 1,500/mL

   - Platelets ≥ 50,000/mL

   - Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)

   - Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 X
   institutional ULN

   - Creatinine within 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.

   - Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified
   FOLFIRINOX.

   - Age < 18 years

   - Uncontrolled intercurrent 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

      - 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 or lactating

   - 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) for
   duration of the study

   - Women who are not post-menopausal (as defined in Appendix III) and have a positive
   urine or serum pregnancy test or refuse to take a pregnancy test

   - Male subjects who are unwilling or unable to use effective contraception for duration
   of the study