Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Oxaliplatin; Irinotecan; Leucovorin; 5FU; Stereotactic Body Radiotherapy (SBRT)
Intervention description: Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.; Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.; Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.; 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.; Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Camptothecin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to determine the safety and efficacy of a chemotherapy regimen
      known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body
      Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the
      disease and improve survival for patients with locally advanced pancreatic cancer.
    

Eligibility criteria:

        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