Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer
Condition: Pancreatic Adenocarcinoma; Borderline Resectable Adenocarcinoma of the Head of the Pancrease
MeSH terms: Adenocarcinoma
Intervention: radiation therapy; surgery; mFOLFIRINOX; FOLFOX
Intervention description: oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV; oxaliplatin IV, leucovorin IV and 5-FU IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with
      or without hypofractionated radiation therapy before surgery works in patients with
      pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy,
      such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy
      delivers higher doses of radiation therapy over a shorter period of time and may kill more
      tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is
      more effective with or without hypofractionated radiation therapy before surgery in treating
      patients with pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmation of radiographic stage as borderline resectable disease by real-time
             Alliance central radiographic review

          -  No prior chemotherapy or radiation for pancreatic cancer

          -  No definitive resection of pancreatic cancer

          -  Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3,
             subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on
             strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration
             on the study

          -  Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients
             must discontinue the drug 14 days prior to the start of study treatment

          -  No grade >= 2 neuropathy

          -  No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism

          -  No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days
             of registration

          -  Not pregnant and not nursing; for women of childbearing potential only, a negative
             pregnancy test done =< 7 days prior to registration is required

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Absolute neutrophil count (ANC) >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Creatinine =< 1.5 x upper limit of normal (ULN) or

          -  Calculated (calc.) creatinine clearance > 45 mL/min

          -  Total bilirubin =< 2.0 mg/dL

          -  Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 X upper limit
             of normal (ULN)