FOLFIRINOX + RT for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: FOLFIRINOX; Capecitabine; Short Course Radiation; Surgery
Intervention description: Up to Eight-14 day cycles; Orally, for 10 days; Five or ten days; 1-4 weeks after completion of capecitabine therapy
Intervention MeSH terms: Capecitabine; Oxaliplatin; Irinotecan; Folfirinox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Borderline resectable

Summary:

      This research study is a Phase II clinical trial. Phase II clinical trials test the
      effectiveness of a therapy to learn whether the therapy works in treating a specific cancer.
      "Investigational" means that the therapy is still being studied and that research doctors are
      trying to find out more about it-such as the safest dose to use, the side effects it may
      cause, and if therapy is effective for treating different types of cancer. Proton beam
      radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery
      system.

      Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as
      it delivers less radiation beyond the area of the target tissues. This may reduce side
      effects that patients would normally experience with standard (photon) radiation therapy,
      which tends to include more normal tissue along with tumor target tissue.

      Researchers in the laboratory have discovered that there are pathways inside the cells that
      can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and
      capecitabine are targeted towards blocking the pathways that allow cancer cells to divide,
      and may result in the tumor shrinking in size.

      In this research study, the investigators are looking to determine if proton beam radiation
      in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of
      your cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologic or histologic proof pancreatic ductal carcinoma

          -  Borderline resectable

          -  Life expectancy of at least 3 months

          -  ECOG Performance Status ≤ 1

          -  Adequate organ and bone marrow function

          -  No treatment of other invasive cancers within the last 5 years with greater than 5%
             risk of recurrence at the time of eligibility screening. Carcinoma in-situ and basal
             cell carcinoma/squamous cell carcinoma of the skin are allowed

          -  > 4 weeks since major surgery, excluding laparoscopy

        Exclusion Criteria:

          -  Evidence of metastatic disease

          -  Pregnant or breastfeeding

          -  Other serious uncontrolled medical conditions

          -  Prior chemotherapy, targeted/biologic therapy or radiation for treatment of the
             pancreatic tumor

          -  Prior systemic fluoropyrimidine therapy

          -  History of uncontrolled seizures, central nervous system disorders or psychiatric
             disability

          -  Individuals on cimetidine