A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: FOLFIRINOX; Intensity-modulated radiotherapy (IMRT); Surgical Exploration
Intervention description: Starting dose levels as following:
Oxaliplatin 85mg/m2 intravenously over 120 minutes on day 1. Irinotecan 180mg/m2 intravenously over 90 minutes on day 1. NOTE: patients homozygous for the UGT1A1 (TA)7 promoter allele will be treated at an initial lower dose 140mg/m2 (please see Section 6.3.a) Leucovorin 400mg/m2 intravenously over 90 minutes on day 1. 5FU 400mg/m2 as bolus intravenous injection following leucovorin on day 1. 5FU 2,400mg/m2 infused intravenously as a continuous infusion over 46 hours following the bolus 5FU, beginning on day 1.; 50.0Gy in 2.0Gy per fraction; Patients without metastatic disease will be offered surgical exploration.
Intervention MeSH terms: Folfirinox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoadjuvant FOLFIRINOX; FDR-Gemcitabine; Concurrent; IMRT; Borderline Resectable Pancreatic Cancer

Summary:

      The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination
      of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic
      disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to
      address local disease, will achieve a significant improvement R0 resection (Radiation
      oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and
      enhance disease free and overall survival in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have cytologic or histologic confirmation of carcinoma arising in the
             pancreas.

          -  Patients must be deemed to have borderline resectable disease with no radiologic
             evidence of distant metastatic disease prior to registration.

          -  Specifically, patients must have at least one designation of borderline resectable and
             no designation of unresectable disease.

          -  Patients must have a life expectancy of at least 12 weeks, a Zubrod performance status
             of < 1 and be willing and medically able to undergo surgical resection.

          -  Patients must have adequate organ function defined as follows: absolute neutrophil
             count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin <
             2.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary
             stent).

          -  Patients must be free of other active systemic malignancy, ongoing infection, or any
             other serious uncontrolled, concomitant systemic disorders or psychiatric condition
             that would interfere with the safe delivery of protocol therapy.

          -  Patients of reproductive potential must agree to use an effective contraceptive method
             during participation in this trial due to the unacceptable teratogenic toxicity of
             abdominal radiation and cytotoxic chemotherapy.

          -  Patients must be aware of the investigational nature of the therapy and provide
             written informed consent.

        Exclusion Criteria:

          -  Patients with neuroendocrine tumors are excluded.

          -  Active systemic malignancy, ongoing infection, or any other serious uncontrolled,
             concomitant systemic disorders or psychiatric condition that would interfere with the
             safe delivery of protocol therapy.

          -  Patients with preexisting peripheral neuropathy > grade 2 are ineligible

          -  Pregnant or nursing women are ineligible.

          -  Patients must have no history of previous chemotherapy for pancreatic cancer or any
             abdominal radiation therapy.

          -  Patients may not have used any investigational agent within 4 weeks prior to
             enrollment into the study.