Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Condition: Pancreas Neoplasm Malignant Resectable
MeSH terms: Pancreatic Neoplasms; Neoplasms
Intervention: Folfox6; Gemcitabine; Radiation Therapy; Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Pancreatic, cancer

Summary:

      To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy
      incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in
      combination with chemo-radiation with gemcitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma
             of the pancreatic head or body

          -  Patients must have radiographically-confirmed surgically resectable or borderline
             resectable disease at study entry staged at T1-3, NO-1 and MO

          -  Age >/= 18years

          -  Life expectancy of greater than 6 months in the opinion of the investigator, excluding
             theh pancreatic cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status </= 1

          -  Required laboratory data (see protocol)

          -  Disease assessment by CT scan within 4 weeks of study entry

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agent

          -  Patients with metastatic disease are excluded from this clinical trial

          -  History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and
             gemcitabine

          -  No prior chemotherapy or radiation therapy for pancreatic cancer (previous
             chemotherapy or radiation therapy for other malignancies is permitted)

          -  Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia,
             hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the
             institution, despite adequate electrolyte supplementation are excluded from this
             study.

          -  Uncontrolled serious intercurrent illness including, but not limited to, ongoing or
             serious active infection requiring IV antibiotics for over 30 days, symptomatic
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than
             chronic, stable atrial fibrillation, or psychiatric illness/social situations that
             would limit compliance with study requirements

          -  Pregnant or breastfeeding women are excluded from this study.

          -  Known HIV-positive patients are ineligible

          -  Patients with unresectable disease are excluded form the protocol (see Appendix B for
             National Comprehensive cancer Network [NCCN] criteria for determining resectability
             status). Surgical resectability must be confirmed by a surgeon experienced in
             pancreatic surgery.

          -  Patients with pancreatic tail lesions will be excluded