Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma
Condition: Adenocarcinoma of Head of Pancreas
MeSH terms: Adenocarcinoma
Intervention: Neo-adjuvant Chemotherapy; Chemoradiation; Surgical Resection
Intervention description: Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support.
Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team)
Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD.
Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation.; Chemoradiation may be administered at selected approved CTN sites.
Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board.
Unresectable → Off study. Subsequent treatment per patient's primary MD.
Resectable → Continue to Registration #3 for Surgical Resection; Meets criteria for resectable* →pancreaticoduodenectomy (POD)
At time of resection, snap frozen tumor specimen sent for correlative biomarker studies
Intervention MeSH terms: Folfirinox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: NEOADJUVANT FOLFIRINOX CHEMOTHERAPY; LOCALIZED PANCREATIC HEAD ADENOCARCINOMA; RADIATION THERAPY

Summary:

      This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research
      study is to determine the safety and effectiveness of modified Folfirinox and radiation
      therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening
      tests will be done to determine if subjects are eligible for participation in this study. If
      subjects are eligible to participate and agree to participate they will begin chemotherapy.
      After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of
      completing radiation therapy, subjects will have surgery. There will also be post-treatment
      and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after
      their initial registration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has histologically or cytologically confirmed borderline resectable
             adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine
             neoplasms are excluded.

          -  Borderline resectable disease as outlined in the protocol

          -  ≥ 18 years of age.

          -  Male or non-pregnant and non-lactating female. If a female patient is of childbearing
             potential, she must have a negative serum pregnancy test (β hCG) documented within 72
             hours of the first administration of study drug.

          -  If sexually active, the patient must agree to use contraception considered adequate
             and appropriate by the Investigator.

          -  Patient must not have received prior chemotherapy or radiation for pancreatic cancer
             and no exposure to systemic chemotherapy.

          -  Patient have acceptable blood counts, chemistries & coagulation at baseline as
             outlined in the protocol

          -  Patient has an ECOG performance status PS 0-1.

          -  Patient has been informed about the nature of the study and has agreed to participate
             in the study and signed the Informed Consent Form prior to participation in any
             study-related activities.

          -  Endoscopic ultrasound (EUS) with FNA for cytology.

          -  Patients should not have any evidence of active or uncontrolled infection requiring
             treatment with antibiotics.

        Exclusion Criteria:

          -  Patient has localized resectable, locally advanced unresectable or advanced metastatic
             disease. Patients with adenocarcinoma of the pancreatic body or tail are ineligible.

          -  Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
             systemic therapy.

          -  Patient has known infection with HIV.

          -  Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done
             to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to
             Day 1 of treatment in this study.

          -  Prior chemotherapy, immunotherapy or radiation for pancreatic cancer.

          -  Patient has a history of allergy or hypersensitivity to the study drugs.

          -  Patient has serious medical risk factors involving any of the major organ systems such
             that the Investigator considers it unsafe for the patient to receive chemotherapy
             and/or radiation therapy.

          -  Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate,
             cyclosporine).

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             Stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for five years.

          -  Patients must not have clinically significant cardiovascular disease (including
             myocardial infarction, unstable angina, symptomatic congestive heart failure, serious
             uncontrolled cardiac arrhythmia) < 1 year before randomization.

          -  Patients must not have a history of any medical or psychiatric condition or laboratory
             abnormality that in the opinion of the investigator may increase the risks associated
             with the study participation or investigational product(s) administration or may
             interfere with the interpretation of the results.

          -  Patient is unwilling or unable to comply with study procedures.

          -  Patient is enrolled in any other therapeutic clinical protocol or investigational
             trial.

          -  Patients aged > 70