Borderline Pancreas Study: FOLFIRINOX +SBRT (GCC 1324)

This is an interventional treatment trial for Resectable Pancreatic Cancer focused on measuring pancreatic cancer Read More

Inclusion Criteria:

• ≥ 18 years at diagnosis.
• Biopsy proven pancreatic adenocarcinoma.
• Borderline resectable per NCCN criteria (No distant metastases, venous involvement of the portal vein/SMV, demonstrating tumor abutment and narrowing of the lumen, encasement of the portal vein/SMV without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal or distal to this area of vessel involvement, allowing for safe resection and reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; tumor abutment of the SMA not to exceed 180 degrees of the circumference of the vessel wall.).
• Radiologically measurable or clinically evaluable disease.
• Pancreas protocol CT and/or MRI if required for further clarification of disease tissue planes within 4 weeks of registration.
• ECOG PS of 0-2.
• Able to get a Whipple resection per surgeon assessment performed within 4 weeks of registration.
• The following laboratory values obtained ≤ 28 days prior to registration:
• Absolute neutrophil count (ANC) ≥ 1,500/mm3.
• Platelet count ≥ 100,000/mm3.
• Hemoglobin > 8.0 g/dL.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
• SGOT (AST) ≤ 2 x ULN.
• SGPT (ALT) ≤ 2 x ULN.
• Creatinine ≤ 1.5 x ULN.
• CA 19-9 level (to establish baseline).
• A negative pregnancy test within 7 days prior to registration for women of childbearing potential. In addition, male and female participants must commit to adequate contraception while on study.
• Able to provide written informed consent.
• Willing to return for all required study assessments.
• Neurological assessment for pre-existing peripheral neuropathy.
• Documentation of pre-existing hearing deficits.

Exclusion Criteria:

• Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease.
• Prior history of abdominal radiation therapy.
• History of autoimmune disease such as scleroderma, lupus, and inflammatory bowel disease.
• Patients with tumor-caused symptomatic bowel obstruction.
• Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.
• Other invasive malignancies within the past 5 years from date of registration.
• Pregnant or nursing women or women of childbearing age that are unwilling to employ adequate contraception.
• Other co-morbid conditions which, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.