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Lead
Yale University
Given the superior outcomes with FOLFIRINOX and the potential for improved local response with SBRT, the investigators propose to evaluate the efficacy of pre-operative modified FOLFIRINOX followed by SBRT in patients with borderline resectable pancreatic adenocarcinoma. The investigators hypothesize that pre-operative modified FOLFIRINOX followed by SBRT will improve the rate of R0 resections compared to historical controls treated with standard gemcitabine-based chemotherapy and fractionated radiation prior to surgery.
Borderline resectable pancreatic adenocarcinoma, determined centrally by review of a diagnostic CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist, or as determined by EUS, and defined according to the NCCN consensus guidelines
ECOG Performance Status of 0-1
Age \> 18
Laboratory parameters as follows:
* Absolute neutrophil count \>=1,500/uL
* Platelet count \>=100,000/uL
* Hemoglobin \>=9 g/dL
* Creatinine \<1.5 X ULN or estimated GFR \>30 ml/min
* Bilirubin =\<1.5 X ULN
* AST and ALT =\<3 X ULN
* Negative pregnancy test in women of childbearing potential
Able to have fiducials placed in the pancreas
Patients who received chemotherapy \>5 years ago for malignancies other than pancreatic cancer are eligible
You may not be if
Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI, or PET scan), or laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or distant metastases
Evidence of invasion into the duodenum or stomach, as determined by EGD/EUS
Prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer
Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabine
Major surgery within 4 weeks of study entry
Other concurrent anticancer therapies
Other malignancy within the past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer)
Evidence of second malignancy at the time of study entry
Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
Grade 2 or greater sensory peripheral neuropathy
Uncontrolled seizure disorder, active neurological disease, or known CNS disease
Significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
Pregnant or nursing
Other medical condition or reason that, in the opinion of the investigator, would preclude study participation
Clareo Health | Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
