Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Pancreatic Cancer, Pancreatic Adenocarcinoma
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Folfirinox, Cancer, Radiation Therapy, neoadjuvent chemotherapy, Stereotactic Body Radiation Therapy (SBRT)
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Pathologic confirmation of pancreatic ductal adenocarcinoma
- Resectable disease (determined by treating surgeon)
- Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment
- No evidence of distant organ metastatic disease
- Eastern Cooperative Oncology Group Performance status 0-1
- Ability to understand and the willingness to sign informed consent document
Adequate organ function, defined by the following laboratory values, at the time of study entry:
- Hemoglobin ≥ 10 g/dL (transfusions acceptable)
- Absolute Neutrophil Count ≥ 0.5 x 109/L
- Platelets ≥ 100 x 109/L
- Creatinine ≤ 1.5x institutional upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min
- Total bilirubin ≤ 2x institutional ULN
- Aspartate aminotransferase test (AST)/ Alanine Aminotransferase Test (ALT) ≤ 3x institutional ULD
Exclusion Criteria:
- Severe/uncontrolled intercurrent illness that, in the opinion of the patient's treating physicians, would prevent the patient from receiving either multi agent chemotherapy, high-dose radiation, or undergoing resection of the pancreatic tumor
- Prior therapy for PDAC
- Prior radiation to the upper abdomen (RT to other sites acceptable)
- Inability to undergo port or PICC line placement
- Active gastric or duodenal ulcer
- Tumor invasion of the intestinal or gastric lumen
- Active hepatitis B or other active serious infections
- Pregnant and breastfeeding women are excluded. Women of child-bearing potential must have a negative urine or serum pregnancy test and be willing to use acceptable methods of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study treatment
- Life expectancy of < 3 months
- Patients with contraindications to either PET scan or MRI (e.g., pacemaker/ICD) will NOT be excluded from study participation. Such patients will be treated per protocol but will not be required to undergo PET-MRI.
Sites / Locations
- Indiana University Melvin & Bren Simon Cancer Center
Arms of the Study
Arm 1
Experimental
Preoperative Chemotherapy + SBRT
Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines. After 6 cycles of neoadjuvant therapy are completed, patients will undergo imaging with pancreatic protocol CT and PET-MRI to assess disease status . Patients without evidence of disease progression at the end of 6 cycles of neoadjuvant treatment will proceed to SBRT followed by surgical resection. Following surgery, patients will receive an additional 6 cycles of FOLFIRINOX chemotherapy.