The purpose of this study is to evaluate the efficacy of modified FOLFIRINOX followed by stereotactic body radiotherapy (SBRT) in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). The primary hypothesis will be to determine if modified FOLFIRINOX followed by SBRT improves progression free survival (PFS) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.
The Primary and Secondary are listed below. Primary Objective: \- To evaluate progression free survival after modified FOLFIRINOX and SBRT in borderline resectable and locally advanced pancreatic cancer. Secondary Objective: * To evaluate the radiographic response to FOLFIRINOX and SBRT by comparing IV contrast CT scans before and after therapy. * To determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival. * To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks
Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved lymph nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
Yale University School of Medicine
New Haven, Connecticut, United States
Progression Free Survival
Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).
Time frame: 9 months
Radiographic Response
Radiographic response to FOLFIRINOX and SBRT will be done by comparing IV contrast CT scans before and after therapy.
Time frame: Within 21 days of starting study drug
Rates of Recurrence
Rates of recurrence (local only, systemic only, and both local and systemic) will be monitored for up to 3 years depending on time when the initiation of treatment begins.
Time frame: Up to 3 years
Rates of grade 3 or greater gastrointestinal toxicity
Grade 3 or greater gastrointestinal toxicities will be monitored including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.
Time frame: Up to 3 months post treatment
Overall Survival
Patients will be monitored for overall survival for up to 3 years depending on time when the initiation of treatment begins.
Time frame: Up to 3 years
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