The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery.
Primary Objective: To evaluate the percentage of pancreatic cancer patients able to complete the full 4 months of preoperative chemotherapy and undergo a resection. Secondary Objectives * To assess the percentage of patients able to complete all therapy, including preoperative chemotherapy, surgery, and postoperative therapy. * To assess treatment-related toxicity during preoperative therapy * To assess intra-operative and post-operative complications * To assess the histopathologic (R0/R1) resection rate after preoperative therapy * To determine disease free survival (DFS) for patients who undergo resection. * To determine progression free survival (PFS) for all patients * To determine overall survival (OS) from the date of first treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
FOLFIRINOX administered preoperatively and postoperatively
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection
Measured by percentage of successes/failures
Time frame: 4 months
The extent of preoperative chemotherapy, surgery, and adjuvant chemotherapy.
Reported as a yes/no for each element of therapy.
Time frame: 6 months
Presence of adverse events
Presence of grade 3 and 4 toxicities measured according to NCI CTCAE version 4.0.
Time frame: 6 months
Intraoperative and post-op complications
Any unexpected events as determined by surgical oncologist
Time frame: Within 6 weeks post surgery
R0/R1 resection rates
Measured as proportion of patients with microscopic negative and microscopic residual tumor margin
Time frame: 6 months
Disease free survival
Defined by date from surgical resection to radiographic recurrence or death
Time frame: Up to 5 years
Progression free survival
Defined by radiographic progression by RECIST criteria or death
Time frame: Up to 5 years
Overall survival
Defined by date from Cycle 1 Day 1 of preoperative chemotherapy to death from any cause.
Time frame: Up to 5 years
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