This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support. 2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team) 1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD. 2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation.
1. Chemoradiation may be administered at selected approved CTN sites. 2. Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board. 1. Unresectable → Off study. Subsequent treatment per patient's primary MD. 2. Resectable → Continue to Registration #3 for Surgical Resection
1. Meets criteria for resectable\* →pancreaticoduodenectomy (POD) 2. At time of resection, snap frozen tumor specimen sent for correlative biomarker studies
Medical University of South Carolina
Charleston, South Carolina, United States
Estimate the R0/R1 Resection Rate
Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.
Time frame: at time of surgery
Radiographic Tumor Response
The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.
Time frame: From enrollment to Surgery
Histopathologic Tumor Response
Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.
Time frame: at the time of surgery
Time to Recurrence:
Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.
Time frame: 2 years
Overall Survival:
Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.