This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.
Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B * Treatment will be administered on an outpatient basis. * Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel). * After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine . * Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Massachusetts General Hospital
Boston, Massachusetts, United States
Survival Rate at 18 Month
Number of participants surviving after 18 months of study follow-up
Time frame: 18 Month
Pathologic Complete Response Rate (pCR).
Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.
Time frame: 18 Months
Overall Survival Rate
Overall survival rate at five years using Kaplan-Meier survival analysis
Time frame: Baseline, 5 Years
Number of Participants With Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days
Time frame: Baseline, 28 Days
Surgical Morbidity Rate
Number of patients experiencing a specific surgery related morbidity
Time frame: within 30 days of surgery
30-day Post-operative Mortality Rate
Number of patients who died following surgery.
Time frame: 30 Days
Correlation of Biomarkers With PFS
Analysis of the correlation between selected bio-markers and progression free survival.
Time frame: 2 Years
Rate of Pathologic Downstaging
The number of participants achieving a reduction in the pathological staging of the primary cancer.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 Years
Local Control Rate
The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.
Time frame: 2 Years