The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.
Primary Objective: To determine progression free survival for mFFX +/- SBRT. Secondary Objectives: * To determine metastasis free survival following mFFX chemotherapy alone or with SBRT. * To determine the overall survival in pancreatic cancer patients treated with chemotherapy +/- SBRT. * To determine local progression-free survival in pancreatic cancer patients after chemotherapy +/- SBRT. * To evaluate acute (within 3 months of treatment) grade 2 or greater gastritis, fistula, enteritis, or ulcer and any other grade 3-4 gastrointestinal toxicity within 3 months of treatment. * To evaluate the utility of FDG-PET for treatment planning and estimation of progression free survival. * To identify new biomarkers in pancreatic cancer. * To evaluate the quality of life of patients before and after either chemotherapy or chemotherapy and SBRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
UCLA
Los Angeles, California, United States
UCSF
San Francisco, California, United States
Stanford University, School of Medicine
Stanford, California, United States
Loyola University
Maywood, Illinois, United States
Progression-free Survival (PFS)
Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Time frame: 38 months
Local Progression-free Survival (Local PFS)
Local progression-free survival (PFS) means the period of time that a participant remains alive without recurrence or advancement of the disease at the baseline sites of the tumor (local progression). The effect of the study treatments was assessed as the median local PFS of participants in the treatment groups. The outcome is reported as the median local PFS with standard deviation.
Time frame: 38 months
Progression-free Survival (PFS) at 1 Year
Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the number of participants in each treatment group that remained alive without tumor progression, at 1 year after treatment. The outcome is reported as a number without dispersion.
Time frame: 1 year
Metastasis-free Survival (MFS)
Metastasis-free survival (MFS) means the period of time that a participant remains alive without the appearance of new tumor lesions a distant site in the body (metastasis). The effect of the study treatments was assessed as the median MFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Time frame: 62 months
Overall Survival (OS)
The effect of the study treatments was assessed as the length of time participants in each treatment group that remained alive. The outcome is reported as the median OS with standard deviation.
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5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
BC Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Time frame: 62 months
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Toxicity means an adverse event related to the study treatment. Toxicity was assessed between treatment groups as the number of treatment-related , ≥ grade 2 events of gastritis, fistula, enteritis, or ulcer; plus any other Grade 3 to 5 gastrointestinal (GI) toxicity. The outcome is reported as the number of defined adverse events by preferred term for each treatment group, occurring within 3 months of the start of treatment. These adverse events by definition are all within the Common Terminology Criteria for Adverse Events (CTCAE) version 4.01 Gastrointestinal Body System. The outcome is reported as numbers without dispersion. All-cause Mortality mFFX 7 SBRT 8
Time frame: 3 months