Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

Official Title

A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer

Summary:

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 Radiation Therapy (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.

Trial Description

Primary Outcome:

  • difference in progression-free survival between mFOLFIRINOX alone vs. mFOLFIRINOX and SBRT
A Pancreatic Cancer Radiation Therapy Study Group (PanCRS) Trial

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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society