Spots Global Cancer Trial Database for Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
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Trial Identification
Brief Title: Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
Official Title: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer: A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial
Study ID: NCT01926197
Conditions
Study Description
Brief 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 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Contact Details
Name: Daniel T Chang
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR
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