Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT01926197|
Recruitment Status : Recruiting
First Posted : August 20, 2013
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Oxaliplatin Radiation: SBRT Drug: Irinotecan Drug: Leucovorin Drug: 5FU||Phase 3|
A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial
To determine progression free survival for mFFX +/- SBRT.
- 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 (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Active Comparator: mFFX
mFOLFIRINOX + SBRT
- difference in progression-free survival between mFOLFIRINOX alone vs. mFOLFIRINOX and SBRT [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926197
|Contact: Samantha Wongemail@example.com|
|United States, California|
|UCLA||Active, not recruiting|
|Los Angeles, California, United States, 60153|
|UCSF||Active, not recruiting|
|San Francisco, California, United States, 94143|
|Stanford University, School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Samantha Wong 650-498-8495 firstname.lastname@example.org|
|Principal Investigator: Daniel T Chang|
|United States, Illinois|
|Maywood, Illinois, United States, 60153|
|Contact: Beth Chiappetta, RN 708-216-2568 BCHIAPPETTA@lumc.edu|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: David Marshall, MD 843-792-3273 email@example.com|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jeffrey Meyer, MD,MS 214-645-7604 Jeffrey.Meyer@UTSouthwestern.edu|
|United States, Washington|
|Swedish Cancer Institute||Recruiting|
|Seattle, Washington, United States, 98107|
|Contact: Vivek Mehta Vivek.Mehta@swedish.org|
|Canada, British Columbia|
|BC Cancer Agency||Active, not recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Laura Dawson 416-946-2127 ext 4820 Laura.Dawson@rmp.uhn.on.ca|
|Principal Investigator:||Daniel T Chang||Stanford University|