64
Participants
Start Date
August 1, 2023
Primary Completion Date
July 31, 2028
Study Completion Date
July 31, 2029
Nab paclitaxel
"The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month.~The patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician."
Gemcitabine
"The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month.~The patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician."
Radiological Assessments
CT imaging of chest abdomen and pelvis will be performed every 8 weeks. MRI may be used.
mFOLFIRINOX
"The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month.~The patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician."
RECRUITING
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER