Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2029

Conditions
Pancreas AdenocarcinomaBorderline Resectable Pancreatic AdenocarcinomaLocally Advanced Pancreatic Adenocarcinoma
Interventions
DRUG

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."

DRUG

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."

OTHER

Radiological Assessments

CT imaging of chest abdomen and pelvis will be performed every 8 weeks. MRI may be used.

DRUG

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."

Trial Locations (1)

27157

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Wake Forest University Health Sciences

OTHER