Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer
Pancreatic Adenocarcinoma, Borderline Resectable Adenocarcinoma of the Head of the Pancrease

About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
- No prior chemotherapy or radiation for pancreatic cancer
- No definitive resection of pancreatic cancer
- Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
- Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
- No grade >= 2 neuropathy
- No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism
- No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registration
- Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine =< 1.5 x upper limit of normal (ULN) or
- Calculated (calc.) creatinine clearance > 45 mL/min
- Total bilirubin =< 2.0 mg/dL
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)
Sites / Locations
- Southern Cancer Center PC-Mobile
- Southern Cancer Center PC-Springhill
- University of South Alabama Mitchell Cancer Institute
- Kaiser Permanente-Deer Valley Medical Center
- Alta Bates Summit Medical Center-Herrick Campus
- University Oncology Associates
- Kaiser Permanente-Fremont
- Kaiser Permanente-Fresno
- UC San Diego Moores Cancer Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente-Modesto
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Christiana Care Health System-Christiana Hospital
- MedStar Georgetown University Hospital
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Florida Hospital Orlando
- Memorial Hospital West
- Moffitt Cancer Center
- Northwest Community Hospital
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- NorthShore University HealthSystem-Evanston Hospital
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Loyola University Medical Center
- Edward Hospital/Cancer Center
- Edward Hospital/Cancer Center?Plainfield
- Northwestern Medicine Cancer Center Warrenville
- Goshen Center for Cancer Care
- Indiana University/Melvin and Bren Simon Cancer Center
- Iowa Methodist Medical Center
- University of Kansas Cancer Center
- University of Kansas Hospital-Westwood Cancer Center
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- Ochsner Medical Center Jefferson
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maine Medical Center- Scarborough Campus
- Saint Agnes Hospital
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Boston Medical Center
- Dana-Farber Cancer Institute
- University of Massachusetts Medical School
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Weisberg Cancer Treatment Center
- West Michigan Cancer Center
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Northern Michigan
- Ascension Saint Mary's Hospital
- Coborn Cancer Center at Saint Cloud Hospital
- Southeast Cancer Center
- University of Missouri - Ellis Fischel
- Missouri Baptist Medical Center
- CHI Health Good Samaritan
- Renown Regional Medical Center
- Dartmouth Hitchcock Medical Center
- Memorial Sloan Kettering Basking Ridge
- Memorial Sloan Kettering Monmouth
- Memorial Sloan Kettering Bergen
- Morristown Medical Center
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers Cancer Institute of New Jersey
- University of New Mexico Cancer Center
- Memorial Sloan Kettering Commack
- Memorial Sloan Kettering Westchester
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- NYP/Weill Cornell Medical Center
- University of Rochester
- State University of New York Upstate Medical University
- Memorial Sloan Kettering Nassau
- Atrium Health Stanly/LCI-Albemarle
- Mission Hospital Inc-Memorial Campus
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Atrium Health Lincoln/LCI-Lincoln
- Levine Cancer Institute-SouthPark
- Atrium Health University City/LCI-University
- Levine Cancer Institute-Mallard Creek
- Levine Cancer Institute-Ballantyne
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Atrium Health Union/LCI-Union
- Atrium Health Cleveland/LCI-Cleveland
- NHRMC Radiation Oncology - Supply
- New Hanover Regional Medical Center/Zimmer Cancer Center
- NHRMC Radiation Oncology - 16th Street
- Wake Forest University Health Sciences
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- University of Cincinnati/Barrett Cancer Center
- Ohio State University Comprehensive Cancer Center
- University of Oklahoma Health Sciences Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Penn State Milton S Hershey Medical Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Pottstown Hospital
- Reading Hospital
- Medical University of South Carolina
- Greenville Health System Cancer Institute-Faris
- Greenville Health System Cancer Institute-Eastside
- Levine Cancer Institute-Rock Hill
- Greenville Health System Cancer Institute-Seneca
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Vanderbilt University/Ingram Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- M D Anderson Cancer Center
- Huntsman Cancer Institute/University of Utah
- University of Virginia Cancer Center
- IMG Hematology Oncology 8501
- IMG Hematology Oncology 8505
- Inova Fairfax Hospital
- Seattle Cancer Care Alliance
- University of Washington Medical Center
- Edwards Comprehensive Cancer Center
- West Virginia University Healthcare
- University of Wisconsin Hospital and Clinics
- UW Cancer Center at ProHealth Care
- University Health Network-Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
mFOLFIRINOX + surgery + FOLFOX
mFOLFIRINOX + radiation + surgery + FOLFOX
Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.