Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer

February 9, 2026 updated by: Alliance for Clinical Trials in Oncology

A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma treated with perioperative fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

SECONDARY OBJECTIVES:

I. To evaluate and compare disease-free survival (DFS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

II. To evaluate and compare time to locoregional recurrence (TLR) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

III. To evaluate and compare time to distant metastases (TDM) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

IV. To evaluate and compare the R0 resection rate in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

V. To evaluate and compare rate of unresectability in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

VI. To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm.

VII. To evaluate and compare mFOLFIRINOX dose intensity delivered and number of cycles received in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

VIII. To evaluate and compare adverse event profile in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

IX. To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) between patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

X. To prospectively assess the influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the disease-free survival and overall survival among patients with localized pancreatic cancers.

XI. To assess the influence of diet, obesity, physical activity, and other lifestyle habits on the risk of toxicity associated with chemotherapy.

XII. To evaluate the ability of computed tomography (CT)-based radiomics in distinguishing post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor in patients randomized to the perioperative therapy arm.

XIII. To determine whether CT-based radiomics retrieved from baseline examination may act as non-invasive predictors of survival outcome in patients randomized to the adjuvant therapy arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 6 years.

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • BCCA-Vancouver Island Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre/Nova Scotia Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital and Cancer Center-General Campus
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • The Research Institute of the McGill University Health Centre (MUHC)
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
      • Fairhope, Alabama, United States, 36532
        • Thomas Hospital
      • Mobile, Alabama, United States, 36688
        • University of South Alabama Mitchell Cancer Institute
      • Mobile, Alabama, United States, 36607
        • Mobile Infirmary Medical Center
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Anaheim, California, United States, 92806
        • Kaiser Permanente-Anaheim
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Auburn, California, United States, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Bellflower, California, United States, 90706
        • Kaiser Permanente-Bellflower
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Burlingame, California, United States, 94010
        • Mills-Peninsula Medical Center
      • Cameron Park, California, United States, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Clovis, California, United States, 93611
        • Community Cancer Institute
      • Costa Mesa, California, United States, 92627
        • UC Irvine Health Cancer Center-Newport
      • Dublin, California, United States, 94568
        • Kaiser Permanente Dublin
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • Fresno, California, United States, 93720
        • Kaiser Permanente Fresno Orchard Plaza
      • Irvine, California, United States, 92618
        • Kaiser Permanente-Irvine
      • Irvine, California, United States, 92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90034
        • Kaiser Permanente West Los Angeles
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute Palo Alto
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Redwood City, California, United States, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Riverside, California, United States, 92505
        • Kaiser Permanente-Riverside
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Roseville, California, United States, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Roseville, California, United States, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • San Diego, California, United States, 92120
        • Kaiser Permanente-San Diego Zion
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center - Hillcrest
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Mateo, California, United States, 94401
        • Mills Health Center
      • San Rafael, California, United States, 94903
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center/Cancer Center
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
    • Colorado
      • Denver, Colorado, United States, 80210
        • AdventHealth Porter
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Derby, Connecticut, United States, 06418
        • Smilow Cancer Hospital-Derby Care Center
      • Fairfield, Connecticut, United States, 06824
        • Smilow Cancer Hospital Care Center-Fairfield
      • Glastonbury, Connecticut, United States, 06033
        • Smilow Cancer Hospital Care Center at Glastonbury
      • Greenwich, Connecticut, United States, 06830
        • Smilow Cancer Hospital Care Center at Greenwich
      • Guilford, Connecticut, United States, 06437
        • Smilow Cancer Hospital Care Center - Guilford
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Meriden, Connecticut, United States, 06451
        • Midstate Medical Center
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • North Haven, Connecticut, United States, 06473
        • Yale-New Haven Hospital North Haven Medical Center
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
      • Orange, Connecticut, United States, 06477
        • Smilow Cancer Hospital-Orange Care Center
      • Torrington, Connecticut, United States, 06790
        • Smilow Cancer Hospital-Torrington Care Center
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • Waterbury, Connecticut, United States, 06708
        • Smilow Cancer Hospital-Waterbury Care Center
      • Waterford, Connecticut, United States, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
      • Washington D.C., District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • AdventHealth Altamonte
      • Aventura, Florida, United States, 33180
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Bonita Springs, Florida, United States, 34135
        • Schulze Family Foundation Cancer Clinic - Bonita Health Center
      • Coral Gables, Florida, United States, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Deerfield Beach, Florida, United States, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Fort Myers, Florida, United States, 33905
        • Regional Cancer Center-Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • UF Health Cancer Institute - Gainesville
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Health Hollis Cancer Center
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, United States, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Plantation, Florida, United States, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Weston, Florida, United States, 33331
        • Cleveland Clinic-Weston
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Putney Memorial Hospital
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center-Gainesville
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, United States, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • DeKalb, Illinois, United States, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Mount Vernon, Illinois, United States, 62864
        • SSM Health Good Samaritan
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • Oak Brook, Illinois, United States, 60523
        • Northwestern Medicine Oak Brook
      • Orland Park, Illinois, United States, 60462
        • University of Chicago Medicine-Orland Park
      • Orland Park, Illinois, United States, 60462
        • Northwestern Medicine Orland Park
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Urbana, Illinois, United States, 61801
        • The Carle Foundation Hospital
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Ankeny, Iowa, United States, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • West Des Moines, Iowa, United States, 50266-7700
        • Methodist West Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
      • Madisonville, Kentucky, United States, 42431
        • Baptist Health Madisonville/Merle Mahr Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
        • LSU Health Baton Rouge-North Clinic
      • Baton Rouge, Louisiana, United States, 70809
        • Louisiana Hematology Oncology Associates LLC
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, United States, 70816
        • Medical Center of Baton Rouge
      • Baton Rouge, Louisiana, United States, 70836
        • Ochsner High Grove
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Physician Group
      • Covington, Louisiana, United States, 70433
        • Northshore Oncology Associates-Covington
      • Covington, Louisiana, United States, 70433
        • Ochsner Hematology Oncology North Shore - Covington (West Region)
      • Houma, Louisiana, United States, 70360
        • Terrebonne General Medical Center
      • Kenner, Louisiana, United States, 70065
        • Ochsner Medical Center Kenner
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Towson, Maryland, United States, 21204
        • UM Saint Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center
      • Peabody, Massachusetts, United States, 01960
        • Lahey Medical Center-Peabody
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, United States, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, United States, 48188
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, United States, 48118
        • Chelsea Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48236
        • Henry Ford Health Saint John Hospital
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Novi, Michigan, United States, 48374
        • Henry Ford Health Providence Novi Hospital
      • Royal Oak, Michigan, United States, 48073
        • Corewell Health William Beaumont University Hospital
      • Saginaw, Michigan, United States, 48601
        • MyMichigan Medical Center Saginaw
      • Southfield, Michigan, United States, 48075
        • Henry Ford Health Providence Southfield Hospital
      • Troy, Michigan, United States, 48085
        • Corewell Health Beaumont Troy Hospital
      • Warren, Michigan, United States, 48093
        • Henry Ford Health Warren Hospital
    • Mississippi
      • Grenada, Mississippi, United States, 38901
        • Baptist Cancer Center-Grenada
      • New Albany, Mississippi, United States, 38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, United States, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Columbia, Missouri, United States, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Jefferson City, Missouri, United States, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, United States, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • BJC Outpatient Center at Sunset Hills
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Charleston
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Jersey City, New Jersey, United States, 07302
        • Jersey City Medical Center
      • Lakewood, New Jersey, United States, 08701
        • Monmouth Medical Center Southern Campus
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital - Luckow Pavilion
      • Ridgewood, New Jersey, United States, 07450
        • Valley Health System Ridgewood Campus
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
    • New York
      • Bay Shore, New York, United States, 11706
        • South Shore University Hospital
      • Bay Shore, New York, United States, 11706
        • Northwell Health Imbert Cancer Center
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • East Hills, New York, United States, 11548
        • The Cancer Institute at Saint Francis Hospital
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • Greenlawn, New York, United States, 11740
        • Northwell Health Cancer Institute at Huntington
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Lake Success, New York, United States, 11042
        • Northwell Health/Center for Advanced Medicine
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10019
        • Mount Sinai West
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10065
        • Manhattan Eye Ear and Throat Hospital
      • Oswego, New York, United States, 13126
        • Upstate Cancer Center at Oswego
      • Rego Park, New York, United States, 11374
        • Queens Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, United States, 13215
        • SUNY Upstate Medical Center-Community Campus
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
      • Verona, New York, United States, 13478
        • Upstate Cancer Center at Verona
      • Webster, New York, United States, 14580
        • Wilmot Cancer Institute at Webster
      • White Plains, New York, United States, 10601
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
      • Kinston, North Carolina, United States, 28501
        • ECU Health Oncology Kinston
      • New Bern, North Carolina, United States, 28561
        • CarolinaEast Medical Center
      • Raleigh, North Carolina, United States, 27607
        • Duke Women's Cancer Care Raleigh
      • Raleigh, North Carolina, United States, 27609
        • Duke Cancer Center Raleigh
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital South
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dublin, Ohio, United States, 43016
        • Dublin Methodist Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Miami Valley Cancer Care and Infusion
      • Grove City, Ohio, United States, 43123
        • Mount Carmel Grove City Hospital
      • Mansfield, Ohio, United States, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Mansfield, Ohio, United States, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Newark Radiation Oncology
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Ephrata, Pennsylvania, United States, 17522
        • Ephrata Cancer Center
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Hospital
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Jefferson Hospital
      • Lebanon, Pennsylvania, United States, 17042
        • Sechler Family Cancer Center
      • Monroeville, Pennsylvania, United States, 15146
        • Forbes Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wexford, Pennsylvania, United States, 15090
        • Wexford Health and Wellness Pavilion
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavilion
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Cancer Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Westerly, Rhode Island, United States, 02891
        • Smilow Cancer Hospital Care Center - Westerly
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H Johnson VA Medical Center
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Avera Cancer Institute-Aberdeen
      • Mitchell, South Dakota, United States, 57301
        • Avera Cancer Institute - Mitchell
      • Pierre, South Dakota, United States, 57501
        • Avera Cancer Institute at Pierre
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
      • Yankton, South Dakota, United States, 57078
        • Avera Cancer Institute at Yankton
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee - Knoxville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
    • Texas
      • Amarillo, Texas, United States, 79106
        • The Don and Sybil Harrington Cancer Center
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, United States, 75237
        • UT Southwestern Simmons Cancer Center - RedBird
      • Fort Worth, Texas, United States, 76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson, Texas, United States, 75080
        • UT Southwestern Clinical Center at Richardson/Plano
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Fairfax, Virginia, United States, 22033
        • Inova Fair Oaks Hospital
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Leesburg, Virginia, United States, 20176
        • Inova Loudoun Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Norfolk, Virginia, United States, 23502
        • Sentara Leigh Hospital
      • Richmond, Virginia, United States, 23298
        • VCU Massey Comprehensive Cancer Center
      • Roanoke, Virginia, United States, 24033
        • Carilion Roanoke Memorial Hospital
      • South Hill, Virginia, United States, 23970
        • VCU Community Memorial Health Center
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, United States, 98004
        • Overlake Medical Center
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Lacey, Washington, United States, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, United States, 98632
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, United States, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center
      • Sedro-Woolley, Washington, United States, 98284
        • PeaceHealth United General Medical Center
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Charleston Division
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Medford, Wisconsin, United States, 54451
        • Aspirus Medford Hospital
      • Mequon, Wisconsin, United States, 53097
        • Ascension Columbia Saint Mary's Hospital Ozaukee
      • Milwaukee, Wisconsin, United States, 53211
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus Cancer Care - Wisconsin Rapids
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

PRE-REGISTRATION:

  • Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma
  • TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs)
  • Resectable Primary Tumor: Local radiographic reading must be consistent with resectable disease defined as the following on 1) arterial and venous phase contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic magnetic resonance imaging (MRI) scan and 2) chest CT:

    • No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
    • Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
    • No evidence of metastatic disease
  • Measurable disease or non-measurable disease o Non-measurable disease is defined as cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by fine needle aspiration or core-biopsy of the pancreas without measurable disease by radiographic imaging

REGISTRATION:

  • Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio
  • Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection
  • No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
  • Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Total Neuropathy Score < 2
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • Platelet count >= 100,000/uL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin =< 3.0)
  • Creatinine =< 1.5 x ULN OR calculated (Calc.) creatinine clearance >= 30 mL/min (Calculated using the Cockcroft-Gault equation)
  • No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
  • No comorbid conditions that would prohibit curative-intent pancreatectomy
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration
  • Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inducers must discontinue the drug prior to registration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (perioperative chemotherapy, surgery)
Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
Ancillary studies
Given IV
Given IV
Given IV
Given IV
Undergo surgical resection
Active Comparator: Arm II (surgery, adjuvant chemotherapy)
Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Ancillary studies
Given IV
Given IV
Given IV
Given IV
Undergo surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Time between randomization and death from any cause, assessed up to 6 years.
Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Time between randomization and death from any cause, assessed up to 6 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years.
Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years.
Time to locoregional recurrence (TLR)
Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years.
Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time between randomization and locoregional recurrence after resection, assessed up to 6 years.
Time to distant metastases (TDM)
Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years.
Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years.
R0 resection rate
Time Frame: At time of surgery.
The rate (percentage) of patients with negative resection margins after undergoing surgery.
At time of surgery.
Rate of unresectability
Time Frame: At time of surgery or planned time of surgery.
The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
At time of surgery or planned time of surgery.
Pathologic complete response (pCR) rate
Time Frame: At time of surgery.
The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
At time of surgery.
Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0)
Time Frame: Up to 2 years.
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
Up to 2 years.
Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered
Time Frame: 8 months
Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
8 months
Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received
Time Frame: 8 months
The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
8 months
Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30)
Time Frame: 8 weeks
Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
8 weeks
Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival
Time Frame: Time between randomization and death from any cause, assessed up to 6 years.
Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
Time between randomization and death from any cause, assessed up to 6 years.
Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS)
Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years.
Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years.
Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy
Time Frame: Up to 2 years.
Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
Up to 2 years.
The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation
Time Frame: At time of surgery.
Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
At time of surgery.
Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival
Time Frame: Time between randomization and death from any cause, assessed up to 6 years.
Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
Time between randomization and death from any cause, assessed up to 6 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Chair: Cristina R. Ferrone, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • A021806
  • U10CA180821 (U.S. NIH Grant/Contract)
  • NCI-2020-01560 (Registry Identifier: NCI Clinical Trial Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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