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Testing the Use of the Usual Chemotherapy before and after Surgery for Removable Pancreatic Cancer

Trial Status: Active

This phase III trial compares perioperative chemotherapy (given around the time of 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 (perioperative) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvant).

Inclusion Criteria

  • PRE-REGISTRATION (STEP 0)
  • 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 degrees 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 * 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 (STEP 1)
  • 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

Alabama

Mobile
University of South Alabama Mitchell Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 251-445-9870

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-378-9373

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 818-847-4793
Burlingame
Mills-Peninsula Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Modesto
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Palo Alto
Palo Alto Medical Foundation Health Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Sutter Roseville Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Sacramento
Sutter Medical Center Sacramento
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
San Francisco
California Pacific Medical Center-Pacific Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Vallejo
Sutter Solano Medical Center / Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686

Connecticut

Danbury
Danbury Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-739-8074
Norwalk
Norwalk Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-852-2996

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 202-444-2223

Florida

Altamonte Springs
AdventHealth Altamonte
Status: ACTIVE
Contact: Site Public Contact
Phone: 407-303-2200
Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-674-2625
Miami Beach
Mount Sinai Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-674-2625
Orlando
AdventHealth Orlando
Status: ACTIVE
Contact: Site Public Contact
Phone: 407-303-2090

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Meridian
Idaho Urologic Institute-Meridian
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Meridian
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Nampa
Saint Alphonsus Medical Center-Nampa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Nampa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Post Falls
Kootenai Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Aurora
Rush - Copley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
University of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Carle Physician Group-Effingham
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-344-2831
Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360

Indiana

South Bend
Memorial Hospital of South Bend
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-284-7370

Iowa

Ames
Mary Greeley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Des Moines
Broadlawns Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-282-2921
West Des Moines
Methodist West Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-343-1000

Kentucky

Lexington
Baptist Health Lexington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-260-6425
Louisville
Baptist Health Louisville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 502-897-8592
Madisonville
Baptist Health Madisonville / Merle Mahr Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-733-2312

Michigan

Adrian
Hickman Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7058
Cape Girardeau
Saint Francis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-651-5550
Columbia
University of Missouri - Ellis Fischel
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-882-7440
Jefferson City
Capital Region Southwest Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-632-4814
Joplin
Mercy Hospital Joplin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Missouri Baptist Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Washington University School of Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Billings
Billings Clinic Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Omaha
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144

New York

East Syracuse
Hematology Oncology Associates of Central New York-East Syracuse
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 315-472-7504
Rochester
University of Rochester
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-862-2215

North Dakota

Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Chillicothe
Adena Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-779-7585
Columbus
Doctors Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433
Riverside Methodist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Dublin
Dublin Methodist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-752-9119
Grove City
Mount Carmel Grove City Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-779-7585
Mansfield
OhioHealth Mansfield Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-523-3977
Newark
Licking Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Toledo
Toledo Clinic Cancer Centers-Toledo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-3561
Westerville
Saint Ann's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433
Zanesville
Genesis Healthcare System Cancer Care Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-752-3402

Oregon

Bend
Saint Charles Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Providence Portland Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Pittsburgh
Allegheny General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-284-2000

South Carolina

Greenville
Prisma Health Cancer Institute - Eastside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Prisma Health Cancer Institute - Greer
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-788-8238
Centralia
Providence Regional Cancer System-Centralia
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Everett
Providence Regional Cancer Partnership
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-261-3529
Issaquah
Swedish Cancer Institute-Issaquah
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Lacey
Providence Regional Cancer System-Lacey
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-2016
Seattle
Swedish Medical Center-Ballard Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-788-8238
Vancouver
PeaceHealth Southwest Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-897-5993

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 715-623-9869
Medford
Aspirus Medford Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 715-847-2353
Wausau
Aspirus Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-405-6866
Wisconsin Rapids
Aspirus UW Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 715-422-7718

Wyoming

Sheridan
Welch Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVE:

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.

OTHER OBJECTIVE:

I. Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

EXPLORATORY OBJECTIVE:

I. Exploratory analyses will investigate the interaction of diet and molecular markers within tumors on the prognosis of patients with localized pancreatic cancer.

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, 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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Cristina R. Ferrone

  • Primary ID A021806
  • Secondary IDs NCI-2020-01560
  • Clinicaltrials.gov ID NCT04340141