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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04340141
Other study ID # A021806
Secondary ID NCI-2020-01560U1
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2020
Est. completion date November 2030

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact Cristina R. Ferrone, MD
Phone 617-643-6189
Email cferrone@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 352
Est. completion date November 2030
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxaliplatin
Given IV
Irinotecan Hydrochloride
Given IV
Leucovorin Calcium
Given IV
Fluorouracil
Given IV
Procedure:
Resection
Undergo surgical resection
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada QEII Health Sciences Centre/Nova Scotia Health Authority Halifax Nova Scotia
Canada Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario
Canada The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec
Canada Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario
Canada CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec City Quebec
Canada Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Quebec
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Canada BCCA-Vancouver Cancer Centre Vancouver British Columbia
Canada BCCA-Vancouver Island Cancer Centre Victoria British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Jefferson Abington Hospital Abington Pennsylvania
United States Hickman Cancer Center Adrian Michigan
United States Cleveland Clinic Akron General Akron Ohio
United States Phoebe Putney Memorial Hospital Albany Georgia
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States AdventHealth Altamonte Altamonte Springs Florida
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Augusta University Medical Center Augusta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Greater Baltimore Medical Center Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Medical Center of Baton Rouge Baton Rouge Louisiana
United States Ochsner High Grove Baton Rouge Louisiana
United States Our Lady of the Lake Physician Group Baton Rouge Louisiana
United States Northwell Health Imbert Cancer Center Bay Shore New York
United States South Shore University Hospital Bay Shore New York
United States Overlake Medical Center Bellevue Washington
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Billings Clinic Cancer Center Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Mills-Peninsula Medical Center Burlingame California
United States University of Vermont Medical Center Burlington Vermont
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Illinois CancerCare-Canton Canton Illinois
United States Trinity Health Medical Center - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Medical University of South Carolina Charleston South Carolina
United States Ralph H Johnson VA Medical Center Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Community Cancer Institute Clovis California
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Bay Area Hospital Coos Bay Oregon
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Ochsner Hematology Oncology North Shore - Covington (West Region) Covington Louisiana
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Danbury Hospital Danbury Connecticut
United States Carle at The Riverfront Danville Illinois
United States Miami Valley Hospital Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Porter Adventist Hospital Denver Colorado
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Dublin Methodist Hospital Dublin Ohio
United States Kaiser Permanente Dublin Dublin California
United States Duke University Medical Center Durham North Carolina
United States Cancer Institute at Saint Francis Hospital East Hills New York
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Englewood Hospital and Medical Center Englewood New Jersey
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Saint Vincent Hospital Erie Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Inova Fair Oaks Hospital Fairfax Virginia
United States Inova Schar Cancer Institute Fairfax Virginia
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Thomas Hospital Fairhope Alabama
United States Inova Fairfax Hospital Falls Church Virginia
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Regional Cancer Center-Lee Memorial Health System Fort Myers Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Kaiser Permanente-Fremont Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Adams Cancer Center Gettysburg Pennsylvania
United States Smilow Cancer Hospital Care Center at Glastonbury Glastonbury Connecticut
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Northwell Health Cancer Institute at Huntington Greenlawn New York
United States East Carolina University Greenville North Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Terrebonne General Medical Center Houma Louisiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Jefferson Hospital Jefferson Hills Pennsylvania
United States Jersey City Medical Center Jersey City New Jersey
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Mercy Hospital Joplin Joplin Missouri
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Ochsner Medical Center Kenner Kenner Louisiana
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States ECU Health Oncology Kinston Kinston North Carolina
United States University of Tennessee - Knoxville Knoxville Tennessee
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States Monmouth Medical Center Southern Campus Lakewood New Jersey
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Sechler Family Cancer Center Lebanon Pennsylvania
United States Inova Loudoun Hospital Leesburg Virginia
United States Baptist Health Lexington Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Barnabas Medical Center Livingston New Jersey
United States Monmouth Medical Center Long Branch New Jersey
United States PeaceHealth Saint John Medical Center Longview Washington
United States Cedars Sinai Medical Center Los Angeles California
United States Los Angeles General Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Baptist Health Louisville Louisville Kentucky
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States Illinois CancerCare-Macomb Macomb Illinois
United States Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville Kentucky
United States North Shore University Hospital Manhasset New York
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Marietta Memorial Hospital Marietta Ohio
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States Aspirus Medford Hospital Medford Wisconsin
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin
United States Midstate Medical Center Meriden Connecticut
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Mobile Infirmary Medical Center Mobile Alabama
United States University of South Alabama Mitchell Cancer Institute Mobile Alabama
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
United States Forbes Hospital Monroeville Pennsylvania
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Jersey Shore Medical Center Neptune New Jersey
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States CarolinaEast Medical Center New Bern North Carolina
United States The Hospital of Central Connecticut New Britain Connecticut
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Lenox Hill Hospital New York New York
United States Manhattan Eye Ear and Throat Hospital New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Hospital New York New York
United States Mount Sinai West New York New York
United States Licking Memorial Hospital Newark Ohio
United States Newark Radiation Oncology Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States Sentara Leigh Hospital Norfolk Virginia
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Norwalk Hospital Norwalk Connecticut
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Kaiser Permanente-Oakland Oakland California
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Northwestern Medicine Orland Park Orland Park Illinois
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States AdventHealth Orlando Orlando Florida
United States Upstate Cancer Center at Oswego Oswego New York
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States The Valley Hospital - Luckow Pavilion Paramus New Jersey
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States Kaiser Permanente Northwest Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Illinois CancerCare-Princeton Princeton Illinois
United States Duke Raleigh Hospital Raleigh North Carolina
United States Duke Women's Cancer Care Raleigh Raleigh North Carolina
United States Kaiser Permanente-Redwood City Redwood City California
United States Queens Cancer Center Rego Park New York
United States Renown Regional Medical Center Reno Nevada
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Kaiser Permanente-Richmond Richmond California
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Valley Health System Ridgewood Campus Ridgewood New Jersey
United States University of Rochester Rochester New York
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States UC San Diego Medical Center - Hillcrest San Diego California
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States UCSF Medical Center-Mission Bay San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Mills Health Center San Mateo California
United States Kaiser San Rafael-Gallinas San Rafael California
United States North Coast Cancer Care Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States FHCC South Lake Union Seattle Washington
United States Fred Hutchinson Cancer Center Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Welch Cancer Center Sheridan Wyoming
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States VCU Community Memorial Health Center South Hill Virginia
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Staten Island University Hospital Staten Island New York
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States State University of New York Upstate Medical University Syracuse New York
United States SUNY Upstate Medical Center-Community Campus Syracuse New York
United States Holy Name Hospital Teaneck New Jersey
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States University of Toledo Toledo Ohio
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States UM Saint Joseph Medical Center Towson Maryland
United States William Beaumont Hospital - Troy Troy Michigan
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Upstate Cancer Center at Verona Verona New York
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Wilmot Cancer Institute at Webster Webster New York
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Smilow Cancer Hospital Care Center - Westerly Westerly Rhode Island
United States Saint Ann's Hospital Westerville Ohio
United States Cleveland Clinic-Weston Weston Florida
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Wexford Health and Wellness Pavilion Wexford Pennsylvania
United States Dickstein Cancer Treatment Center White Plains New York
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States WellSpan Health-York Cancer Center York Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) 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 Disease-free survival (DFS) 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.
Secondary Time to locoregional recurrence (TLR) 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.
Secondary Time to distant metastases (TDM) 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.
Secondary R0 resection rate The rate (percentage) of patients with negative resection margins after undergoing surgery. At time of surgery.
Secondary Rate of unresectability 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.
Secondary Pathologic complete response (pCR) rate The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen. At time of surgery.
Secondary Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) 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.
Secondary Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered 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
Secondary Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received 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
Secondary Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) 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
Secondary Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival 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.
Secondary Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) 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.
Secondary 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 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.
Secondary 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 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.
Secondary Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival 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.
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