Advanced Esophageal AdenocarcinomaPhase 3NCT05677490
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
A Phase 3 study testing Fluorouracil, Leucovorin Calcium and Oxaliplatin in people with Advanced Esophageal Adenocarcinoma and Advanced Gastric Adenocarcinoma, run by Alliance for Clinical Trials in Oncology at 798 sites in 2 countries.
Trial summary
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Fluorouracil, Leucovorin Calcium and Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 798 sitesin 2 countries
- Study dates
- 31 Jan 2023to 8 Nov 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology [JCO] 2017) with known PD-L1 combined positive score (CPS) (any CPS is allowed, but should be known prior to registration)
- Stage: unresectable or metastatic
- Tumor site: esophagus, gastroesophageal junction, or stomach
- Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- No prior systemic treatment for unresectable or metastatic disease
- Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration
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- 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 serum or urine pregnancy test done =< 7 days prior to registration is required
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min
- Total bilirubin =< 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (in patients with liver metastasis: =< 5 x ULN if clearly attributable to liver metastases)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
- On effective anti-retroviral therapy
- Undetectable HIV viral load by standard clinical assay =< 6 months of registration
- No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism
- No baseline grade >= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality
- No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose for more than four weeks
- No allogeneic tissue/organ transplant
- Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors
- Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
- Patients must not have a condition requiring systemic treatment with either corticosteroids (>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses (=< 10mg/day prednisone equivalent) are permitted
- Patients must not have a history of noninfectious pneumonitis requiring steroids
- Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible
Who cannot join
None listed.
Trial locations and contacts
798 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
307 sites in 2 countries
United States300 sites, 210 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Jared D. Acoba
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Jared D. Acoba
- Recruiting
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-487-7447
Jared D. Acoba
- Suspended
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Site Public Contact, rohta@queens.org
Jared D. Acoba
- Recruiting
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, 57401
Site Public Contact, 605-622-8700, oncregulatory@avera.org
Heidi A. McKean
- Suspended
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
- Suspended
Hickman Cancer Center
Adrian, Michigan, 49221
- Recruiting
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Christopher M. Reynolds
- Recruiting
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Christopher M. Reynolds
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Suspended
Katmai Oncology Group
Anchorage, Alaska, 99508
- Suspended
Providence Alaska Medical Center
Anchorage, Alaska, 99508
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Tatjana Kolevska
- Active, not recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Sutter Auburn Faith Hospital
Auburn, California, 95602
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Active, not recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Tanmay Sahai
- Recruiting
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Site Public Contact, ncorp@aah.org
Edward S. James
- Recruiting
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 305-674-2625, yenrique@msmc.com
Mike Cusnir
- Recruiting
Hartford HealthCare - Avon
Avon, Connecticut, 06001
Site Public Contact, 860-972-4700
Jaykumar T. Thumar
- Recruiting
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Christopher M. Reynolds
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Katherine M. Bever
- Active, not recruiting
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Edward S. James
- Recruiting
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425
Site Public Contact, 218-828-2880
Bret E. Friday
- Recruiting
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Mohammed N. Al Hallak
- Active, not recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Mridula Krishnan
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Suspended
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Suspended
Saint Charles Health System
Bend, Oregon, 97701
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Sarah Gillett
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu
Saima Sharif
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Saint Vincent Healthcare
Billings, Montana, 59101
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Karng S. Log
- Recruiting
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Site Public Contact, 800-648-6274
Karng S. Log
- Recruiting
Intermountain Health West End Clinic
Billings, Montana, 59106
Site Public Contact, 406-238-6685
Karng S. Log
- Active, not recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Suspended
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Schulze Family Foundation Cancer Clinic - Bonita Health Center
Bonita Springs, Florida, 34135
Site Public Contact, 239-343-9660, RCCR@leehealth.org
Leandro P. Moraes
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Site Public Contact, 617-638-8265
Gretchen A. Gignac
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Peter C. Enzinger
- Active, not recruiting
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
- Active, not recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Intermountain Health Platte Valley Hospital
Brighton, Colorado, 80601
Site Public Contact, peaksresearch@imail.org
Karng S. Log
- Recruiting
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, 02135
Site Public Contact, 617-789-2903
Alys Malcolm
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Site Public Contact, 718-780-3677, Adg9003@nyp.org
Uqba Khan
- Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
- Recruiting
Mills-Peninsula Medical Center
Burlingame, California, 94010
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Sarah Gillett
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Sarah Gillett
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Edward S. James
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Site Public Contact, 406-723-2621
Karng S. Log
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Suspended
Cambridge Medical Center
Cambridge, Minnesota, 55008
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Active, not recruiting
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
- Recruiting
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Active, not recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
- Active, not recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Eden Hospital Medical Center
Castro Valley, California, 94546
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Active, not recruiting
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
- Active, not recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Saint Mary's Hospital
Centralia, Illinois, 62801
- Suspended
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Ashwin Somasundaram
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Albert C. Lockhart
- Recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org
Ahmed A. Khalid
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Matthew J. Reilley
- Recruiting
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Daniel Lin
- Active, not recruiting
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
- Recruiting
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
John M. Schallenkamp
- Recruiting
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
Site Public Contact, 773-257-5960, suhi@sinai.org
Pam G. Khosla
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M. Tamkus
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Yolande Chen
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Manik A. Amin
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Edward S. James
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michael Husak
- Active, not recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
- Active, not recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Active, not recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
- Active, not recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
- Active, not recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Natasha C. Edwin
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Mohammed N. Al Hallak
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Recruiting
Trinity Health IHA Medical Group - Primary Care - Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 248-858-6215, Emily.Crofts@Trinity-Health.org
Christopher M. Reynolds
- Active, not recruiting
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Active, not recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
- Active, not recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
- Active, not recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
- Active, not recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
- Active, not recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Ning Jin
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
- Suspended
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Suspended
Grant Medical Center
Columbus, Ohio, 43215
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Mount Carmel Health Center West
Columbus, Ohio, 43222
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Doctors Hospital
Columbus, Ohio, 43228
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Suspended
Bay Area Hospital
Coos Bay, Oregon, 97420
- Active, not recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
- Recruiting
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, 92627
Site Public Contact, 877-827-8839
Farshid Dayyani
- Active, not recruiting
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Suspended
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503
- Suspended
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
- Recruiting
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota, 56442
Site Public Contact, 218-692-1010
Bret E. Friday
- Recruiting
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
Site Public Contact, 219-836-6879, CancerResearch@powershealth.org
Tanmay Sahai
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Manik A. Amin
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Edward S. James
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Edward S. James
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Victoria Chung
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Victoria Chung
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Victoria Chung
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Tanmay Sahai
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Ahmad Hanif
- Recruiting
Sutter Davis Hospital
Davis, California, 95616
Site Public Contact, NCIclinicaltrials@sutterhealth.org
Uma Suryadevara
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Site Public Contact, 248-551-7695
George S. Howard
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
- Suspended
Grady Memorial Hospital
Delaware, Ohio, 43015
- Recruiting
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204
Site Public Contact, 303-777-2663
Karng S. Log
- Recruiting
National Jewish Health-Main Campus
Denver, Colorado, 80206
Site Public Contact, 877-225-5654, glicht@co-cancerresearch.org
Karng S. Log
- Active, not recruiting
The Women's Imaging Center
Denver, Colorado, 80209
- Active, not recruiting
AdventHealth Porter
Denver, Colorado, 80210
- Active, not recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Active, not recruiting
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
- Active, not recruiting
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
- Recruiting
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
Site Public Contact, 303-318-3413
Karng S. Log
- Active, not recruiting
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
- Suspended
Rose Medical Center
Denver, Colorado, 80220
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Site Public Contact, 800-527-6266, ctoadmin@karmanos.org
Mohammed N. Al Hallak
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Christopher M. Reynolds
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu
Ahmad Hanif
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Edward S. James
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Tatjana Kolevska
- Suspended
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
- Suspended
Dublin Methodist Hospital
Dublin, Ohio, 43016
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
- Active, not recruiting
Mercy Medical Center
Durango, Colorado, 81301
- Recruiting
Northwest Oncology LLC
Dyer, Indiana, 46311
Site Public Contact, 219-924-8178
Tanmay Sahai
- Recruiting
Henry Ford River District Hospital
East China Township, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Christopher M. Reynolds
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michael Husak
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Suspended
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Tanmay Sahai
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Edward S. James
- Active, not recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Site Public Contact, 410-443-1360, frank.crum@christianacare.org
Gregory A. Masters
- Recruiting
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Site Public Contact, 218-365-7900
Bret E. Friday
- Suspended
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
- Active, not recruiting
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
- Active, not recruiting
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
- Suspended
Swedish Medical Center
Englewood, Colorado, 80113
- Active, not recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Providence Regional Cancer Partnership
Everett, Washington, 98201
- Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org
John M. Schallenkamp
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Arthur A. Winer
- Recruiting
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Arthur A. Winer
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Arthur A. Winer
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Sanford South University Medical Center
Fargo, North Dakota, 58103
Site Public Contact, 701-234-6161
Daniel Almquist
- Recruiting
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
Site Public Contact, 605-312-3320
Daniel Almquist
- Recruiting
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
Site Public Contact, 800-437-4010
Daniel Almquist
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Farmington Health Center
Farmington, Utah, 84025
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Christopher D. Nevala-Plagemann
- Recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Mohammed N. Al Hallak
- Recruiting
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
Site Public Contact, 248-551-7695
George S. Howard
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Active, not recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Active, not recruiting
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Mohammed N. Al Hallak
- Recruiting
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Jini Hyun
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Lynn M. Mathew
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Lynn M. Mathew
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Christopher M. Reynolds
- Recruiting
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Leandro P. Moraes
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Recruiting
Tarrant County Hospital District/JPS Health Network
Fort Worth, Texas, 76104
Site Public Contact, 817-702-5913, macosta02@jpshealth.org
Latha S. Neerukonda
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Victoria Chung
- Recruiting
Essentia Health - Fosston
Fosston, Minnesota, 56542
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
Site Public Contact, 877-338-7425
Naeem Tahir
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Tatjana Kolevska
- Recruiting
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Fresno Cancer Center
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Tatjana Kolevska
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Tatjana Kolevska
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Tatjana Kolevska
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Suspended
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
- Recruiting
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Active, not recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Edward S. James
- Recruiting
MyMichigan Medical Center Gladwin
Gladwin, Michigan, 48624
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Christopher M. Reynolds
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Sarah Gillett
- Recruiting
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, 80401
Site Public Contact, peaksresearch@imail.org
Karng S. Log
- Recruiting
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401
Site Public Contact, 303-777-2663, glicht@co-cancerresearch.org
Karng S. Log
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Edward S. James
- Active, not recruiting
CHI Health Saint Francis
Grand Island, Nebraska, 68803
- Recruiting
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org
Karng S. Log
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Christopher M. Reynolds
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
Puerto Rico7 sites, 7 recruiting
- Recruiting
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060
Site Public Contact, 787-395-7085
Luis J. Santos Reyes
- Recruiting
Puerto Rico Hematology Oncology Group
Bayamón, 00961
Site Public Contact, 787-780-2865
Luis J. Santos Reyes
- Recruiting
Doctors Cancer Center
Manati, 00674
Site Public Contact, 787-621-4397
Luis J. Santos Reyes
- Recruiting
San Juan Community Oncology Group
San Juan, 00917
Site Public Contact, 787-274-3387
Luis J. Santos Reyes
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Luis J. Santos Reyes
- Recruiting
PROncology
San Juan, 00927
Site Public Contact, 787-919-7919, info@PRoncology.com
Luis J. Santos Reyes
- Recruiting
San Juan City Hospital
San Juan, 00936
Site Public Contact, 787-763-1296
Luis J. Santos Reyes
About this study
Official title: Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma. The usual approach for patients who are not in a study is treatment with FOLFOX with some receiving an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX chemotherapy. The usual approach is defined as care most people get for cancer in the stomach, esophagus, or gastroesophageal junction. Fluorouracil is in a class of medications called antimetabolites. It stops cells from making DNA and may kill tumor cells. Leucovorin in a class of medications called folic acid analogs. When used with fluorouracil it enhances the effects of this chemotherapy drug. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair, and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Some patients on this trial will receive nivolumab, in addition to mFOLFOX or mFOLFIRINOX chemotherapy. mFOLFIRINOX with or without nivolumab may be more effective than mFOLFOX with or without nivolumab by shrinking the tumor in patients with advanced, unresectable, or metastatic HER2-negative esophageal, gastroesophageal junction, or gastric adenocarcinoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma.
SECONDARY OBJECTIVES:
- To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms.
II. To evaluate safety and tolerability associated with treatment in each of the treatment arms.
III. To evaluate the proportion of patients receiving second line of therapy in both arms.
IV. To evaluate tolerability of the treatment in both arms using Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE).
EXPLORATORY OBJECTIVES:
- Exploratory correlative markers will also be measured and evaluated within and between arms to better assess mechanisms and prognostic impact of markers on impact. These will include baseline PD-L1 combined positive score (CPS) and cell free deoxyribonucleic acid (cfDNA) before and after treatment.
II. To evaluate and assess the feasibility and compliance associated with not centrally collecting perceived attribution of protocol treatment to reported adverse events.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive fluorouracil intravenously (IV), leucovorin calcium IV, oxaliplatin IV, and irinotecan IV on study and nivolumab IV as clinically indicated. Patients undergo magnetic resonance imaging (MRI) and a computed tomography (CT) scan throughout the trial. Patients may also undergo blood sample collection on study.
ARM II: Patients receive fluorouracil IV, leucovorin calcium IV, and oxaliplatin IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.
- Conditions
- Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Being tested
- Fluorouracil, Leucovorin Calcium, Oxaliplatin, Irinotecan, Nivolumab
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
Also called 2,4-Dioxo-5-fluoropyrimidine, 5 Fluorouracil, 5 Fluorouracilum, 5 FU
Given IV
Also called 1492-18-8, 5-Formyl Tetrahydrofolate, Calcium (6S)-Folinate, Calcium Folinate
Given IV
OxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, ELOXATIN
Given IV
IrinotecanDrug
Given IV
NivolumabBiological
Also called MDX-1106, Opdivo
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called MRI
Undergo MRI
Computed TomographyProcedure or surgery
Also called CAT Scan, Computed Axial Tomography, CT Scan
Undergo a CT Scan
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (mFOLFIRINOX, nivolumab) | Experimental | Patients receive fluorouracil IV over 44-46 hours on day 1 of each cycle, leucovorin calcium as bolus injection or IV infusion over 10-120 minutes on day 1 of each cycle, oxaliplatin IV over 2-6 hours on day 1 for up to 12 cycles, and irinotecan IV over 90 minutes on day 1 of each cycle. Patients may also receive nivolumab IV over 30 minutes on day 1 of each cycle as clinically indicated. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study. Receives: Drug: Fluorouracil; Drug: Leucovorin Calcium; Drug: Oxaliplatin; Drug: Irinotecan; Biological: Nivolumab; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Questionnaire Administration |
| Arm II (mFOLFOX, nivolumab) | Active comparator | Patients receive fluorouracil IV bolus and IV infusion over 44-46 hours on day 1 of each cycle, leucovorin calcium as bolus injection or IV infusion over 10-120 minutes on day 1 of each cycle, and oxaliplatin IV over 2-6 hours on day 1 for up to 12 cycles. Patients may also receive nivolumab IV over 30 minutes on day 1 of each cycle as clinically indicated. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study. Patients are followed every 6 months until 3 years following registration, or at the time of tumor progression, withdrawal or removal from the study. Receives: Drug: Fluorouracil; Drug: Leucovorin Calcium; Drug: Oxaliplatin; Biological: Nivolumab; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Will compare the distributions of OS between the two treatment arms to determine if patients treated with modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) (with or without nivolumab) have an OS benefit compared to those treated with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) (with or without nivolumab). Kaplan-Meier methodology will be used to estimate the distributions for the treatment arms. To compare the OS distributions between the two treatment arms, we will use a one-sided logrank test to evaluate if mFOLFIRINOX (with or without nivolumab) is superior to mFOLFOX (with or without nivolumab) based on an intention to treat analysis. The hazard ratio, median OS, and estimated OS rates at 1 and 2 years will be estimated along with corresponding 95% confidence intervals. Multivariable Cox proportional hazards models will also be used to assess the impact of treatment arm on OS when stratifying on the stratification factors.
Measured: Up to 2 years from the time of randomization.
Secondary outcomes (5)
Progression-free survival (PFS)
PFS will be evaluated as a time to event outcome and compared in a secondary manner between the two treatment arms. Patients who are alive and progression-free at their last evaluation will be censored at that time point.
Measured: The time from registration to the time of documented progression and/or death, assessed up to 3 years
Overall response rate
The best response achieved after initiation of therapy on protocol will also be assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and will be summarized by treatment arm. The overall response rate will be calculated as the number of patients who achieve a response (partial response, complete response) divided by the total number of patients randomized to the corresponding treatment arm.
Measured: Up to 3 years
Duration of Response
Measured: The time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 3 years
Incidence of adverse events
The toxicity and tolerability of each of these regimens will be evaluated and captured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5, where the type and severity grade of each adverse event will be collected and tabulated within each of the treatment arms. Perceived attribution to study treatment will also be captured. Tolerability will further be assessed by summarizing the numbers of patients who require dose modifications or delays, and reasons for patients to go off treatment.
Measured: Up to 3 years
Patient reported outcomes
Patient-reported side effect assessments (Patient Reported Outcomes [PRO]-CTCAE) will also be collected before and during therapy and will be summarized within and compared between treatment arms. To evaluate between-arm differences in patient-reported symptomatic adverse events as assessed by the PRO-CTCAE, the frequency and proportion of patients with a maximum post-baseline score greater than 0 will be compared across arms using a chi^2 test or Fisher's exact test with a nominal significance level of alpha = 0.10. Similarly, the frequency and proportion of patients with a maximum post-baseline score greater than or equal to 3 will be compared across arms using a chi^2 test or Fisher's exact test with a nominal significance level of alpha = 0.10.
Measured: At baseline, day 1 of cycles 1-8 and day 1 of each odd-numbered cycle thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start31 Jan 2023
- Primary completion8 Nov 2028 (estimated)
- Study completion8 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677490
- Sponsor's protocol ID
- A022102
- Other IDs
- NCI-2022-08569
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No