AzTrials
AzTrials

Colorectal CancerPhase 3NCT01150045

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

A Phase 3 study testing celecoxib, 5-fluorouracil and oxaliplatin in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 842 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
celecoxib, 5-fluorouracil and oxaliplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,527 participants
Where
842 sitesin 3 countries
Study dates
Jun 2010to 11 Aug 2022
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
  1. Requirements for tumor parameters
  2. Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection (i.e., patients with rectal cancer are not eligible). Surgeon confirmation that the entire tumor was above the peritoneal reflection is only required in cases where it is important to establish if the tumor is a rectal or colon primary.
  3. Tumors must have been completely resected. In patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon. Near or positive radial margin are not exclusions as long as en bloc resection was performed. Positive proximal margin or distal margin is an exclusion.
  4. Node positive disease (N1 or N2) as designated in AJCC version 7. Either at least one pathologically confirmed positive lymph node or N1C (defined as tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases). Patients with resected stage IV disease are not eligible.
  5. No evidence of residual involved lymph node disease or metastatic disease at the time of registration.
  6. Patients with synchronous colon cancers are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor. However, patients with synchronous colon and rectal primary tumors are not eligible.
  7. NSAID use Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average. Low-dose aspirin not exceeding 100 mg/day is permitted. Patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no was out period is required.
  8. Patient history
  9. No previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or any other cancer for which the patient has been disease-free for at least 5 years.
  10. No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration.
  11. No known allergy to platinum compounds.
  12. No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs.
  13. No history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Patients with ulceration, bleeding or perforation in the lower bowel are not excluded.
  14. No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2.
  15. No cardiac risk factors including:
  • Uncontrolled high blood pressure (systolic blood pressure > 150).
  • Unstable angina.
  • History of documented myocardial infarction or cerebrovascular accident.
  • New York Heart Association class III or IV heart failure.
  1. Pregancy/nursing status Non-pregnant and not nursing. Men and women of childbearing potential must agree to employ adequate contraception for the duration of chemotherapy and for as many as 8 weeks after the completion of chemotherapy due to the unknown teratogenic effects of FOLFOX on the developing fetus.
  2. Age and performance status
  3. ECOG performance status 0, 1 or 2.
  4. Age at least 18 years.
  5. Required initial laboratory values
  6. Granulocytes ≥ 1,500/μL
  7. Platelet count ≥ 100,000/μL
  8. Creatinine ≤ 1.5 times upper limit of normal (ULN)
  9. Total Bilirubin ≤ 1.5 times ULN in the absence of Gilbert's disease
  10. Direct bilirubin ≤ 1.5 x upper limit of normal for patients with Gilbert's syndrome

Trial locations and contacts

842 sites in 3 countries.

316 sites in 3 countries

United States300 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Avera Saint Luke's Hospital and Cancer Center

    Aberdeen, South Dakota, 57401

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Toledo Clinic Cancer Centers - Adrian

    Adrian, Michigan, 49221

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Lovelace Medical Center - Downtown

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Lovelace Medical Center at Lovelace Sandia Health System

    Albuquerque, New Mexico, 87108

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0912

  • Fox Valley Hematology and Oncology

    Appleton, Wisconsin, 54911-3496

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Mountain Radiation Oncology

    Asheville, North Carolina, 28801

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • University of Colorado Cancer Center-Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Rush Copley Medical Center

    Aurora, Illinois, 60504-4206

  • Virginia Mason Bainbridge Island Medical Center

    Bainbridge Island, Washington, 98110

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21133

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Cleveland Clinic Cancer Center Beachwood

    Beachwood, Ohio, 44122

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Clinic North-Bemidji

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Central Vermont Medical Center

    Berlin Corners, Vermont, 05602

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Hematology Oncology Associates - Quad Cities

    Bettendorf, Iowa, 52722

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Central Care Cancer Center - Carrie J Babb Cancer Center

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Transylvania Regional Hospital

    Brevard, North Carolina, 28612

  • Eastern Maine Medical Center Cancer Care

    Brewer, Maine, 04412

  • Wellmont Medical Associates-Oncology and Hematology

    Bristol, Tennessee, 37620

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center-Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Mills-Peninsula Hospitals

    Burlingame, California, 94010

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Aurora Cancer Care-Burlington

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52403

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Northwestern University

    Chicago, Illinois, 60611

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • University of Illinois

    Chicago, Illinois, 60612

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Presence Saint Joseph Hospital-Chicago

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Oncology Hematology Care Inc-Eden Park

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care Inc-Mercy West

    Cincinnati, Ohio, 45211

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Anderson

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Oncology Hematology Care Inc-Blue Ash

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Siteman Cancer Center - Saint Peters

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Oncology and Hematology Care Southeast

    Clackamas, Oregon, 97015

  • Case Western Reserve Center

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Memorial Hospital Colorado Springs

    Colorado Springs, Colorado, 80909

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel Hospital East

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Doctors Hospital

    Columbus, Ohio, 43228

  • John Muir Medical Center-Concord

    Concord, California, 95420

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Baptist Health Corbin

    Corbin, Kentucky, 40704

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Ochsner Health Center - Covington

    Covington, Louisiana, 70433

  • Oncology Hematology Care Inc-Crestview

    Crestview Hills, Kentucky, 41017

  • Michiana Hematology Oncology PC-Crown Point

    Crown Point, Indiana, 46307

  • Western Maryland Regional Medical Center

    Cumberland, Maryland, 21502

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Sutter Davis Hospital

    Davis, California, 95616

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45420

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian-Saint Lukes Medical Center-Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program NCORP

    Denver, Colorado, 80222

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80907

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates - Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Wentworth Douglass Hospital

    Dover, New Hampshire, 03820

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Epic Care-Dublin

    Dublin, California, 94568

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Veterans Administration New Jersey Health Care System

    East Orange, New Jersey, 07018

  • Easton Hospital

    Easton, Pennsylvania, 18042

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System Eau Claire Hospital-Luther Campus

    Eau Claire, Wisconsin, 54703

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Medical Center-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Hardin Memorial Hospital

    Elizabethtown, Kentucky, 42701

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Aurora Cancer Care-Southern Lakes

    Elkhorn, Wisconsin, 53121

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Comprehensive Cancer Care and Research Institute of Colorado LLC

    Englewood, California, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Green Bay Oncology-Escanaba

    Escanaba, Michigan, 49431

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Medical Oncology Hematology Associates of Northern Virginia Limited

    Fairfax, Virginia, 22031

  • JCHC McCreery Cancer Center

    Fairfield, Iowa, 52556

  • Oncology Hematology Care Inc-Healthplex

    Fairfield, Ohio, 45014

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58102

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Botsford Hospital

    Farmington, Michigan, 48336

  • Virginia Mason Federal Way Medical Center

    Federal Way, Washington, 98002

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • IU Health Central Indiana Cancer Centers-Fishers

    Fishers, Indiana, 46037

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • MetroWest Medical Center-Framingham Union Hospital

    Framingham, Massachusetts, 01702

  • Angel Medical Center

    Franklin, North Carolina, 28744

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • University Oncology Associates

    Fresno, California, 93701

  • California Cancer Center - North Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • University of Florida-Gainesville

    Gainesville, Florida, 32610-0277

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Kaiser Permanente - Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Tacoma/Valley Radiation Oncology Centers-Gig Harbor

    Gig Harbor, Washington, 98332

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare - Sletten Cancer Institute

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Marin General Hospital

    Greenbrae, California, 94904

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Health System Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Gulfport Memorial Hospital

    Gulfport, Mississippi, 39502

  • Meritus Medical Center

    Hagerstown, Maryland, 21742

  • Virginia Oncology Associates - Hampton

    Hampton, Virginia, 23666

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17105

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hays Medical Center

    Hays, Kansas, 67601

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • 21st Century Oncology-Henderson

    Henderson, Nevada, 89074

Other trials in United States

Canada15 sites

  • Cambridge Memorial Hospital

    Cambridge, Ontario, N1R 3G2

  • PEI Cancer Treatment Centre-Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • BCCA-Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Niagara Health System-Saint Catharines General

    Saint Catharines, Ontario, ON L2S 0A9

  • Horizon Health Network-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Puerto Rico1 site

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer

PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.

Read the detailed description

OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more information. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. The primary and secondary objectives for the research study are described below.

Primary objective:

  1. To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib 400 mg daily.

Secondary objectives:

  1. To contribute to an international prospective pooled analysis that will compare disease-free survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
  2. To compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.
  3. To contribute to an international prospective pooled analysis that will compare overall survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
  4. To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage III colon cancer.
  5. To assess differences in cardiovascular-specific events with celecoxib versus placebo in a population of stage III colon cancer survivors.
  6. To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, for patients treated with 6 treatments of FOLFOX compared to those treated with 12 treatments of FOLFOX.

After completion of study therapy, patients are followed up every 6 months for up to 6 years.

Being tested
celecoxib, 5-fluorouracil, placebo, oxaliplatin, leucovorin
Keywords
adenocarcinoma of the colon, stage III colon cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • celecoxibDrug

    Patients receive celecoxib 400 mg administered by mouth, once daily.

  • 5-fluorouracilDrug

    Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours.

  • placeboOther

    Patients receive placebo administered by mouth, once daily.

  • oxaliplatinDrug

    Patients receive 85 mg/m^2 intravenous over two hours.

  • leucovorinDrug

    Patients receive 400 mg/m^2 intravenous over two hours.

Study groups in NCT01150045
Study groupRoleWhat they receive
Arm A - FOLFOX and placebo (12 treatments)Active comparatorPatients receive FOLFOX every 2 weeks plus placebo every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.
Receives: Drug: 5-fluorouracil; Other: placebo; Drug: oxaliplatin; Drug: leucovorin
Arm B - FOLFOX and celecoxib (12 treatments)ExperimentalPatients receive FOLFOX every 2 weeks plus celecoxib every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.
Receives: Drug: celecoxib; Drug: 5-fluorouracil; Drug: oxaliplatin; Drug: leucovorin
Arm C - FOLFOX and placebo (6 treatments)Active comparatorPatients receive FOLFOX every 2 weeks plus placebo every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.
Receives: Drug: 5-fluorouracil; Other: placebo; Drug: oxaliplatin; Drug: leucovorin
Arm D - FOLFOX and celecoxib (6 treatments)ExperimentalPatients receive FOLFOX every 2 weeks plus celecoxib every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.
Receives: Drug: celecoxib; Drug: 5-fluorouracil; Drug: oxaliplatin; Drug: leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    Disease-Free Survival (DFS) is defined as the time of randomization until documented progression or death from any cause. The endpoint of this trial is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive and disease free after 3 years are reported here. A log-rank test stratified with the stratification factors was used to compare disease-free survival (celecoxib vs placebo)

    Measured: At 3 years of follow-up

Secondary outcomes (1)

  1. Overall Survival

    Overall Survival (DFS) is defined as the time of randomization until documented death from any cause. The endpoint is to compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 5 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive after 3 years are reported here.

    Measured: up to 3 years from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completion28 Feb 2020
  4. Study completion11 Aug 2022

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
2,527 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01150045
Sponsor's protocol ID
CALGB-80702
Other IDs
U10CA031946, CALGB-80702, CDR0000675693
Status last verified
Apr 2026
First submitted
23 Jun 2010
Last updated
19 May 2026
Data monitoring committee
Yes

Publications

  • Lee S, Ma C, Shi Q, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Tan B, Shergill A, O'Reilly EM, Shields AF, Meyerhardt JA. Flavonoids and survival in stage III colon cancer: CALGB/SWOG 80702 (alliance). JNCI Cancer Spectr. 2026 Oct 21:pkag112. doi: 10.1093/jncics/pkag112. Online ahead of print.

    PubMed 42902778

  • Zhang GQ, Meyerhardt JA, Shi Q, Twombly T, Pederson L, Ma C, Vayrynen JP, Zhao M, Takashima Y, Shergill A, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Tan B, O'Reilly EM, Giannakis M, Ogino S, Jurdi A, Sharma S, Aleshin A, Shields AF, Nowak JA. Predictive Role of Circulating Tumor DNA in Stage III Colon Cancer Treated With Celecoxib: A Post Hoc Analysis of the CALGB (Alliance)/SWOG 80702 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Feb 1;12(2):149-158. doi: 10.1001/jamaoncol.2025.5144.

    PubMed 41343176

  • Nowak JA, Twombly T, Ma C, Shi Q, Haruki K, Fujiyoshi K, Vayrynen J, Zhao M, Knight J, Mane S, Shergill A, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Tan B, Philip P, O'Reilly EM, Shields AF, Ogino S, Fuchs CS, Meyerhardt JA. Improved Survival With Adjuvant Cyclooxygenase 2 Inhibition in PIK3CA-Activated Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance). J Clin Oncol. 2024 Aug 20;42(24):2853-2859. doi: 10.1200/JCO.23.01680. Epub 2024 Jun 18.

    PubMed 38889377

  • Lee S, Ma C, Shi Q, Meyers J, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, O'Reilly EM, Shields AF, Meyerhardt JA. Sleep and cancer recurrence and survival in patients with resected Stage III colon cancer: findings from CALGB/SWOG 80702 (Alliance). Br J Cancer. 2023 Aug;129(2):283-290. doi: 10.1038/s41416-023-02290-2. Epub 2023 May 13.

    PubMed 37179438

  • Cheng E, Shi Q, Shields AF, Nixon AB, Shergill AP, Ma C, Guthrie KA, Couture F, Kuebler P, Kumar P, Tan B, Krishnamurthi SS, Ng K, O'Reilly EM, Brown JC, Philip PA, Caan BJ, Cespedes Feliciano EM, Meyerhardt JA. Association of Inflammatory Biomarkers With Survival Among Patients With Stage III Colon Cancer. JAMA Oncol. 2023 Mar 1;9(3):404-413. doi: 10.1001/jamaoncol.2022.6911.

    PubMed 36701146

  • Lee S, Ma C, Shi Q, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF, Meyerhardt JA. Potential Mediators of Oxaliplatin-Induced Peripheral Neuropathy From Adjuvant Therapy in Stage III Colon Cancer: Findings From CALGB (Alliance)/SWOG 80702. J Clin Oncol. 2023 Feb 10;41(5):1079-1091. doi: 10.1200/JCO.22.01637. Epub 2022 Nov 11.

    PubMed 36367997

  • Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

    PubMed 36306483

  • Meyerhardt JA, Shi Q, Fuchs CS, Meyer J, Niedzwiecki D, Zemla T, Kumthekar P, Guthrie KA, Couture F, Kuebler P, Bendell JC, Kumar P, Lewis D, Tan B, Bertagnolli M, Grothey A, Hochster HS, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1277-1286. doi: 10.1001/jama.2021.2454.

    PubMed 33821899

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