Adenocarcinoma of the ColonPhase 3NCT00079274
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
A Phase 3 study testing irinotecan hydrochloride, oxaliplatin and leucovorin calcium in people with Adenocarcinoma of the Colon and Stage III Colon Cancer, run by National Cancer Institute (NCI) at 894 sites in 3 countries.
Trial summary
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adenocarcinoma of the Colon, Stage III Colon Cancer
- What is being tested?
- irinotecan hydrochloride, oxaliplatin and leucovorin calcium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,397 participants
- Where
- 894 sitesin 3 countries
- Study dates
- Feb 2004to Nov 2012
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the colon
- Stage III disease
- No resected stage IV disease
- No rectal cancer
- Gross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the anal verge by rigid proctoscopy
- Stage III tumor must have been completely resected within the past 56 days
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- Must have documented en bloc resection in patients with tumor adherence to adjacent structures
- Tumor-related obstructions and colonic perforation are allowed
- Tumor samples must be available
- At least 1 pathologically confirmed positive lymph node
- No evidence of residual involved lymph node disease
- Synchronous primary colon cancer allowed
- No distant metastatic disease
- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- No uncontrolled high blood pressure
- No unstable angina
- No symptomatic congestive heart failure
- No myocardial infarction with the past 6 months
- No New York Heart Association class III or IV heart disease
- No symptomatic pulmonary fibrosis
- No symptomatic interstitial pneumonitis
- No prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy
- No known allergy to platinum compounds
- No documented presence of human anti-mouse antibodies (HAMA)
- No active uncontrolled bacterial, viral, or systemic fungal infection
- HIV negative
- No clinically defined AIDS
- Not pregnant or nursing
- Negative pregnancy test
- No men or women of childbearing potential who are unwilling to employ adequate contraception
- No inadequately treated gastrointestinal bleeding
- No ≥ grade 2 pre-existing peripheral sensory or motor neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or lobular carcinoma in situ in 1 breast
- No other concurrent medical condition that would preclude study participation
- No concurrent biologic therapy
- No prior chemotherapy for colon cancer
- No other concurrent chemotherapy
- No prior radiotherapy for colon cancer
- No concurrent targeted agents
- No prior agents directed against epidermal growth factor-receptor
- No other concurrent anticancer therapy
Who cannot join
None listed.
Trial locations and contacts
894 sites in 3 countries.
336 sites in 3 countries
United States300 sites
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701
Conklin Regional Cancer Center
Aberdeen, South Dakota, 57401
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Bixby Medical Center
Adrian, Michigan, 49221
Hickman Cancer Center
Adrian, Michigan, 49221
Akron City Hospital
Akron, Ohio, 44304
Akron General Medical Center
Akron, Ohio, 44307
Phoebe Putney Memorial Hospital
Albany, Georgia, 31703
University of New Mexico at Lovelace Medical Center
Albuquerque, New Mexico, 87102
Hematology Oncology Associates
Albuquerque, New Mexico, 87106
University of New Mexico
Albuquerque, New Mexico, 87106
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Harris, John Gilbert MD (UIA Investigator)
Alexandria, Minnesota, 56308
Medini, Eitan MD (UIA Investigator)
Alexandria, Minnesota, 56308
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
Saint Anthony's Health
Alton, Illinois, 62002
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
McFarland Clinic
Ames, Iowa, 50010
Providence Alaska Medical Center
Anchorage, Alaska, 99508
AnMed Health Hospital
Anderson, South Carolina, 29621
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36202
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Memorial Hospital of Arkansas City
Arkansas City, Kansas, 67005
Mission Hospitals Inc
Asheville, North Carolina, 28801
Our Lady Bellefonte Hospital
Ashland, Kentucky, 41101
Piedmont Hospital
Atlanta, Georgia, 30309
Atlanta Regional CCOP
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
Auburn Regional Medical Center
Auburn, Washington, 98002
Augusta Oncology Associates PC
Augusta, Georgia, 30901
The Medical Center of Aurora
Aurora, Colorado, 80012
Rush - Copley Medical Center
Aurora, Illinois, 60504
Well Star Cobb Hospital
Austell, Georgia, 30106
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
The Union Memorial Hospital
Baltimore, Maryland, 21218
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Good Samaritan Hospital of Maryland
Baltimore, Maryland, 21239
Johns Hopkins University
Baltimore, Maryland, 21287-8936
Eastern Maine Medical Center
Bangor, Maine, 04401
Summa Barberton Hospital
Barberton, Ohio, 44203
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, 70809
Battle Creek Health System
Battle Creek, Michigan, 49017
Bay Regional Medical Center
Bay City, Michigan, 48708
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107
Mary Rutan Hospital
Bellefontaine, Ohio, 43311
Saint Joseph Hospital
Bellingham, Washington, 98225
Merit Care Clinic Bemidji
Bemidji, Minnesota, 56601
Southwestern Oncology Research Department
Bennington, Vermont, 05201
Highlands Oncology Group-Bentonville
Bentonville, Arkansas, 72712
Alta Bates Medical Center-Herrick Campus
Berkeley, California, 94704
Saint Luke's Hospital
Bethlehem, Pennsylvania, 18015
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, 52722
Beverly Hospital
Beverly, Massachusetts, 01915
Mecosta County Medical Center
Big Rapids, Michigan, 49307
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59101
Montana Cancer Consortium CCOP
Billings, Montana, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Billings Clinic
Billings, Montana, 59107-7000
Deaconess Medical Center
Billings, Montana, 59107
Bismarck Cancer Center
Bismarck, North Dakota, 58501
Medcenter One Health Systems
Bismarck, North Dakota, 58501
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, 58501
Saint Joseph Medical Center
Bloomington, Illinois, 61701
The Boardman Cancer Center
Boardman, Ohio, 44512
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Boulder Community Hospital
Boulder, Colorado, 80301
Wood County Oncology Center
Bowling Green, Ohio, 43402
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Internal Medicine of Bozeman
Bozeman, Montana, 59715
Brainerd Medical Center Inc
Brainerd, Minnesota, 56401
Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Harrison Bremerton Hematology and Oncology
Bremerton, Washington, 98310
Ocean Medical Center
Brick, New Jersey, 08724
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Caritas Saint Elizabeth's Medical Center
Brighton, Massachusetts, 02135-2997
Long Island College Hospital
Brooklyn, New York, 11201
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Veterans Affairs Western New York Health Care System-Buffalo
Buffalo, New York, 14215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence Saint Joseph Medical Center
Burbank, California, 91505
Mills - Peninsula Hospitals
Burlingame, California, 94010
Alamance Regional Medical Center
Burlington, North Carolina, 27216
University of Vermont
Burlington, Vermont, 05401
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
Graham Hospital Association
Canton, Illinois, 61520
Mercy Medical Center
Canton, Ohio, 44708
Aultman Health Foundation
Canton, Ohio, 44710
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Marion Community Hospital
Carbondale, Pennsylvania, 18407
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Memorial Hospital
Carthage, Illinois, 62321
East Bay Radiation Oncology Center
Castro Valley, California, 94546
Eden Hospital Medical Center
Castro Valley, California, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546
Iowa Blood and Cancer Care PLC
Cedar Rapids, Iowa, 52402
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, 52403
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates
Cedar Rapids, Iowa, 52403
Providence Centralia Hospital
Centralia, Washington, 98531
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Medical Center
Charlotte, North Carolina, 28203
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
Hematology and Oncology Associates
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612-3785
Mercy Hospital and Medical Center
Chicago, Illinois, 60616
Swedish Covenant Hospital
Chicago, Illinois, 60625
Resurrection Healthcare
Chicago, Illinois, 60631
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470
Weiss Memorial Hospital
Chicago, Illinois, 60640
Illinois Masonic Medical Center
Chicago, Illinois, 60657
Adena Regional Medical Center
Chillicothe, Ohio, 54601
Case Western Reserve University
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, 80909
Missouri Cancer Associates
Columbia, Missouri, 65201
John B Amos Cancer Center
Columbus, Georgia, 31904
Ohio State University Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Columbus CCOP
Columbus, Ohio, 43215
Grant Medical Center
Columbus, Ohio, 43215
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
New Hampshire Oncology-Hematology PA
Concord, New Hampshire, 03301
Mercy Hospital
Coon Rapids, Minnesota, 55433
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
Bay Area Hospital
Coos Bay, Oregon, 97420
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Hematology and Oncology Associates of Rhode Island Inc
Cranston, Rhode Island, 02920
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
Danbury Hospital
Danbury, Connecticut, 06810
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
Danville Regional Medical Center
Danville, Virginia, 24541
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023-1291
Genesis Medical Center - East Campus
Davenport, Iowa, 52803
Genesis Medical Center - West Campus
Davenport, Iowa, 52804
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Samaritan North Health Center
Dayton, Ohio, 45415
Veteran Affairs Medical Center
Dayton, Ohio, 45428
Dayton CCOP
Dayton, Ohio, 45429
Halifax Medical Center-Centers for Oncology
Daytona Beach, Florida, 32114
Oakwood Hospital
Dearborn, Michigan, 48123
Dekalb Medical Center
Decatur, Georgia, 30033
Veterans Administration Medical Center
Decatur, Georgia, 30033
Decatur Memorial Hospital
Decatur, Illinois, 62526
North Broward Medical Center
Deerfield Beach, Florida, 33064
Grady Memorial Hospital
Delaware, Ohio, 43015
Saint Anthony Central Hospital
Denver, Colorado, 80204
Porter Adventist Hospital
Denver, Colorado, 80210
Exempla Saint Joseph Hospital
Denver, Colorado, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Rose Medical Center
Denver, Colorado, 80220
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522
Columbia Parkland Medical Center
Derry, New Hampshire, 03038
Mercy Capitol
Des Moines, Iowa, 50307
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Wayne State University
Detroit, Michigan, 48202
Saint John Hospital and Medical Center
Detroit, Michigan, 48236
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
Bayhealth Medical Center at Kent General
Dover, Delaware, 19901
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
City of Hope
Duarte, California, 91010
Finley Hospital
Dubuque, Iowa, 52001
Duluth Clinic CCOP
Duluth, Minnesota, 55805
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805
Saint Mary's Medical Center
Duluth, Minnesota, 55805
Michigan State University - Breslin Cancer Center
East Lansing, Michigan, 48824-1313
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
Easton Hospital
Easton, Pennsylvania, 18042
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701
Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Midelfort Clinic-Clairemont Campus
Eau Claire, Wisconsin, 54702
Mayo Clinic Health System Eau Claire Hospital - Luther Campus
Eau Claire, Wisconsin, 54703
Fairview-Southdale Hospital
Edina, Minnesota, 55435
Saint Anthony Memorial Hospital
Effingham, Illinois, 62401
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
The Center for Integrative Cancer Medicine
El Paso, Texas, 79902
Sherman Hospital
Elgin, Illinois, 60123
Cancer Institute at Alexian Brothers
Elk Grove Village, Illinois, 60007
Elkhart General Hospital
Elkhart, Indiana, 46515
Union Hospital of Cecil County
Elkton, Maryland, 21921
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035
Swedish Medical Center
Englewood, Colorado, 80110
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49431
Eureka Hospital
Eureka, Illinois, 61530
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, 60201
Saint Francis Hospital
Evanston, Illinois, 60202
Exeter Hospital
Exeter, New Hampshire, 03833
Northbay Cancer Center
Fairfield, California, 94533
Veterans Administration Medical Center
Fargo, North Dakota, 58102
Innovis Health South University
Fargo, North Dakota, 58103
Meritcare Hospital
Fargo, North Dakota, 58122
MeritCare Medical Group
Fargo, North Dakota, 58122
Saint Francis Hospital
Federal Way, Washington, 98003
Etzell, Paul S MD (UIA Investigator)
Fergus Falls, Minnesota, 56537
Swenson, Wade II, MD (UIA Investigator)
Fergus Falls, Minnesota, 56537
Blanchard Valley Hospital
Findlay, Ohio, 45840
Hunterdon Medical Center
Flemington, New Jersey, 08822
Hurley Medical Center
Flint, Michigan, 48502
Genesys Regional Medical Center
Flint, Michigan, 48532
McLaren Regional Medical Center
Flint, Michigan, 48532
Central Wisconsin Cancer Program
Fond du Lac, Wisconsin, 54935
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Front Range Cancer Specialists
Fort Collins, Colorado, 80528
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Saint Edward Mercy Medical Center
Fort Smith, Arkansas, 72903
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
Fort Wayne, Indiana, 46845
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Frederick Memorial Hospital
Frederick, Maryland, 21701
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401
CentraState Medical Center
Freehold, New Jersey, 07728
Kaiser Permanente, Fremont
Fremont, California, 94538
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538
Fremont Area Medical Center
Fremont, Nebraska, 68025
Fremont Memorial Hospital
Fremont, Ohio, 43420
California Cancer Center - North Fresno
Fresno, California, 93720
Cancer Care Associates
Fresno, California, 93720
Unity Hospital
Fridley, Minnesota, 55432
University of Florida
Gainesville, Florida, 32610
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Galesburg Clinic
Galesburg, Illinois, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, 61401
Intercommunity Cancer Center
Galesburg, Illinois, 61401
University of Texas Medical Branch
Galveston, Texas, 77555-0565
Gaston Memorial Hospital
Gastonia, North Carolina, 28054
Banner Thunderbird Medical Center
Glendale, Arizona, 85306
Adirondack Cancer Center
Glens Falls, New York, 12801
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Riverside Middle Peninsula Cancer Center
Gloucester, Virginia, 23061
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534
Altru Cancer Center
Grand Forks, North Dakota, 58201
Saint Francis Medical Center
Grand Island, Nebraska, 68803
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Saint Mary's Health Care
Grand Rapids, Michigan, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Spectrum Health-Blodgett Campus
Grand Rapids, Michigan, 49506
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405
Big Sky Oncology
Great Falls, Montana, 59405
Great Falls Clinic
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, 54311-6519
California Cancer Care - Greenbrae
Greenbrae, California, 94904
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904
Franklin Medical Center
Greenfield, Massachusetts, 01301
Wayne Hospital
Greenville, Ohio, 45331
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Greenville CCOP
Greenville, South Carolina, 29615
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
Washington County Hospital
Hagerstown, Maryland, 21740
Cancer Institute of New Jersey At Hamilton
Hamilton, New Jersey, 08690
Catskill Regional Medical Center
Harris, New York, 12742
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, 17110
Canada31 sites
The Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
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
Regional Cancer Program of The Hopital Regional de Sudbury Regional Hopital
Greater Sudbury, Ontario, P3E 5J1
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, N2G 1G3
London Regional Cancer Program
London, Ontario, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7
Ottawa Health Research Institute-General Division
Ottawa, Ontario, K1H 1C4
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Algoma District Cancer Program Sault Area Hospital
Sault Ste. Marie, Ontario, P6A 3C4
Niagara Health System-Saint Catharines General
St. Catharines, Ontario, L2R 2Z7
BCCA-Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, P7B 6V4
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Trillium Health Centre-West Toronto
Toronto, Ontario, M9C 1A5
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Puerto Rico5 sites
Andres Grillasca Hospital
Ponce, 00733
Hato Rey Hematology Oncology Group
San Juan, 00917
I Gonzales Martinez-Oncologic Hospital
San Juan, 00919
San Juan Veterans Affairs Medical Center
San Juan, 00921-3201
San Juan City Hospital
San Juan, 00928
About this study
Official title: A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.
Read the detailed description
PRIMARY OBJECTIVES:
- Disease-free Survival (Arms A and D: Wild-type KRAS Patients)
SECONDARY OBJECTIVES:
- Disease-free Survival (Arms A and D: Mutant KRAS Patients) II. Disease-free Survival III. Overall Survival IV. Toxicity
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to positive lymph node involvement (1-3 vs 4 or more), histology (high [poorly differentiated or undifferentiated] vs low [well to moderately differentiated]), and clinical T stage (T1 or T2 vs T3 vs T4). Patients are randomized to 1 of 6 treatment arms (as of 6/1/2005, patients are randomized to treatment arms I and IV only; arms II, III, V, and VI are closed to accrual). As of 8/18/2008, pre-screening for KRAS status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D.
ARM A: Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
ARM B (closed to accrual as of 6/1/2005--currently enrolled patients may cross over to arm I for remainder of therapy): Patients receive irinotecan hydrochloride IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
ARM C (closed to accrual as of 6/1/2005--currently enrolled patients may cross over to arm I for remainder of therapy): Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
ARM D: Patients receive cetuximab* IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
ARM E (closed to accrual as of 6/1/2005--currently enrolled patients may cross over to arm D for remainder of therapy): Patients receive cetuximab* as in arm D and irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
ARM F (closed to accrual as of 6/1/2005--currently enrolled patients may cross over to arm D for remainder of therapy): Patients receive cetuximab* as in arm D and chemotherapy as in arm C.
ARM G (added as of 8/18/2008, mutant KRAS (or KRAS not evaluable) patients): Locally directed therapy.
NOTE: *Cetuximab is administered over 2 hours at a higher dose on day 1 of course 1 only.
Quality of life (QOL) is assessed at baseline, 3 months, and at the end of therapy. As of 8/18/2008, QOL was discontinued.
Patients are followed for a maximum of 8 years from randomization.
- Being tested
- irinotecan hydrochloride, oxaliplatin, leucovorin calcium, fluorouracil, cetuximab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Campto, Camptosar, CPT-11, irinotecan
Given IV
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
Also called CF, CFR, LV
Given IV
fluorouracilDrug
Also called 5-fluorouracil, 5-Fluracil, 5-FU
Given IV
cetuximabBiological
Also called C225, C225 monoclonal antibody, IMC-C225, MOAB C225
Given IV
Locally Directed TherapyDrug
Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (combination chemotherapy) | Experimental | Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. Receives: Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil |
| Arm B (combination chemotherapy) | Experimental | Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. Receives: Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: fluorouracil |
| Arm C (combination chemotherapy) | Experimental | Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease. Receives: Drug: irinotecan hydrochloride; Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil |
| Arm D (combination chemotherapy, monoclonal antibody) | Experimental | Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. Receives: Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil; Biological: cetuximab |
| Arm E (combination chemotherapy, monoclonal antibody) | Experimental | Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. Receives: Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: fluorouracil; Biological: cetuximab |
| Arm F (combination chemotherapy, monoclonal antibody) | Experimental | Patients received cetuximab as in arm D and chemotherapy as in arm C. Receives: Drug: irinotecan hydrochloride; Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil; Biological: cetuximab |
| Arm G (Locally directed therapy) | Other | Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists. Receives: Drug: Locally Directed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (Arms A and D: Wild-type KRAS Patients)
The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.
Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier.
Measured: At 3 years
Secondary outcomes (5)
Disease-free Survival (Arms A and D: Mutant KRAS Patients)
A secondary endpoint for this study was to investigate the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.
Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier.
Measured: At 3 years
Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients)
Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event free rates (percentage) are reported below for Wild-type KRAS Patients.
Measured: Up to 3 years
Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients)
Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event-free rates (percentage) are report below for mutant KRAS patients.
Measured: Up to 3 years
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients)
The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Measured: Assessed up to 8 years
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Mutant KRAS Patients)
The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Measured: Assessed up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2004 (estimated)
- Study startFeb 2004
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ColonStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 3,397 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eastern Cooperative Oncology Group
- Responsible party
- Sponsor
- Investigators
- Steven A Alberts, MD, Principal investigator, North Central Cancer Treatment Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079274
- Sponsor's protocol ID
- NCI-2009-00639
- Other IDs
- N0147, U10CA025224, CDR0000355132
- Status last verified
- May 2026
- First submitted
- 8 Mar 2004
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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 36306483Saberzadeh-Ardestani B, Foster NR, Lee HE, Shi Q, Alberts SR, Smyrk TC, Sinicrope FA. Association of tumor-infiltrating lymphocytes with survival depends on primary tumor sidedness in stage III colon cancers (NCCTG N0147) [Alliance]. Ann Oncol. 2022 Nov;33(11):1159-1167. doi: 10.1016/j.annonc.2022.07.1942. Epub 2022 Aug 10.
PubMed 35963480Azizi Z, Zheng C, Mosquera L, Pilote L, El Emam K; GOING-FWD Collaborators. Can synthetic data be a proxy for real clinical trial data? A validation study. BMJ Open. 2021 Apr 16;11(4):e043497. doi: 10.1136/bmjopen-2020-043497.
PubMed 33863713Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23.
PubMed 33356421Labadie JD, Hua X, Harrison TA, Banbury BL, Huyghe JR, Sun W, Shi Q, Yothers G, Alberts SR, Sinicrope FA, Goldberg RM, George TJ, Penney KL, Phipps AI, Cohen SA, Peters U, Chan AT, Newcomb PA. Genetic Predictors of Severe Skin Toxicity in Patients with Stage III Colon Cancer Treated with Cetuximab: NCCTG N0147 (Alliance). Cancer Epidemiol Biomarkers Prev. 2021 Feb;30(2):404-411. doi: 10.1158/1055-9965.EPI-20-1274. Epub 2020 Nov 17.
PubMed 33203692Lee H, Sha D, Foster NR, Shi Q, Alberts SR, Smyrk TC, Sinicrope FA. Analysis of tumor microenvironmental features to refine prognosis by T, N risk group in patients with stage III colon cancer (NCCTG N0147) (Alliance). Ann Oncol. 2020 Apr;31(4):487-494. doi: 10.1016/j.annonc.2020.01.011. Epub 2020 Jan 25.
PubMed 32165096Penney KL, Banbury BL, Bien S, Harrison TA, Hua X, Phipps AI, Sun W, Song M, Joshi AD, Alberts SR, Allegra CJ, Atkins J, Colangelo LH, George TJ, Goldberg RM, Lucas PC, Nair SG, Shi Q, Sinicrope FA, Wolmark N, Yothers G, Peters U, Newcomb PA, Chan AT. Genetic Variant Associated With Survival of Patients With Stage II-III Colon Cancer. Clin Gastroenterol Hepatol. 2020 Nov;18(12):2717-2723.e3. doi: 10.1016/j.cgh.2019.11.046. Epub 2019 Dec 4.
PubMed 31811950Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, Andre T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208.
PubMed 31268130Zaanan A, Shi Q, Taieb J, Alberts SR, Meyers JP, Smyrk TC, Julie C, Zawadi A, Tabernero J, Mini E, Goldberg RM, Folprecht G, Van Laethem JL, Le Malicot K, Sargent DJ, Laurent-Puig P, Sinicrope FA. Role of Deficient DNA Mismatch Repair Status in Patients With Stage III Colon Cancer Treated With FOLFOX Adjuvant Chemotherapy: A Pooled Analysis From 2 Randomized Clinical Trials. JAMA Oncol. 2018 Mar 1;4(3):379-383. doi: 10.1001/jamaoncol.2017.2899.
PubMed 28983557Sinicrope FA, Shi Q, Allegra CJ, Smyrk TC, Thibodeau SN, Goldberg RM, Meyers JP, Pogue-Geile KL, Yothers G, Sargent DJ, Alberts SR. Association of DNA Mismatch Repair and Mutations in BRAF and KRAS With Survival After Recurrence in Stage III Colon Cancers : A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Oncol. 2017 Apr 1;3(4):472-480. doi: 10.1001/jamaoncol.2016.5469.
PubMed 28006055Sticca RP, Alberts SR, Mahoney MR, Sargent DJ, Finstuen LM, Nelson GD, Husted TM, Franko J, Goldman CD, Pockaj BA. Current use and surgical efficacy of laparoscopic colectomy in colon cancer. J Am Coll Surg. 2013 Jul;217(1):56-62; discussion 62-3. doi: 10.1016/j.jamcollsurg.2013.02.023. Epub 2013 Apr 24.
PubMed 23623224Alberts SR, Sargent DJ, Nair S, Mahoney MR, Mooney M, Thibodeau SN, Smyrk TC, Sinicrope FA, Chan E, Gill S, Kahlenberg MS, Shields AF, Quesenberry JT, Webb TA, Farr GH Jr, Pockaj BA, Grothey A, Goldberg RM. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial. JAMA. 2012 Apr 4;307(13):1383-93. doi: 10.1001/jama.2012.385.
PubMed 22474202