Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer

Stage III Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079274
• Other study ID #: NCI-2009-00639
• Secondary ID: N0147U10CA025224
• Status: Completed
• Phase: Phase 3
• Start date: February 2004
• Est. completion date: November 2012

Study information

• Verified date: April 2020
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

PRIMARY OBJECTIVES:

I. Disease-free Survival (Arms A and D: Wild-type KRAS Patients)

SECONDARY OBJECTIVES:

I. 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.

Other known NCT identifiers

• NCT00170092

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3397
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Colon
• Colonic Neoplasms
• Stage III Colon Cancer

Intervention

Drug:
• irinotecan hydrochloride
Given IV
• oxaliplatin
Given IV
• leucovorin calcium
Given IV
• fluorouracil
Given IV

Biological:
• cetuximab
Given IV

Drug:
• Locally Directed Therapy
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.

Locations

Country	Name	City	State
Canada	The Royal Victoria Hospital	Barrie	Ontario
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cambridge Memorial Hospital	Cambridge	Ontario
Canada	PEI Cancer Treatment Centre-Queen Elizabeth Hospital	Charlottetown	Prince Edward Island
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	Grand River Regional Cancer Centre at Grand River Hospital	Kitchener	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	McGill University Department of Oncology	Montreal	Quebec
Canada	Lions Gate Hospital	North Vancouver	British Columbia
Canada	Ottawa Health Research Institute-General Division	Ottawa	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Atlantic Health Sciences Corporation-Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Algoma District Cancer Program Sault Area Hospital	Sault Ste Marie	Ontario
Canada	Niagara Health System-Saint Catharines General	St. Catharines	Ontario
Canada	Regional Cancer Program of The Hopital Regional de Sudbury Regional Hopital	Sudbury	Ontario
Canada	BCCA-Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Thunder Bay Regional Health Science Centre	Thunder Bay	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Saint Michael's Hospital	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Trillium Health Centre-West Toronto	Toronto	Ontario
Canada	University Health Network-Princess Margaret Hospital	Toronto	Ontario
Canada	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia
Canada	Windsor Regional Cancer Centre	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Puerto Rico	Andres Grillasca Hospital	Ponce
Puerto Rico	Hato Rey Hematology Oncology Group	San Juan
Puerto Rico	I Gonzales Martinez-Oncologic Hospital	San Juan
Puerto Rico	San Juan City Hospital	San Juan
Puerto Rico	San Juan Veterans Affairs Medical Center	San Juan
United States	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii
United States	Conklin Regional Cancer Center	Aberdeen	South Dakota
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Bixby Medical Center	Adrian	Michigan
United States	Hickman Cancer Center	Adrian	Michigan
United States	Akron City Hospital	Akron	Ohio
United States	Akron General Medical Center	Akron	Ohio
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Hematology Oncology Associates	Albuquerque	New Mexico
United States	New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico
United States	Presbyterian Kaseman Hospital	Albuquerque	New Mexico
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of New Mexico at Lovelace Medical Center	Albuquerque	New Mexico
United States	Harris, John Gilbert MD (UIA Investigator)	Alexandria	Minnesota
United States	Medini, Eitan MD (UIA Investigator)	Alexandria	Minnesota
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Saint Anthony's Health	Alton	Illinois
United States	The Don and Sybil Harrington Cancer Center	Amarillo	Texas
United States	McFarland Clinic	Ames	Iowa
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	AnMed Health Hospital	Anderson	South Carolina
United States	Michigan Cancer Research Consortium Community Clinical Oncology Program	Ann Arbor	Michigan
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Langlade Hospital and Cancer Center	Antigo	Wisconsin
United States	Memorial Hospital of Arkansas City	Arkansas City	Kansas
United States	Mission Hospitals Inc	Asheville	North Carolina
United States	Our Lady Bellefonte Hospital	Ashland	Kentucky
United States	Atlanta Regional CCOP	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Auburn Regional Medical Center	Auburn	Washington
United States	Augusta Oncology Associates PC	Augusta	Georgia
United States	Rush - Copley Medical Center	Aurora	Illinois
United States	The Medical Center of Aurora	Aurora	Colorado
United States	Well Star Cobb Hospital	Austell	Georgia
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Good Samaritan Hospital of Maryland	Baltimore	Maryland
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Johns Hopkins University	Baltimore	Maryland
United States	The Union Memorial Hospital	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Summa Barberton Hospital	Barberton	Ohio
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Ochsner Clinic Foundation-Baton Rouge	Baton Rouge	Louisiana
United States	Battle Creek Health System	Battle Creek	Michigan
United States	Bay Regional Medical Center	Bay City	Michigan
United States	Saint Francis Hospital and Health Centers	Beech Grove	Indiana
United States	Mary Rutan Hospital	Bellefontaine	Ohio
United States	Saint Joseph Hospital	Bellingham	Washington
United States	Merit Care Clinic Bemidji	Bemidji	Minnesota
United States	Southwestern Oncology Research Department	Bennington	Vermont
United States	Highlands Oncology Group-Bentonville	Bentonville	Arkansas
United States	Alta Bates Medical Center-Herrick Campus	Berkeley	California
United States	Saint Luke's Hospital	Bethlehem	Pennsylvania
United States	Constantinou, Costas L MD (UIA Investigator)	Bettendorf	Iowa
United States	Hematology Oncology Associates-Quad Cities	Bettendorf	Iowa
United States	Beverly Hospital	Beverly	Massachusetts
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Billings Clinic	Billings	Montana
United States	Deaconess Medical Center	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies PC	Billings	Montana
United States	Montana Cancer Consortium CCOP	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	Saint Vincent Healthcare	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Health Systems	Bismarck	North Dakota
United States	Mid Dakota Clinic	Bismarck	North Dakota
United States	Saint Alexius Medical Center	Bismarck	North Dakota
United States	Saint Joseph Medical Center	Bloomington	Illinois
United States	The Boardman Cancer Center	Boardman	Ohio
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Saint Luke's Mountain States Tumor Institute	Boise	Idaho
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Boulder Community Hospital	Boulder	Colorado
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Internal Medicine of Bozeman	Bozeman	Montana
United States	Brainerd Medical Center Inc	Brainerd	Minnesota
United States	Saint Joseph's Medical Center	Brainerd	Minnesota
United States	Harrison Bremerton Hematology and Oncology	Bremerton	Washington
United States	Ocean Medical Center	Brick	New Jersey
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Caritas Saint Elizabeth's Medical Center	Brighton	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	The North Division of Montefiore Medical Center	Bronx	New York
United States	Long Island College Hospital	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Veterans Affairs Western New York Health Care System-Buffalo	Buffalo	New York
United States	Providence Saint Joseph Medical Center	Burbank	California
United States	Mills - Peninsula Hospitals	Burlingame	California
United States	Alamance Regional Medical Center	Burlington	North Carolina
United States	University of Vermont	Burlington	Vermont
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana
United States	Cooper Hospital University Medical Center	Camden	New Jersey
United States	Aultman Health Foundation	Canton	Ohio
United States	Graham Hospital Association	Canton	Illinois
United States	Mercy Medical Center	Canton	Ohio
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Southeast Missouri Hospital	Cape Girardeau	Missouri
United States	Marion Community Hospital	Carbondale	Pennsylvania
United States	Saint Anthony Regional Hospital	Carroll	Iowa
United States	Memorial Hospital	Carthage	Illinois
United States	East Bay Radiation Oncology Center	Castro Valley	California
United States	Eden Hospital Medical Center	Castro Valley	California
United States	Valley Medical Oncology Consultants-Castro Valley	Castro Valley	California
United States	Cedar Rapids Oncology Association	Cedar Rapids	Iowa
United States	Iowa Blood and Cancer Care PLC	Cedar Rapids	Iowa
United States	Mercy Hospital	Cedar Rapids	Iowa
United States	Oncology Associates	Cedar Rapids	Iowa
United States	Saint Luke's Hospital	Cedar Rapids	Iowa
United States	Providence Centralia Hospital	Centralia	Washington
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Hematology and Oncology Associates	Chicago	Illinois
United States	Illinois Masonic Medical Center	Chicago	Illinois
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	Mount Sinai Hospital Medical Center	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Resurrection Healthcare	Chicago	Illinois
United States	Swedish Covenant Hospital	Chicago	Illinois
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	Weiss Memorial Hospital	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa
United States	Memorial Hospital Colorado Springs	Colorado Springs	Colorado
United States	Penrose-Saint Francis Healthcare	Colorado Springs	Colorado
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Columbus CCOP	Columbus	Ohio
United States	Doctors Hospital	Columbus	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	John B Amos Cancer Center	Columbus	Georgia
United States	Mount Carmel Health Center West	Columbus	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	New Hampshire Oncology-Hematology PA	Concord	New Hampshire
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Bay Area Hospital	Coos Bay	Oregon
United States	Alegent Health Mercy Hospital	Council Bluffs	Iowa
United States	Hematology and Oncology Associates of Rhode Island Inc	Cranston	Rhode Island
United States	Texas Health Presbyterian Hospital Dallas	Dallas	Texas
United States	Danbury Hospital	Danbury	Connecticut
United States	Danville Regional Medical Center	Danville	Virginia
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	Genesis Medical Center - East Campus	Davenport	Iowa
United States	Genesis Medical Center - West Campus	Davenport	Iowa
United States	Dayton CCOP	Dayton	Ohio
United States	Good Samaritan Hospital - Dayton	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Miami Valley Hospital	Dayton	Ohio
United States	Samaritan North Health Center	Dayton	Ohio
United States	Veteran Affairs Medical Center	Dayton	Ohio
United States	Halifax Medical Center-Centers for Oncology	Daytona Beach	Florida
United States	Oakwood Hospital	Dearborn	Michigan
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Dekalb Medical Center	Decatur	Georgia
United States	Veterans Administration Medical Center	Decatur	Georgia
United States	North Broward Medical Center	Deerfield Beach	Florida
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Colorado Cancer Research Program CCOP	Denver	Colorado
United States	Exempla Saint Joseph Hospital	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - Saint Lukes Medical Center - Health One	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	Saint Anthony Central Hospital	Denver	Colorado
United States	Columbia Parkland Medical Center	Derry	New Hampshire
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Iowa Oncology Research Association CCOP	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Mercy Capitol	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Saint John Hospital and Medical Center	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	Bayhealth Medical Center at Kent General	Dover	Delaware
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope	Duarte	California
United States	Finley Hospital	Dubuque	Iowa
United States	Duluth Clinic CCOP	Duluth	Minnesota
United States	Miller-Dwan Hospital	Duluth	Minnesota
United States	Saint Luke's Hospital of Duluth	Duluth	Minnesota
United States	Saint Mary's Medical Center	Duluth	Minnesota
United States	Michigan State University - Breslin Cancer Center	East Lansing	Michigan
United States	Veterans Adminstration New Jersey Health Care System	East Orange	New Jersey
United States	Pocono Medical Center	East Stroudsburg	Pennsylvania
United States	Hematology Oncology Associates of Central New York	East Syracuse	New York
United States	Easton Hospital	Easton	Pennsylvania
United States	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin
United States	Mayo Clinic Health System Eau Claire Hospital - Luther Campus	Eau Claire	Wisconsin
United States	Midelfort Clinic-Clairemont Campus	Eau Claire	Wisconsin
United States	Sacred Heart Hospital	Eau Claire	Wisconsin
United States	Fairview-Southdale Hospital	Edina	Minnesota
United States	Saint Anthony Memorial Hospital	Effingham	Illinois
United States	Cancer Center of Kansas - El Dorado	El Dorado	Kansas
United States	The Center for Integrative Cancer Medicine	El Paso	Texas
United States	Sherman Hospital	Elgin	Illinois
United States	Cancer Institute at Alexian Brothers	Elk Grove Village	Illinois
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Hematology Oncology Center Incorporated	Elyria	Ohio
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Swedish Medical Center	Englewood	Colorado
United States	Ephrata Cancer Center	Ephrata	Pennsylvania
United States	Green Bay Oncology - Escanaba	Escanaba	Michigan
United States	Eureka Hospital	Eureka	Illinois
United States	Evanston CCOP-NorthShore University HealthSystem	Evanston	Illinois
United States	Saint Francis Hospital	Evanston	Illinois
United States	Exeter Hospital	Exeter	New Hampshire
United States	Northbay Cancer Center	Fairfield	California
United States	Innovis Health South University	Fargo	North Dakota
United States	Meritcare Hospital	Fargo	North Dakota
United States	MeritCare Medical Group	Fargo	North Dakota
United States	Veterans Administration Medical Center	Fargo	North Dakota
United States	Saint Francis Hospital	Federal Way	Washington
United States	Etzell, Paul S MD (UIA Investigator)	Fergus Falls	Minnesota
United States	Swenson, Wade II, MD (UIA Investigator)	Fergus Falls	Minnesota
United States	Blanchard Valley Hospital	Findlay	Ohio
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Genesys Regional Medical Center	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Regional Medical Center	Flint	Michigan
United States	Central Wisconsin Cancer Program	Fond Du Lac	Wisconsin
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Saint Edward Mercy Medical Center	Fort Smith	Arkansas
United States	Fort Wayne Medical Oncology and Hematology Inc - State Boulevard	Fort Wayne	Indiana
United States	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	Fredericksburg Oncology Inc	Fredericksburg	Virginia
United States	CentraState Medical Center	Freehold	New Jersey
United States	Fremont Area Medical Center	Fremont	Nebraska
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Kaiser Permanente, Fremont	Fremont	California
United States	Valley Medical Oncology Consultants-Fremont	Fremont	California
United States	California Cancer Center - North Fresno	Fresno	California
United States	Cancer Care Associates	Fresno	California
United States	Unity Hospital	Fridley	Minnesota
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	University of Florida	Gainesville	Florida
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	Intercommunity Cancer Center	Galesburg	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	Gaston Memorial Hospital	Gastonia	North Carolina
United States	Banner Thunderbird Medical Center	Glendale	Arizona
United States	Adirondack Cancer Center	Glens Falls	New York
United States	Addison Gilbert Hospital	Gloucester	Massachusetts
United States	Riverside Middle Peninsula Cancer Center	Gloucester	Virginia
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Wayne Memorial Hospital	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	Altru Cancer Center	Grand Forks	North Dakota
United States	Saint Francis Medical Center	Grand Island	Nebraska
United States	Saint Mary's Hospital and Regional Medical Center	Grand Junction	Colorado
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	Saint Mary's Health Care	Grand Rapids	Michigan
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Spectrum Health-Blodgett Campus	Grand Rapids	Michigan
United States	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana
United States	Berdeaux, Donald MD (UIA Investigator)	Great Falls	Montana
United States	Big Sky Oncology	Great Falls	Montana
United States	Great Falls Clinic	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Green Bay Oncology at Saint Vincent Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology Limited at Saint Mary's Hospital	Green Bay	Wisconsin
United States	Saint Mary's Hospital	Green Bay	Wisconsin
United States	Saint Vincent Hospital	Green Bay	Wisconsin
United States	California Cancer Care - Greenbrae	Greenbrae	California
United States	Sutter Health Western Division Cancer Research Group	Greenbrae	California
United States	Franklin Medical Center	Greenfield	Massachusetts
United States	Greenville CCOP	Greenville	South Carolina
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Wayne Hospital	Greenville	Ohio
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Washington County Hospital	Hagerstown	Maryland
United States	Cancer Institute of New Jersey At Hamilton	Hamilton	New Jersey
United States	Catskill Regional Medical Center	Harris	New York
United States	PinnacleHealth Regional Cancer Center at Polyclinic Hospital	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Mason District Hospital	Havana	Illinois
United States	Kaiser Permanente, Hayward	Hayward	California
United States	Saint Rose Hospital	Hayward	California
United States	Geisinger South Wilkes Barre-Hazelton Cancer Center	Hazleton	Pennsylvania
United States	Saint Peter's Community Hospital	Helena	Montana
United States	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Holland Community Hospital	Holland	Michigan
United States	Holyoke Medical Center	Holyoke	Massachusetts
United States	Hawaii Medical Center East	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Oncare Hawaii Inc-Kuakini	Honolulu	Hawaii
United States	Oncare Hawaii Inc-POB II	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	University of Hawaii	Honolulu	Hawaii
United States	New Hampshire Oncology Hematology Associates	Hooksett	New Hampshire
United States	Hopedale Medical Complex - Hospital	Hopedale	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Ben Taub General Hospital	Houston	Texas
United States	Methodist Hospital	Houston	Texas
United States	Saint Luke's Episcopal Hospital	Houston	Texas
United States	Veterans Administration Medical Center	Houston	Texas
United States	Edwards Comprehensive Cancer Center	Huntington	West Virginia
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Cleveland Clinic Cancer Center Independence	Independence	Ohio
United States	Independence Regional Health Center	Independence	Missouri
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Richard L. Roudebush Veterans Affairs Medical Center	Indianapolis	Indiana
United States	Saint Vincent Hospital and Health Services	Indianapolis	Indiana
United States	Wishard Hospital	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Green Bay Oncology - Iron Mountain	Iron Mountain	Michigan
United States	Allegiance Health	Jackson	Michigan
United States	Veterans Affairs Medical Center	Jackson	Mississippi
United States	Edna Williams Cancer Center at the Baptist Cancer Institute	Jacksonville	Florida
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mercy Health System	Janesville	Wisconsin
United States	UW Cancer Center Johnson Creek	Johnson Creek	Wisconsin
United States	Joliet Oncology-Hematology Associates Limited	Joliet	Illinois
United States	Midwest Center for Hematology Oncology	Joliet	Illinois
United States	Freeman Health System	Joplin	Missouri
United States	Saint John's Regional Medical Center	Joplin	Missouri
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Kalamazoo Center for Medical Studies	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Glacier Oncology PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Provena Saint Mary's Hospital	Kankakee	Illinois
United States	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri
United States	Liberty Radiation Oncology Clinic	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Providence Medical Center	Kansas City	Kansas
United States	Radiation Oncology Practice Corporation - North	Kansas City	Missouri
United States	Radiation Oncology Practice Corporation South	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Joseph Health Center	Kansas City	Missouri
United States	Saint Luke's Cancer Institute	Kansas City	Missouri
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Truman Medical Center	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Good Samaritan Hospital	Kearney	Nebraska
United States	Cheshire Medical Center-Dartmouth-Hitchcock Keene	Keene	New Hampshire
United States	Keesler Medical Center	Keesler Air Force Base	Mississippi
United States	Columbia Basin Hematology and Oncology PLLC	Kennewick	Washington
United States	Associates in Oncology Hematology PC -Kensington	Kensington	Maryland
United States	Cole, Sharon, K. M.D. (UIA Investigator)	Kenton	Ohio
United States	Kettering Medical Center	Kettering	Ohio
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas-Kingman	Kingman	Kansas
United States	Wellmont Holston Valley Hospital and Medical Center	Kingsport	Tennessee
United States	Kinston Medical Specialists PA	Kinston	North Carolina
United States	Evergreen Hospital Medical Center	Kirkland	Washington
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Howard Regional Healthcare System	Kokomo	Indiana
United States	Franciscan Skemp Healthcare	La Crosse	Wisconsin
United States	La Grange Memorial Hospital	La Grange	Illinois
United States	Laporte Hospital	La Porte	Indiana
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	LRGHealthcare-Lakes Region General Hospital	Laconia	New Hampshire
United States	Clarian Arnett Cancer Care	Lafayette	Indiana
United States	Deerpath Medical Associates	Lake Forest	Illinois
United States	The Watson Clinic	Lakeland	Florida
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Ingham Regional Medical Center	Lansing	Michigan
United States	Sparrow Hospital	Lansing	Michigan
United States	Lapeer Regional Hospital	Lapeer	Michigan
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	Memorial Medical Center - Las Cruces	Las Cruces	New Mexico
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Nevada Cancer Research Foundation CCOP	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Cancer Centers of Southwest Oklahoma Research - Lawton	Lawton	Oklahoma
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cancer Centers of Central Florida PA	Leesburg	Florida
United States	Central PA Hematology-Medical Oncology Associates PC	Lemoyne	Pennsylvania
United States	Beebe Medical Center	Lewes	Delaware
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Liberty Hospital	Liberty	Missouri
United States	North Shore Hematology Oncology	Libertyville	Illinois
United States	Lima Memorial Hospital	Lima	Ohio
United States	Saint Rita's Medical Center	Lima	Ohio
United States	Bryan LGH Medical Center East	Lincoln	Nebraska
United States	Bryan LGH Medical Center West	Lincoln	Nebraska
United States	Lincoln Medical Education Foundation Cancer Resource Center	Lincoln	Nebraska
United States	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska
United States	Meeker County Memorial Hospital	Litchfield	Minnesota
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Veteran's Administration Medical Center	Little Rock	Arkansas
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Saint Mary Mercy Hospital	Livonia	Michigan
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Longmont United Hospital	Longmont	Colorado
United States	University of Southern California	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Lynchburg Hematology-Oncology Clinic	Lynchburg	Virginia
United States	Mcdonough District Hospital	Macomb	Illinois
United States	Dean Hematology and Oncology Clinic	Madison	Wisconsin
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	UW Health Oncology - 1 South Park	Madison	Wisconsin
United States	Merle Mahr Cancer Center	Madisonville	Kentucky
United States	Elliot Hospital	Manchester	New Hampshire
United States	Manchester Memorial Hospital	Manchester	Connecticut
United States	Immanuel-Saint Joseph Hospital-Mayo Health System	Mankato	Minnesota
United States	DeSoto Regional Health System	Mansfield	Louisiana
United States	Mansfield General Hospital-MedCentral Health System	Mansfield	Ohio
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Marietta Memorial Hospital	Marietta	Ohio
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Bay Area Medical Center	Marinette	Wisconsin
United States	Vince Lombardi Cancer Clinic-Marinette	Marinette	Wisconsin
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Saint Joseph's Hospital	Marshfield	Wisconsin
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Fremont - Rideout Cancer Center	Marysville	California
United States	Mercy Medical Center - North Iowa	Mason City	Iowa
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	Saint Luke's Hospital	Maumee	Ohio
United States	Toledo Radiation Oncology at Northwest Ohio Onocolgy Center	Maumee	Ohio
United States	Loyola University Medical Center	Maywood	Illinois
United States	Cancer Center of Kansas - McPherson	McPherson	Kansas
United States	Lawrence Memorial	Medford	Massachusetts
United States	Riddle Hospital	Media	Pennsylvania
United States	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee
United States	Premier Oncology Hematology Associates	Merrillville	Indiana
United States	Banner Baywood Medical Center	Mesa	Arizona
United States	Banner Desert Medical Center	Mesa	Arizona
United States	Metairie Oncologists	Metairie	Louisiana
United States	Holy Family Hospital	Methuen	Massachusetts
United States	Baptist Hospital of Miami	Miami	Florida
United States	Saint Anthony Memorial Health Center	Michigan City	Indiana
United States	Middlesex Hospital	Middletown	Connecticut
United States	Orange Regional Medical Center	Middletown	New York
United States	Mid-Michigan Medical Center - Midland	Midland	Michigan
United States	Eastern Montana Cancer Center	Miles City	Montana
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Winthrop University Hospital	Mineola	New York
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Minneapolis Veterans Medical Center	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
United States	Trinity Cancer Care Center	Minot	North Dakota
United States	Community Medical Hospital	Missoula	Montana
United States	Montana Cancer Specialists	Missoula	Montana
United States	Saint Patrick Hospital - Community Hospital	Missoula	Montana
United States	Community Memorial Hospital	Missouri Valley	Iowa
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Providence Hospital	Mobile	Alabama
United States	Memorial Medical Center	Modesto	California
United States	Garneau, Stewart C MD (UIA Investigator)	Moline	Illinois
United States	Porubcin, Michael MD (UIA Investigator)	Moline	Illinois
United States	Sharis, Christine M MD (UIA Investigator)	Moline	Illinois
United States	Stoffel, Thomas J MD (UIA Investigator)	Moline	Illinois
United States	Trinity Medical Center	Moline	Illinois
United States	Vigliotti, Antonio, P.G. M.D. (UIA Investigator)	Moline	Illinois
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Louisiana State University Sciences Center- Monroe	Monroe	Louisiana
United States	Mercy Memorial Hospital	Monroe	Michigan
United States	Mountainside Hospital	Montclair	New Jersey
United States	Community Hospital of Monterey Peninsula	Monterey	California
United States	Chippewa County - Montevideo Hospital	Montevideo	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County	Mount Holly	New Jersey
United States	Good Samaritan Regional Medical Center	Mount Vernon	Illinois
United States	El Camino Hospital	Mountain View	California
United States	Palo Alto Medical Foundation-Camino Division	Mountain View	California
United States	Ball Memorial Hospital	Muncie	Indiana
United States	The Community Hospital	Munster	Indiana
United States	Mercy Health Partners-Hackley Campus	Muskegon	Michigan
United States	Mercy Health Partners-Mercy Campus	Muskegon	Michigan
United States	Edward Hospital	Naperville	Illinois
United States	Hematology Oncology Consultants Limited	Naperville	Illinois
United States	Meharry Medical College	Nashville	Tennessee
United States	Tennessee Oncology PLLC- Centennial Medical Center	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Metrowest Medical Center Incorporated	Natick	Massachusetts
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Louisiana State University Health Science Center	New Orleans	Louisiana
United States	Medical Center of Louisiana	New Orleans	Louisiana
United States	Ochsner Clinic CCOP	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Saint Luke's Roosevelt Hospital Center - Saint Luke's Division	New York	New York
United States	Licking Memorial Hospital	Newark	Ohio
United States	Peninsula Cancer Institute-Newport News	Newport News	Virginia
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	Cancer Care and Hematology Specialists of Chicagoland PC	Niles	Illinois
United States	Bromenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center Foundation	Normal	Illinois
United States	Great Plains Regional Medical Center	North Platte	Nebraska
United States	Southwest VA Regional Cancer Center	Norton	Virginia
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	Norwood Hospital	Norwood	Massachusetts
United States	Nyack Hospital	Nyack	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	Bay Area Breast Surgeons Inc	Oakland	California
United States	Bay Area Tumor Institution CCOP	Oakland	California
United States	Highland General Hospital	Oakland	California
United States	Kaiser Permanente-Oakland	Oakland	California
United States	Larry G Strieff MD Medical Corporation	Oakland	California
United States	Tom K Lee Inc	Oakland	California
United States	Oconomowoc Memorial Hospital-ProHealth Care Inc	Oconomowoc	Wisconsin
United States	Green Bay Oncology - Oconto Falls	Oconto Falls	Wisconsin
United States	Cancer Care Associates	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Olathe Medical Center	Olathe	Kansas
United States	Capital Medical Center	Olympia	Washington
United States	Providence - Saint Peter Hospital	Olympia	Washington
United States	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska
United States	Alegent Health Immanuel Medical Center	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	Missouri Valley Cancer Consortium CCOP	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Burgess Memorial Hospital	Onawa	Iowa
United States	Saint Joseph Hospital	Orange	California
United States	Integrated Community Oncology Network - Orange Park Cancer Center	Orange Park	Florida
United States	Bayview Oncology Associates	Oregon	Ohio
United States	Saint Charles Hospital	Oregon	Ohio
United States	Florida Hospital	Orlando	Florida
United States	M D Anderson Cancer Center- Orlando	Orlando	Florida
United States	Cancer Center of Kansas - Ottawa	Ottawa	Kansas
United States	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois
United States	Ottawa Regional Hospital and Healthcare Center	Ottawa	Illinois
United States	Menorah Medical Center	Overland Park	Kansas
United States	Radiation Oncology Practice Corporation Southwest	Overland Park	Kansas
United States	Desert Regional Medical Center	Palm Springs	California
United States	Palo Alto Medical Foundation Heath Care	Palo Alto	California
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Midlands Community Hospital	Papillion	Nebraska
United States	Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Cancer Center of Kansas - Parsons	Parsons	Kansas
United States	Singing River Hospital	Pascagoula	Mississippi
United States	North Shore Medical Center Cancer Center	Peabody	Massachusetts
United States	Pekin Cancer Treatment Center	Pekin	Illinois
United States	Pekin Hospital	Pekin	Illinois
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Sacred Heart Medical Oncology Group - Davis Highway	Pensacola	Florida
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Illinois Oncology Research Association CCOP	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Hospital	Peru	Illinois
United States	Northern Michigan Regional Hospital	Petoskey	Michigan
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Aria Health-Torresdale Campus	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Warren Hospital	Phillipsburg	New Jersey
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Phoenix Indian Medical Center	Phoenix	Arizona
United States	Western Regional CCOP	Phoenix	Arizona
United States	Mount Carmel Regional Cancer Center	Pittsburg	Kansas
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Berkshire Hematology Oncology PC	Pittsfield	Massachusetts
United States	Valley Care Health System - Pleasanton	Pleasanton	California
United States	Valley Medical Oncology Consultants	Pleasanton	California
United States	Saint Joseph Mercy Oakland	Pontiac	Michigan
United States	Olympic Medical Center	Port Angeles	Washington
United States	Saint Joseph Mercy Port Huron	Port Huron	Michigan
United States	Adventist Medical Center	Portland	Oregon
United States	Columbia River Oncology Program	Portland	Oregon
United States	Kaiser Permanente	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center	Portland	Oregon
United States	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon
United States	Northwest Cancer Specialists-Rose Quarter Cancer Center	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Providence Saint Vincent Medical Center	Portland	Oregon
United States	Portsmouth Regional Hospital	Portsmouth	New Hampshire
United States	Pottstown Memorial Medical Center	Pottstown	Pennsylvania
United States	Cancer Center of Kansas - Pratt	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Princeton Community Hospital	Princeton	West Virginia
United States	Miriam Hospital	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Saint Mary Corwin Medical Center	Pueblo	Colorado
United States	Good Samaritan Community Hospital	Puyallup	Washington
United States	Commonwealth Hematology Oncology PC-Quincy	Quincy	Massachusetts
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Saint Joseph Medical Center	Reading	Pennsylvania
United States	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey
United States	Shasta Regional Medical Center	Redding	California
United States	Kaiser Permanente-Redwood City	Redwood City	California
United States	Valley Medical Center	Renton	Washington
United States	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin
United States	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin
United States	Kaiser Permanente-Richmond	Richmond	California
United States	Reid Hospital and Health Care Services	Richmond	Indiana
United States	West Suburban Cancer Center	River Forest	Illinois
United States	Southern Regional Medical Center	Riverdale	Georgia
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	Highland Hospital	Rochester	New York
United States	Interlakes Foundation Inc-Rochester	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Swedish American Hospital	Rockford	Illinois
United States	Associates In Oncology Hematology PC-Rockville	Rockville	Maryland
United States	Kaiser Permanente-Roseville	Roseville	California
United States	Sutter Roseville Medical Center	Roseville	California
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sarah Culbertson Memorial Hospital	Rushville	Illinois
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Kaiser Permanente - Sacramento	Sacramento	California
United States	Kaiser Permanente-South Sacramento	Sacramento	California
United States	Sutter General Hospital	Sacramento	California
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	Saint Mary's of Michigan	Saginaw	Michigan
United States	Montgomery and Associates MD PA	Saint Augustine	Florida
United States	Missouri Cancer Care PC - Saint Charles	Saint Charles	Missouri
United States	CentraCare Clinic	Saint Cloud	Minnesota
United States	Saint Cloud Hospital	Saint Cloud	Minnesota
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Lakeland Hospital	Saint Joseph	Michigan
United States	Center for Cancer Care and Research	Saint Louis	Missouri
United States	Christian Hospital Northeast - Northwest	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Saint Anthony's Medical Center	Saint Louis	Missouri
United States	Saint John's Mercy Medical Center	Saint Louis	Missouri
United States	Saint Louis Cancer and Breast Institute	Saint Louis	Missouri
United States	Saint Louis University Hospital	Saint Louis	Missouri
United States	Saint Louis-Cape Girardeau CCOP	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Metro-Minnesota CCOP	Saint Louis Park	Minnesota
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	Saint Joseph's Hospital - Healtheast	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Cancer Care Center, Incorporated	Salem	Ohio
United States	Salem Hospital	Salem	Oregon
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	Audie L Murphy Veterans Affairs Hospital	San Antonio	Texas
United States	Cancer Therapy and Research Center at The UT Health Science Center at San Antonio	San Antonio	Texas
United States	South Texas Oncology and Hematology PA	San Antonio	Texas
United States	University Hospital	San Antonio	Texas
United States	University of Texas Health Science Center	San Antonio	Texas
United States	Kaiser Permanente	San Diego	California
United States	Naval Medical Center -San Diego	San Diego	California
United States	University of California San Diego - Veterans Administration	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	Kaiser Permanente-San Francisco	San Francisco	California
United States	University of California San Francisco Medical Center-Mount Zion	San Francisco	California
United States	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California
United States	Doctors Medical Center- JC Robinson Regional Cancer Center	San Pablo	California
United States	Kaiser Permanente-San Rafael	San Rafael	California
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care	Sandusky	Ohio
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Kaiser Permanente-Santa Rosa	Santa Rosa	California
United States	Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Florida Cancer Specialists - Sarasota Downtown	Sarasota	Florida
United States	Adult and Pediatric Urology PLLP	Sartell	Minnesota
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Saint Joseph's-Candler Health System	Savannah	Georgia
United States	Guthrie Clinic - Sayre	Sayre	Pennsylvania
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Community Medical Center	Scranton	Pennsylvania
United States	Hematology and Oncology Associates of North East Pennsylvania	Scranton	Pennsylvania
United States	Mercy Hospital	Scranton	Pennsylvania
United States	Moses Taylor Hospital	Scranton	Pennsylvania
United States	Scranton Hematology Oncology	Scranton	Pennsylvania
United States	Group Health Cooperative	Seattle	Washington
United States	Minor and James Medical PLLC	Seattle	Washington
United States	Puget Sound Oncology Consortium	Seattle	Washington
United States	Swedish Medical Center-First Hill	Seattle	Washington
United States	The Polyclinic	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Virginia Mason CCOP	Seattle	Washington
United States	Grand View Hospital	Sellersville	Pennsylvania
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	Shawnee Mission Medical Center	Shawnee Mission	Kansas
United States	Welch Cancer Center	Sheridan	Wyoming
United States	Highland Clinic	Shreveport	Louisiana
United States	Louisiana State University	Shreveport	Louisiana
United States	Mercy Medical Center-Sioux City	Sioux City	Iowa
United States	Saint Luke's Regional Medical Center	Sioux City	Iowa
United States	Siouxland Hematology - Oncology Associates	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota
United States	Medical X-Ray Center	Sioux Falls	South Dakota
United States	Sanford Cancer Center-Oncology Clinic	Sioux Falls	South Dakota
United States	Sanford University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	Edward H Kaplan MD and Associates	Skokie	Illinois
United States	Hematology Oncology Associates of Illinois - Skokie	Skokie	Illinois
United States	Midwest Cancer Research Group Incorporated	Skokie	Illinois
United States	Somerset Medical Center	Somerville	New Jersey
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	Saint Joseph's Medical Center	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	Kaiser Permanente-South San Francisco	South San Francisco	California
United States	South Shore Hospital	South Weymouth	Massachusetts
United States	Providence Hospital	Southfield	Michigan
United States	Sparta Cancer Treatment Center	Sparta	New Jersey
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Upstate Carolina CCOP	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Holy Family Hospital	Spokane	Washington
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Saint Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Community Hospital Springfield	Springfield	Ohio
United States	Cox Medical Center	Springfield	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield	Springfield	Missouri
United States	Saint John's Hospital	Springfield	Missouri
United States	Stamford Hospital	Stamford	Connecticut
United States	Geisinger Medical Group	State College	Pennsylvania
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	Saint Michael's Hospital	Stevens Point	Wisconsin
United States	Kaiser Permanente-Stockton	Stockton	California
United States	Martin Memorial Cancer Center	Stuart	Florida
United States	Martin Memorial Hospital - South	Stuart	Florida
United States	Martin Memorial Medical Center - North	Stuart	Florida
United States	Green Bay Oncology - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Overlook Hospital	Summit	New Jersey
United States	Flower Memorial Hospital	Sylvania	Ohio
United States	State University of New York Upstate Medical University	Syracuse	New York
United States	Allenmore Hospital	Tacoma	Washington
United States	Multicare Health System	Tacoma	Washington
United States	Northwest CCOP	Tacoma	Washington
United States	Saint Clare Hospital	Tacoma	Washington
United States	Saint Joseph Medical Center	Tacoma	Washington
United States	Tacoma General Hospital	Tacoma	Washington
United States	Morton Hospital and Medical Center	Taunton	Massachusetts
United States	Scott and White Memorial Hospital	Temple	Texas
United States	North Suburban Medical Center	Thornton	Colorado
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	Mercy Cancer Center at Saint Anne Mercy Hospital	Toledo	Ohio
United States	Saint Vincent Mercy Medical Center	Toledo	Ohio
United States	The Toledo Hospital	Toledo	Ohio
United States	Toledo Clinic	Toledo	Ohio
United States	Toledo Community Hospital Oncology Program CCOP	Toledo	Ohio
United States	University of Toledo	Toledo	Ohio
United States	Saint Francis Hospital and Medical Center - Topeka	Topeka	Kansas
United States	Stormont-Vail Regional Health Center	Topeka	Kansas
United States	Munson Medical Center	Traverse City	Michigan
United States	Upper Valley Medical Center	Troy	Ohio
United States	Tahoe Forest Cancer Center	Truckee	California
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Natalie W Bryant Cancer Center	Tulsa	Oklahoma
United States	Associates In Hematology Oncology PC-Upland	Upland	Pennsylvania
United States	Carle Clinic-Urbana Main	Urbana	Illinois
United States	Carle Foundation dba Carle Cancer Center	Urbana	Illinois
United States	Faxton-Saint Luke's Healthcare	Utica	New York
United States	South Georgia Medical Center	Valdosta	Georgia
United States	Kaiser Permanente-Vallejo	Vallejo	California
United States	Sutter Solano Medical Center	Vallejo	California
United States	Southwest Washington Medical Center	Vancouver	Washington
United States	South Jersey Healthcare	Vineland	New Jersey
United States	Virtua West Jersey Hospital Voorhees	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Maui Memorial Medical Center	Wailuku	Hawaii
United States	Pacific Cancer Institute of Maui	Wailuku	Hawaii
United States	Kaiser Permanente-Walnut Creek	Walnut Creek	California
United States	Saint John Macomb-Oakland Hospital	Warren	Michigan
United States	Saint Joseph Cancer Center	Warren	Ohio
United States	Kent County Hospital	Warwick	Rhode Island
United States	Howard University Hospital	Washington	District of Columbia
United States	Lombardi Comprehensive Cancer Center at Georgetown University	Washington	District of Columbia
United States	Marion L Shepard Cancer Center	Washington	North Carolina
United States	Washington Hospital Center	Washington	District of Columbia
United States	Covenant Medical Center	Waterloo	Iowa
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	Marshfield Clinic-Wausau Center	Wausau	Wisconsin
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Jennersville Regional Hospital	West Grove	Pennsylvania
United States	Palm Beach Cancer Institute-Main Office	West Palm Beach	Florida
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	Saint Ann's Hospital	Westerville	Ohio
United States	Noble Hospital	Westfield	Massachusetts
United States	Diagnostic and Treatment Center	Weston	Wisconsin
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Wheeling Hospital	Wheeling	West Virginia
United States	Dickstein Cancer Treatment Center	White Plains	New York
United States	Associates In Womens Health	Wichita	Kansas
United States	Cancer Center of Kansas - Main Office	Wichita	Kansas
United States	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas
United States	Via Christi Regional Medical Center	Wichita	Kansas
United States	Wichita CCOP	Wichita	Kansas
United States	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania
United States	Peninsula Cancer Institute	Williamsburg	Virginia
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Clinton Memorial Hospital	Wilmington	Ohio
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Wilson Medical Center	Wilson	North Carolina
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas
United States	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	Minnesota Oncology and Hematology PA-Woodbury	Woodbury	Minnesota
United States	Woodwinds Health Campus	Woodbury	Minnesota
United States	Cancer Treatment Center	Wooster	Ohio
United States	Cleveland Clinic Wooster Specialty Center	Wooster	Ohio
United States	Wright-Patterson Medical Center	Wright-Patterson Air Force Base	Ohio
United States	Lankenau Hospital	Wynnewood	Pennsylvania
United States	Mainline Health CCOP	Wynnewood	Pennsylvania
United States	Metro Health Hospital	Wyoming	Michigan
United States	Greene Memorial Hospital	Xenia	Ohio
United States	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington
United States	Saint Elizabeth Hospital Medical Center	Youngstown	Ohio
United States	Genesis HealthCare System	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Eastern Cooperative Oncology Group

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 3 years
Secondary	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.	At 3 years
Secondary	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.	Up to 3 years
Secondary	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.	Up to 3 years
Secondary	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.	Assessed up to 8 years
Secondary	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.	Assessed up to 8 years

External Links

•   Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.