Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003594
• Other study ID #: NCCTG-N9741
• Secondary ID: CDR0000066665CAN
• Status: Completed
• Phase: Phase 3
• Start date: October 1998
• Est. completion date: October 2004

Study information

• Verified date: April 2020
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Description:

OBJECTIVES:

• Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan.

• Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens.

• Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms.

Only arm II remains open to accrual.

• Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.)

• Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks.

• Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1691
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy

• Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:

• More than 5 years has elapsed since primary surgery OR

• Primary cancer was stage I or II

• Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel

• Measurable or evaluable disease

• No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• AST no greater than 5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled hypertension

• No unstable angina

• No symptomatic congestive heart failure

• No myocardial infarction within the past 6 months

• No serious uncontrolled arrhythmia

• No New York Heart Association class III or IV cardiac disease

Pulmonary:

• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

• No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active or uncontrolled infection

• No symptomatic sensory peripheral neuropathy

• No known allergy to platinum compounds

• No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician

• No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis

• No medical or psychiatric conditions that would preclude study

• No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day

• Colostomy or ileostomy allowed at investigator's discretion

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease

• No concurrent sargramostim (GM-CSF)

Chemotherapy:

• No prior chemotherapy for advanced colorectal cancer

• No prior standard adjuvant chemotherapy for rectal cancer

• Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)

• No prior radiotherapy to more than 15% of bone marrow

• No prior standard adjuvant radiotherapy for rectal cancer

Surgery:

• See Disease Characteristics

• At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered

• Insertion of a vascular access device not considered major or minor surgery

Other:

• No other concurrent investigational agents

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• irinotecan

• fluorouracil

• leucovorin calcium

• oxaliplatin

Locations

Country	Name	City	State
Canada	William Osler Health Centre	Brampton	Ontario
Canada	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	CHUM Hopital Saint-Luc	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Nanaimo Cancer Clinic	Nanaimo	British Columbia
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Lions Gate Hospital	North Vancouver
Canada	Peterborough Oncology Clinic	Peterborough	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Pasqua Hospital	Regina	Saskatchewan
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Algoma District Medical Group	Sault Sainte Marie	Ontario
Canada	Hotel Dieu Health Sciences Hospital - Niagara	St. Catharines	Ontario
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Saint Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Victoria	British Columbia
Canada	Humber River Regional Hospital	Weston	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Puerto Rico	Centro Mamografia Hospital Oncologico	Hato Rey
Puerto Rico	San Juan City Hospital	San Juan
Puerto Rico	Veterans Affairs Medical Center - San Juan	San Juan
South Africa	Medical Oncology Centre of Rosebank	Johannesburg
South Africa	Pretoria Academic Hospitals	Pretoria
United States	Bixby Medical Center	Adrian	Michigan
United States	Akron City Hospital	Akron	Ohio
United States	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico
United States	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico
United States	Alexandria Clinic	Alexandria	Minnesota
United States	Alexandria Radiation Oncology	Alexandria	Minnesota
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	William R. Bliss Cancer Center	Ames	Iowa
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Fox Valley Hematology and Oncology	Appleton	Wisconsin
United States	Cancer Center of Kansas - Arkansas City	Arkansas City	Kansas
United States	Memorial Medical Center	Ashland	Wisconsin
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Columbia Medical Center of Aurora North Campus	Aurora	Colorado
United States	Muhlenberg Hospital Center	Bethlehem	Pennsylvania
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi
United States	Veterans Affairs Medical Center - Birmingham	Birmingham	Alabama
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Health System	Bismarck	North Dakota
United States	Mid Dakota Clinic, P.C.	Bismarck	North Dakota
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	BroMenn Lifecare Center	Bloomington	Illinois
United States	St. Joseph's Hospital Medical Center	Bloomington	Illinois
United States	Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Brainerd Medical Center	Brainerd	Minnesota
United States	St. Joseph's Medical Center	Brainerd	Minnesota
United States	Bristol Hospital	Bristol	Connecticut
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Aultman Cancer Center	Canton	Ohio
United States	Graham Hospital Association	Canton	Illinois
United States	Mercy Ireland Cancer Center	Canton	Ohio
United States	Marion Community Hospital	Carbondale	Pennsylvania
United States	Saint Anthony Regional Hospital	Carroll	Iowa
United States	Memorial Hospital	Carthage	Illinois
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Center for Cancer And Hematologic Disease	Cherry Hill	New Jersey
United States	Hematology Oncology Associates of Illinois - Lake Shore Dr	Chicago	Illinois
United States	Hematology-Oncology Associates of Illinois	Chicago	Illinois
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois
United States	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Alegent Health Southwest Iowa Medical Center	Council Bluffs	Iowa
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado
United States	HealthOne Rose Medical Center	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian-St Luke's Medical Center	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Veterans Affairs Medical Center - Denver	Denver	Colorado
United States	Des Moines General Hospital	Des Moines	Iowa
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates	Des Moines	Iowa
United States	Mercy Hospital Medical Center	Des Moines	Iowa
United States	Holy Family Medical Center	Des Plaines	Illinois
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Veterans Affairs Medical Center - Detroit	Detroit	Michigan
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	Radiation Oncology Center	Dodge City	Kansas
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California
United States	DuBois Regional Medical Center	DuBois	Pennsylvania
United States	Duluth Clinic	Duluth	Minnesota
United States	Miller-Dwan Medical Center	Duluth	Minnesota
United States	St. Mary's/Duluth Clinic Health System	Duluth	Minnesota
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	Luther Hospital	Eau Claire	Wisconsin
United States	Midelfort Clinic	Eau Claire	Wisconsin
United States	Fairview-Southdale Hospital	Edina	Minnesota
United States	St. Anthony's Memorial Hospital	Effingham	Illinois
United States	Trinitas Hospital - Jersey Street Campus	Elizabeth	New Jersey
United States	Northwest Oncology and Hematology, S.C.	Elk Grove Village	Illinois
United States	Swedish Medical Center	Englewood	Colorado
United States	Eureka Hospital	Eureka	Illinois
United States	CCOP - Evanston	Evanston	Illinois
United States	Therapy Associates Hematology/Oncology	Evansville	Indiana
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Meritcare Roger Maris Cancer Center	Fargo	North Dakota
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Fergus Falls Medical Group	Fergus Falls	Minnesota
United States	Woman Wise Blanchard Valley Regional Health Center	Findlay	Ohio
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Genesee Regional Medical Center	Flint	Michigan
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Poudre Valley Radiation Oncology	Fort Collins	Colorado
United States	Rocky Mountain Cancer Centers - Northern Colorado	Fort Collins	Colorado
United States	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Fremont Area Medical Center	Fremont	Nebraska
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Mercy/Unity Hospitals	Fridley	Minnesota
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	Glenbrook Hospital	Glenview	Illinois
United States	Altru Cancer Center	Grand Forks	North Dakota
United States	Altru Health Systems	Grand Forks	North Dakota
United States	CCOP - Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	CCOP - Greenville	Greenville	South Carolina
United States	UPMC Horizon	Greenville	Pennsylvania
United States	Halstead Cancer Center of Kansas	Halstead	Kansas
United States	Pinnacle Health Hospitals	Harrisburg	Pennsylvania
United States	St. Francis Hospital and Medical Center	Hartford	Connecticut
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Mason District Hospital	Havana	Illinois
United States	Central Mesabi Medical Center	Hibbing	Minnesota
United States	Duluth Clinic - Hibbing	Hibbing	Minnesota
United States	Radiation Therapy Center	Hibbing	Minnesota
United States	Hematology Oncology Associates of Illinois-Highland Park	Highland Park	Illinois
United States	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Wayne Memorial Hospital	Honesdale	Pennsylvania
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Hopedale Medical Complex Hospital	Hopedale	Illinois
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi
United States	Baptist Regional Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Florida Health Science Center - Jacksonville	Jacksonville	Florida
United States	Faulkner Hospital	Jamaica Plain	Massachusetts
United States	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts
United States	Conemaugh Memorial Hospital	Johnstown	Pennsylvania
United States	UPCI @ UPMC Lee Hospital	Johnstown	Pennsylvania
United States	Joliet Oncology/Hematology Associates, Ltd.	Joliet	Illinois
United States	Saint Joseph Medical Center	Joliet	Illinois
United States	Silver Cross Hospital	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler AFB	Keesler Air Force Base	Mississippi
United States	Office of Sharon Cole, M.D.	Kenton	Ohio
United States	CCOP - Dayton	Kettering	Ohio
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	Franciscan Skemp Healthcare	La Crosse	Wisconsin
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	University of California San Diego Cancer Center	La Jolla	California
United States	Oncology Institute of Greater Lafayette	Lafayette	Indiana
United States	Deerpath Medical Associates	Lake Forest	Illinois
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Saint Mary Regional Center	Langhorne	Pennsylvania
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Latrobe Area Hospital	Latrobe	Pennsylvania
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Central Pennsylvania Hematology and Medical Oncology Associates	Lemoyne	Pennsylvania
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky
United States	Liberal Cancer Center of Kansas	Liberal	Kansas
United States	North Shore Oncology Hematology Associates	Libertyville	Illinois
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	Bryan LGH Medical Center	Lincoln	Nebraska
United States	Bryan LGH Medical Center East	Lincoln	Nebraska
United States	Office of Susan Hansen, M.D.	Lincoln	Nebraska
United States	Prairie View Clinic	Lincoln	Nebraska
United States	Southeast Nebraska Hematology	Lincoln	Nebraska
United States	Southeast Nebreska Hematology-Oncology Consultants, PC	Lincoln	Nebraska
United States	St. Elizabeth Regional Medical Center	Lincoln	Nebraska
United States	Wedgewood Medical Center	Lincoln	Nebraska
United States	Williamsburg Radiation Oncology Center	Lincoln	Nebraska
United States	Meeker County Memorial Hospital	Litchfield	Minnesota
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas
United States	Veterans Affairs Medical Center - Long Beach	Long Beach	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California
United States	McDonough District Hospital	Macomb	Illinois
United States	Dean Medical Center	Madison	Wisconsin
United States	Meriter Hospital	Madison	Wisconsin
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Office of E. Michael Lodish	Madison Heights	Michigan
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Schneider Children's Hospital at North Shore	Manhasset	New York
United States	St. John's Hospital	Maplewood	Minnesota
United States	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin
United States	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California
United States	Mercy Cancer Center	Mason City	Iowa
United States	North West Ohio Oncology Center	Maumee	Ohio
United States	Saint Luke's Hospital	Maumee	Ohio
United States	Loyola University Medical Center	Maywood	Illinois
United States	Lawrence Memorial Hospital of Medford/Hallmark Health Systems	Medford	Massachusetts
United States	Hematology/Oncology Associates of Illinois, LLC	Melrose Park	Illinois
United States	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee
United States	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee
United States	Mendota Community Hospital	Mendota	Illinois
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	South Jersey Regional Cancer Center	Millville	New Jersey
United States	Aurora Sinai Samaritan Medical Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Fairview University Medical Center - Riverside Campus	Minneapolis	Minnesota
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	North Memorial Research Center	Minneapolis	Minnesota
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Community Memorial Hospital	Missouri Valley	Iowa
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	Trinity Medical Center	Moline	Illinois
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Community Hospital of the Monterey Peninsula	Monterey	California
United States	Morris Hospital	Morris	Illinois
United States	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey
United States	New Britain General Hospital	New Britain	Connecticut
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Lawrence and Memorial Hospital	New London	Connecticut
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Veterans Affairs Medical Center - New York	New York	New York
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	William W. Backus Hospital	Norwich	Connecticut
United States	Hematology Oncology Associates of Illinois, LLC	Oak Park	Illinois
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma
United States	Alegent Health - Immanuel Medical Center	Omaha	Nebraska
United States	Bergan Mercy Medical Center	Omaha	Nebraska
United States	Creighton University Cancer Center	Omaha	Nebraska
United States	Oncology Hematology West, P.C.	Omaha	Nebraska
United States	St. Joseph Hospital	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Veterans Affairs Medical Center - Omaha	Omaha	Nebraska
United States	Burgess Health Center	Onawa	Iowa
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	St. Charles Hospital	Oregon	Ohio
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology & Hematology of Ottumwa, PC	Ottumwa	Iowa
United States	Ottumwa Regional Health Center	Ottumwa	Iowa
United States	Veterans Affairs Medical Center - Palo Alto	Palo Alto	California
United States	Alegent Health-Midlands Community Hospital	Papillion	Nebraska
United States	Pekin Hospital	Pekin	Illinois
United States	Affiliated Urology Specialists	Peoria	Illinois
United States	Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Midwest Radiation Oncology Physicians	Peoria	Illinois
United States	Midwest Urological Group	Peoria	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	Peoria Urological Associates	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	St. Francis Medical Center	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Veterans Affairs Medical Center - Phoenix (Hayden)	Phoenix	Arizona
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	UPMC/Passavant Hospital	Pittsburgh	Pennsylvania
United States	St. James Hospital	Pontiac	Illinois
United States	CCOP - Columbia River Program	Portland	Oregon
United States	Oregon Cancer Center	Portland	Oregon
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	Pratt Cancer Center of Kansas	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Rhode Island Hospital	Providence	Rhode Island
United States	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Riverview Medical Center - Booker Cancer Center	Red Bank	New Jersey
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	Veterans Affairs Medical Center - Richmond	Richmond	Virginia
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	Trinity Medical Center	Rock Island	Illinois
United States	Swedish-American Health System	Rockford	Illinois
United States	Sarah D. Culbertson Memorial Hospital	Rushville	Illinois
United States	University of California Davis Medical Center	Sacramento	California
United States	Balcueva Clinic	Saginaw	Michigan
United States	St. Mary's Medical Center	Saginaw	Michigan
United States	CentraCare Health Plaza	Saint Cloud	Minnesota
United States	St. Cloud Hospital	Saint Cloud	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Park Nicollet Clinic	Saint Louis Park	Minnesota
United States	Healtheast Cancer Care	Saint Paul	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care, Inc.	Sandusky	Ohio
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania
United States	Moses Taylor Hospital	Scranton	Pennsylvania
United States	Scranton Hematology-Oncology	Scranton	Pennsylvania
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	St. Luke's Regional Medical 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	Sioux Valley Clinic	Sioux Falls	South Dakota
United States	Sioux Valley Hospital	Sioux Falls	South Dakota
United States	Edward H. Kaplan MD and Associates	Skokie	Illinois
United States	Hematology Oncology Associates - Skokie	Skokie	Illinois
United States	Midwest Cancer Research Group, Inc.	Skokie	Illinois
United States	Providence Hospital - Southfield	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	Geisinger Medical Group	State College	Pennsylvania
United States	Flower Hospital - Pro Medica Health System	Sylvania	Ohio
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	Madigan Army Medical Center	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Morton Hospital & Medical Center	Taunton	Massachusetts
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Veterans Affairs Medical Center - Temple	Temple	Texas
United States	Veterans Affairs Medical Center - Togus	Togus	Maine
United States	Haematology-Oncology Associates, Inc.	Toledo	Ohio
United States	MCO Cancer Institute	Toledo	Ohio
United States	Medical College of Ohio Hospital	Toledo	Ohio
United States	Riverside Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Inc.	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Northwestern Connecticut Oncology-Hematology Associates	Torrington	Connecticut
United States	David Grant Medical Center	Travis Air Force Base	California
United States	St. Francis Medical Center	Trenton	New Jersey
United States	Arizona Cancer Center	Tucson	Arizona
United States	Veterans Affairs Medical Center - Tucson	Tucson	Arizona
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	Carle Cancer Center	Urbana	Illinois
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Southern Oncology-Hematology Associates, P.A.	Vineland	New Jersey
United States	Comprehensive Cancer and Hematology Associates	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	St. John Macomb Hospital	Warren	Michigan
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	UW Cancer Center Wausau Hospital	Wausau	Wisconsin
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Chester County Hospital	West Chester	Pennsylvania
United States	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont
United States	Associates in Women's Health - Wichita	Wichita	Kansas
United States	Cancer Center of Kansas - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Veterans Affairs Medical Center - Wichita	Wichita	Kansas
United States	Via Christi Regional Medical Center	Wichita	Kansas
United States	Wichita Clinic Cancer Medicine Associates, P.A.	Wichita	Kansas
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Burlington County Hematology Oncology Association, P.A.	Willingboro	New Jersey
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (3)

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

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  South Africa, 

References & Publications (29)

An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31. — View Citation

Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.

Delaunoit T, Alberts SR, Sargent DJ, Green E, Goldberg RM, Krook J, Fuchs C, Ramanathan RK, Williamson SK, Morton RF, Findlay BP. Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741. Ann Oncol. 2005 Mar;16(3):4 — View Citation

Delaunoit T, Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Findlay BP, Thomas SP, Salim M, Schaefer PL, Stella PJ, Green E, Mailliard JA. Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or — View Citation

Dy GK, Krook J, Green E, et al.: Impact of complete response to chemotherapy on overall survival (OS) in advanced colorectal cancer (CRC): results from Intergroup N9741. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Sympos

Dy GK, Krook JE, Green EM, Sargent DJ, Delaunoit T, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pockaj BA, Sticca RP, Alberts SR, Pitot HC 4th, Goldberg RM; Intergroup N9741. Impact of complete response to chemotherapy on overall surviv — View Citation

Franko J, Shi Q, Goldman CD, et al.: Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: A pooled analysis of NCCTG's phase III trials N9741 and N9841. [Abstract] J Clin Oncol 29 (Suppl 15): A-3571, 2011.

Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12. — View Citation

Fuchs C, Pollak M, Sargent DJ, et al.: Insulin-like growth factor-I (IGF-1), IGF binding protein-3 (IGFBP-3), and outcome in metastatic colorectal cancer (CRC): results from intergroup trial N9741. [Abstract] J Clin Oncol 22 (Suppl 14): A-3521, 250s, 2004

Fuchs CS, Goldberg RM, Sargent DJ, Meyerhardt JA, Wolpin BM, Green EM, Pitot HC, Pollak M. Plasma insulin-like growth factors, insulin-like binding protein-3, and outcome in metastatic colorectal cancer: results from intergroup trial N9741. Clin Cancer Re — View Citation

Goldberg R. Oxaliplatin in colorectal cancer: current studies. Oncology (Williston Park). 2000 Dec;14(12 Suppl 11):42-7. Review. — View Citation

Goldberg RM, McLeod HL, Sargent DJ, et al.: Genetic polymorphisms, toxicity, and response rate in African Americans (AA) with metastatic colorectal cancer (MCRC) compared to Caucasians (C) when treated with IFL, FOLFOX or IROX in Intergroup N9741. [Abstra

Goldberg RM, Morton RF, Sargent D, et al.: N9741: oxaliplatin (oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Initial toxicity and response data from a GI Intergroup study. [Abstract] Proceedin

Goldberg RM, Morton RF, Sargent DJ, et al.: N9741: oxaliplatin (Oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Updated efficacy and quality of life (QOL) data from an intergroup study. [Abstrac

Goldberg RM, Sargent DJ, McLeod H. Leveraging learning from a phase III colorectal cancer clinical trial: outcomes, methodology, meta-analysis and pharmacogenetics. Trans Am Clin Climatol Assoc. 2010;121:21-32; discussion 32-3. — View Citation

Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts S. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxalipla — View Citation

Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated met — View Citation

Goldberg RM, Sargent DJ, Morton RF, Green E, Sanoff HK, McLeod H, Buckner J. NCCTG Study N9741: leveraging learning from an NCI Cooperative Group phase III trial. Oncologist. 2009 Oct;14(10):970-8. doi: 10.1634/theoncologist.2009-0175. Epub 2009 Oct 14. R — View Citation

Grothey A, Hedrick EE, Mass RD, et al.: Response rate using conventional criteria is a poor surrogate for clinical benefit on progression-free (PFS) and overall survival (OS) in metastatic colorectal cancer (mCRC): a comparative analysis of N9741 and AVF2107. [Abstract] J Clin Oncol 24 (Suppl 18): A-3516, 2006.

Grothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ. Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008 Jan 10;26(2):183-9. doi: 10.1200/JCO.2007.13.8099. — View Citation

Grothey A, Sargent DJ, Campbell ME, et al.: Waterfall plots provide detailed information on magnitude of response to conventional chemotherapy in colorectal cancer: lessons learned from N9741. [Abstract] American Society of Clinical Oncology 2007 Gastroin

Heun JM, Grothey A, Branda ME, Goldberg RM, Sargent DJ. Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741. Oncologist. 2011;16(6):859-67. doi: 10.1634/theoncologist.2011-0064. Epub 2011 May 31. — View Citation

McLeod HL, Parodi L, Sargent DJ, et al.: UGT1A1*28, toxicity and outcome in advanced colorectal cancer: results from trial N9741. [Abstract] J Clin Oncol 24 (Suppl 18): A-3520, 2006.

McLeod HL, Sargent DJ, Marsh S, Green EM, King CR, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Thibodeau SN, Grothey A, Morton RF, Goldberg RM. Pharmacogenetic predictors of adverse events and response to chemotherapy in metastatic colorectal canc — View Citation

Morton RF, Goldberg RM, Sargent DJ, et al.: Oxaliplatin (OXAL) or CPT-11 Combined with 5FU/Leucovorin (LV) in Advanced Colorectal Cancer (CRC): an NCCTG/CALGB Study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-495, 2001.

Ng K, Sargent DJ, Goldberg RM, Meyerhardt JA, Green EM, Pitot HC, Hollis BW, Pollak MN, Fuchs CS. Vitamin D status in patients with stage IV colorectal cancer: findings from Intergroup trial N9741. J Clin Oncol. 2011 Apr 20;29(12):1599-606. doi: 10.1200/J — View Citation

Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Cli — View Citation

Sanoff HK, Sargent DJ, Green EM, McLeod HL, Goldberg RM. Racial differences in advanced colorectal cancer outcomes and pharmacogenetics: a subgroup analysis of a large randomized clinical trial. J Clin Oncol. 2009 Sep 1;27(25):4109-15. doi: 10.1200/JCO.20 — View Citation

Sargent DJ, Campbell M, Grothey A, et al.: Overall and 12 week tumor response versus actual tumor measurements as predictors of overall survival (OS) in advanced colorectal cancer (ACRC): findings from NCCTG N9741. [Abstract] American Society of Clinical

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression		Up to 5 years
Secondary	overall survival		Up to 5 years
Secondary	time to treatment failure		Up to 5 years
Secondary	response rate		Up to 5 years
Secondary	quality of life		Up to 5 years

External Links

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