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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01011478
Other study ID # NSABP-P-5
Secondary ID NSABP P-5NCI-201
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 2010
Est. completion date February 2015

Study information

Verified date July 2023
Source NSABP Foundation Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that remain after surgery. It may also keep polyps from forming or colon cancer from coming back. It is not yet known whether rosuvastatin is more effective than a placebo in treating colon cancer that was removed by surgery. PURPOSE: This randomized phase III trial is studying rosuvastatin to see how well it works compared with placebo in treating patients with stage I or stage II colon cancer that was removed by surgery.


Description:

OBJECTIVES: Primary - To compare the effect of rosuvastatin vs placebo on the 5-year occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence (APMC+R) in patients with resected stage I or II colon cancer. Secondary - To determine whether the effect of rosuvastatin vs placebo is of the same magnitude in patients taking aspirin (regardless of dose) compared to patients not taking aspirin. - To determine whether taking aspirin (regardless of dose) vs no aspirin will decrease the occurrence or APMC+R and, if there is an effect, to explore the relationship to dose. - To determine the effect of rosuvastatin in patients with familial colorectal cancer. - To determine the effect of rosuvastatin in patients with microsatellite unstable tumors (i.e., tumors displaying loss of MLH1 or MSH2 expression by IHC). - To determine the relationship between rosuvastatin therapy and features of colorectal adenomas as well as the size and number of colorectal adenomas. - To compare the time to APMC+R in patients treated with rosuvastatin vs placebo. - To compare the disease-free survival of patients treated with rosuvastatin vs placebo. - To compare the overall survival of patients treated with rosuvastatin vs placebo. - To compare the rate of recurrence of colon cancer in patients treated with rosuvastatin vs placebo. - To compare the rate of second non-colorectal primary cancers in patients treated with rosuvastatin vs placebo. - To determine the effect of rosuvastatin on health-related quality of life, global quality of life, and self-reported symptoms. - To compare the incidence and severity of adverse events associated with rosuvastatin vs placebo. - To assess relevant tumor and blood markers that may affect the metabolism, activity, or effect of the study drugs, such as HMG-CoA reductase, UGT1A6, P450-2C9, PTGS2 (COX-2), and other possible markers. OUTLINE: This is a multicenter study. Patients are stratified according to family history of a first-degree relative with colorectal cancer (yes vs no), intended aspirin dose (none vs 81 mg vs 325 mg), and adjuvant therapy for colon cancer (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Group 1: Patients receive oral placebo once daily for 5 years. - Group 2: Patients receive oral rosuvastatin once daily for 5 years. Patients may complete a quality-of-life questionnaire at baseline and at 6, 12, 36, 60, and 84 months. Tumor tissue, serum, and blood samples may be collected periodically for biomarker and other analyses. After completion of study treatment, patients are followed up periodically for up to 2 years.


Recruitment information / eligibility

Status Terminated
Enrollment 406
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Patients must have the ability to swallow oral medication. - Patients must have resected adenocarcinoma of the colon staged as American Joint Committee on Cancer (AJCC) Stage 0, I, II, or III. - Patients must have had surgical resection of the colon adenocarcinoma with curative intent within 1 year prior to randomization. (Laparoscopically-assisted colectomy is permitted.) - Patients must have completed any adjuvant therapy prior to randomization. - Patients who are taking cardioprotective low-dose aspirin at study entry must not have clinically significant toxicity, as determined by the investigator, that precludes continuation of aspirin, and the patient must be willing to continue aspirin therapy (81 mg or 325 mg) throughout study therapy. - Colonoscopy requirements within 180 days prior to randomization: - The patient must have either undergone a preoperative or postoperative documented colonoscopy to the cecum (or small bowel anastomosis) with adequate bowel preparation. - All observed polyps must have been removed. (Polyps can be removed during colonoscopy or surgery performed prior to randomization.) - Postoperative serum creatinine performed within 90 days prior to randomization must be less than or equal to 1.5 x upper limit of normal (ULN) for the lab. - The following criteria for evidence of adequate hepatic function based on postoperative testing performed within 90 days prior to randomization must be met: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than or equal to 3.0 x ULN for the lab, and Total bilirubin less than or equal to 1.5 x ULN for the lab Exclusion Criteria - Tumor with the distal border located less than 12 cm from the anal verge. - Total colectomy or total proctocolectomy. - Classic Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis (i.e., 20 or more adenomas, either synchronous or metachronous), or Hereditary Nonpolyposis Colorectal Cancer (Lynch Syndrome). - Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function. - History of documented upper GI bleeding or upper GI ulcerative disease. - Statin use within 30 days prior to randomization. - Hyperlipidemia with clinical indication for statin therapy or other prescribed medication. Determination of acceptable fasting lipid values, within 90 days prior to randomization, should be in accordance with current dyslipidemia management guidelines. - Unwillingness to discontinue chronic use of nonsteroidal antiinflammatory drugs (NSAIDs) (other than cardioprotective low-dose aspirin 81 mg or 325 mg) prior to randomization. - Anticipated need for chronic use of NSAIDs (other than cardioprotective low-dose aspirin 81 mg or 325 mg). - Inadequately treated hypothyroidism, as determined by the investigator. - History of myopathy or rhabdomyolysis. - Hypersensitivity or intolerance to statins. - Chronic drug therapy with cyclosporine, coumarin anticoagulants, gemfibrozil, some other lipid-lowering therapies (fibrates or niacin), lopinavir/ritonavir, or drugs (such as ketoconazole, spironolactone, or cimetidine) that lower levels or activity of steroid hormones. - Pregnancy or lactation at the time of study entry. (Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of childbearing potential.) - Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin. - Other non-malignant systemic disease that would preclude a patient from receiving rosuvastatin or would prevent prolonged follow-up. - Administration of any investigational agent within 30 days before randomization.

Study Design


Intervention

Drug:
rosuvastatin

Other:
placebo


Locations

Country Name City State
Canada Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario
Canada Royal Victoria Hospital - Montreal Montreal Quebec
Canada Hopital du Saint-Sacrement - Quebec Quebec City Quebec
United States Oncology Services of Aberdeen Aberdeen South Dakota
United States Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania
United States McDowell Cancer Center at Akron General Medical Center Akron Ohio
United States Summa Center for Cancer Care at Akron City Hospital Akron Ohio
United States Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany Georgia
United States Hematology Oncology Associates, PC Albuquerque New Mexico
United States Lovelace Medical Center - Downtown Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States CHRISTUS Cabrini Cancer Center Alexandria Louisiana
United States Tulane Cancer Center Office of Clinical Research Alexandria Louisiana
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States American Fork Hospital American Fork Utah
United States McFarland Clinic, PC Ames Iowa
United States Kaiser Permanente Medical Center - Anaheim/Orange County Anaheim California
United States AnMed Cancer Center Anderson South Carolina
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States Regional Medical Center Anniston Alabama
United States Langlade Memorial Hospital Antigo Wisconsin
United States Kaiser Permanente - Deer Valley Antioch California
United States Randolph Hospital Asheboro North Carolina
United States Mission Hospitals - Memorial Campus Asheville North Carolina
United States CCOP - Atlanta Regional Atlanta Georgia
United States Northside Hospital Cancer Center Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Saint Joseph's Hospital of Atlanta Atlanta Georgia
United States Harold Alfond Center for Cancer Care Augusta Maine
United States MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia
United States Aurora Presbyterian Hospital Aurora Colorado
United States Rush-Copley Cancer Care Center Aurora Illinois
United States WellStar Cobb Hospital Austell Georgia
United States Kaiser Permanente Medical Center - Baldwin Park Baldwin Park California
United States Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center Baltimore Maryland
United States Kaiser Permanente at Woodlawn Medical Center Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Hematology-Oncology Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana
United States Battle Creek Health System Cancer Care Center Battle Creek Michigan
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States Overlake Cancer Center at Overlake Hospital Medical Center Bellevue Washington
United States Kaiser Permanente Medical Center - Bellflower Bellflower California
United States St. Joseph Cancer Center Bellingham Washington
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Hematology Oncology Associates of the Quad Cities Bettendorf Iowa
United States Mecosta County Medical Center Big Rapids Michigan
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Illinois CancerCare - Bloomington Bloomington Illinois
United States St. Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho
United States Central Care Cancer Center at Carrie J. Babb Cancer Center Bolivar Missouri
United States Boston University Cancer Research Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States St. Joseph's Medical Center Brainerd Minnesota
United States Olympic Hematology and Oncology Bremerton Washington
United States Veterans Affairs Medical Center - Buffalo Buffalo New York
United States Alamance Cancer Center at Alamance Regional Medical Center Burlington North Carolina
United States Lahey Clinic Medical Center - Burlington Burlington Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States Graham Hospital Canton Illinois
United States Illinois CancerCare - Canton Canton Illinois
United States Mercy Cancer Center at Mercy Medical Center Canton Ohio
United States Southeast Cancer Center Cape Girardeau Missouri
United States Illinois CancerCare - Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States East Bay Radiation Oncology Center Castro Valley California
United States Valley Medical Oncology Consultants - Castro Valley Castro Valley California
United States Sandra L. Maxwell Cancer Center Cedar City Utah
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States Providence Centralia Hospital Centralia Washington
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States Roper St. Francis Cancer Center at Roper Hospital Charleston South Carolina
United States Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina
United States Saint Luke's Hospital Chesterfield Missouri
United States Louis A. Weiss Memorial Hospital Chicago Illinois
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States Resurrection Medical Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio
United States Christ Hospital Cancer Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States United Hospital Center Clarksburg West Virginia
United States Medical Oncology and Hematology Associates - West Des Moines Clive Iowa
United States Mercy Cancer Center - West Lakes Clive Iowa
United States Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States John B. Amos Cancer Center Columbus Georgia
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States Mercy Fitzgerald Hospital Darby Pennsylvania
United States Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur Georgia
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Colorado Cancer Research Program Denver Colorado
United States Kaiser Permanente - Denver Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - St. Luke's Medical Center Denver Colorado
United States Rose Medical Center Denver Colorado
United States St. Anthony Central Hospital Denver Colorado
United States St. Joseph Hospital Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States Kent General Hospital Dover Delaware
United States Doylestown Hospital Cancer Center Doylestown Pennsylvania
United States Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill Pennsylvania
United States Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center DuBois Pennsylvania
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States St. Luke's Hospital Cancer Care Center Duluth Minnesota
United States Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg Pennsylvania
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Shore Regional Cancer Center at Memorial Hospital - Easton Easton Maryland
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Sherman Hospital Elgin Illinois
United States Alexian Brothers Radiation Oncology Elk Grove Village Illinois
United States Elkhart Clinic, LLC Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Elmhurst Hospital Center Elmhurst New York
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Swedish Medical Center Englewood Colorado
United States Ephrata Cancer Center at Ephrata Community Hospital Ephrata Pennsylvania
United States Green Bay Oncology, Limited - Escanaba Escanaba Michigan
United States Eureka Community Hospital Eureka Illinois
United States Illinois CancerCare - Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Center for Cancer Care at Exeter Hospital Exeter New Hampshire
United States Kaiser Permanente Medical Center - Fair Oaks Fairfax Virginia
United States North Bay Cancer Center Fairfield California
United States Southcoast Center for Cancer Care Fairhaven Massachusetts
United States Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River Massachusetts
United States Dakota Cancer Institute at Dakota Clinic - South University Fargo North Dakota
United States Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington Connecticut
United States Piedmont Fayette Hospital Fayetteville Georgia
United States St. Francis Hospital Federal Way Washington
United States Blanchard Valley Medical Associates Findlay Ohio
United States Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington New Jersey
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Kaiser Permanente Medical Center - Fontana Fontana California
United States Front Range Cancer Specialists Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Fort Smith Arkansas
United States Middletown Regional Hospital Franklin Ohio
United States Frederick Memorial Hospital Regional Cancer Therapy Center Frederick Maryland
United States Kaiser Permanente - Fremont Fremont California
United States Valley Medical Oncology Fremont California
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Virginia K. Crosson Cancer Center at St. Jude Medical Center Fullerton California
United States University of Florida Shands Cancer Center Gainesville Florida
United States Kaiser Permanente - Gaithersburg Medical Center Gaithersburg Maryland
United States Galesburg Clinic, PC Galesburg Illinois
United States Illinois CancerCare - Galesburg Galesburg Illinois
United States Adams Cancer Center Gettysburg Pennsylvania
United States Glendale Memorial Hospital Comprehensive Cancer Center Glendale California
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Altru Cancer Center at Altru Hospital Grand Forks North Dakota
United States St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado
United States Butterworth Hospital at Spectrum Health Grand Rapids Michigan
United States CCOP - Grand Rapids Grand Rapids Michigan
United States Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan
United States Big Sky Oncology Great Falls Montana
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Bellin Memorial Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro North Carolina
United States Bon Secours St. Francis Health System Greenville South Carolina
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States Cancer Centers of the Carolinas - Grove Commons Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Greenville Hospital Cancer Center Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Bendheim Cancer Center at Greenwich Hospital Greenwich Connecticut
United States Cancer Centers of the Carolinas - Greer Medical Oncology Greer South Carolina
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Cherry Tree Cancer Center Hanover Pennsylvania
United States Kaiser Permanente Medical Center - Harbor City Harbor City California
United States PinnacleHealth Regional Cancer Center at Polyclinic Hospital Harrisburg Pennsylvania
United States Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut
United States Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey Illinois
United States Illinois CancerCare - Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Kaiser Permanente Medical Center - Hayward Hayward California
United States Geisinger Hazleton Cancer Center Hazleton Pennsylvania
United States St. Peter's Hospital Helena Montana
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Hinsdale Hematology Oncology Associates Hinsdale Illinois
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Kaiser Permanente - Moanalua Medical Center and Clinic Honolulu Hawaii
United States OnCare Hawaii, Incorporated - Kuakini Honolulu Hawaii
United States OnCare Hawaii, Incorporated - Lusitana Honolulu Hawaii
United States Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital, Incorporated Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire
United States M. D. Anderson Cancer Center at University of Texas Houston Texas
United States St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington West Virginia
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States St. Vincent Indianapolis Hospital Indianapolis Indiana
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Dickinson County Healthcare System Iron Mountain Michigan
United States Kaiser Permanente - Irvine Irvine California
United States Foote Memorial Hospital Jackson Michigan
United States Baptist Cancer Institute - Jacksonville Jacksonville Florida
United States St. Vincent's Medical Center Jacksonville Florida
United States Queens Cancer Center of Queens Hospital Jamaica New York
United States Mercy Regional Cancer Center Janesville Wisconsin
United States Goldschmidt Cancer Center Jefferson City Missouri
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Illinois CancerCare - Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport Tennessee
United States Kinston Medical Specialists Kinston North Carolina
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Howard Community Hospital Kokomo Indiana
United States La Grange Memorial Hospital La Grange Illinois
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Lakes Region General Hospital Laconia New Hampshire
United States Kaiser Permanente - Lafayette Lafayette Colorado
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States Fairfield Medical Center Lancaster Ohio
United States Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan
United States Sparrow Regional Cancer Center Lansing Michigan
United States Doctor's Hospital of Laredo Laredo Texas
United States Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Largo Maryland
United States CCOP - Nevada Cancer Research Foundation 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 Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States St. Joseph Regional Medical Center Lewiston Idaho
United States Central Baptist Hospital Lexington Kentucky
United States Cancer Center of Kansas, PA - Liberal Liberal Kansas
United States Parvin Radiation Oncology Liberty Missouri
United States St. Rita's Medical Center Lima Ohio
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States St. Barnabas Medical Center Cancer Center Livingston New Jersey
United States St. Mary Mercy Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Sky Ridge Medical Center Lone Tree Colorado
United States Monmouth Medical Center Long Branch New Jersey
United States Hope Cancer Care Center at Longmont United Hospital Longmont Colorado
United States Kaiser Foundation Hospital - West Los Angeles Los Angeles California
United States Kaiser Permanente Medical Center - Los Angeles Los Angeles California
United States Louisville Oncology at Norton Cancer Institute - Louisville Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Illinois CancerCare - Macomb Macomb Illinois
United States McDonough District Hospital Macomb Illinois
United States Dean Medical Center - Madison Madison Wisconsin
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin
United States Immanuel St. Joseph's Mankato Minnesota
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology - Maplewood Maplewood Minnesota
United States Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta Georgia
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey
United States Upper Michigan Cancer Center at Marquette General Hospital Marquette Michigan
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa
United States Kaiser Permanente Tysons Corner Medical Center McLean Virginia
United States Cancer Center of Kansas, PA - McPherson McPherson Kansas
United States Riddle Memorial Hospital Cancer Center Media Pennsylvania
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Middlesex Hospital Cancer Center Middletown Connecticut
United States Tucker Center for Cancer Care at Orange Regional Medical Center Middletown New York
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Trinity CancerCare Center Minot North Dakota
United States Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana
United States Saint Joseph Regional Medical Center Mishawaka Indiana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Providence Cancer Center at Providence Hospital Mobile Alabama
United States Memorial Medical Center Modesto California
United States Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois
United States Illinois CancerCare - Monmouth Monmouth Illinois
United States OSF Holy Family Medical Center Monmouth Illinois
United States Louisiana State University Health Sciences Center - Monroe Monroe Louisiana
United States Forbes Regional Hospital Monroeville Pennsylvania
United States Knox Community Hospital Mount Vernon Ohio
United States Skagit Valley Hospital Cancer Care Center Mount Vernon Washington
United States Camino Medical Group - Treatment Center Mountain View California
United States El Camino Hospital Cancer Center Mountain View California
United States D.N. Greenwald Center Mukwonago Wisconsin
United States Community Hospital Munster Indiana
United States Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray Utah
United States Mercy General Health Partners Muskegon Michigan
United States Edward Hospital Cancer Center Naperville Illinois
United States Long Island Jewish Medical Center New Hyde Park New York
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Medical Center of Louisiana - New Orleans New Orleans Louisiana
United States Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana
United States New Ulm Medical Center New Ulm Minnesota
United States CCOP - Christiana Care Health Services Newark Delaware
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Newark Beth Israel Medical Center Newark New Jersey
United States Providence Newberg Medical Center Newberg Oregon
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Illinois CancerCare - Community Cancer Center Normal Illinois
United States Cancer Care Associates - Norman Norman Oklahoma
United States Southwest Virginia Regional Cancer Center at Wellmonth Health Norton Virginia
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, Incorporated Oakland California
United States CCOP - Bay Area Tumor Institute Oakland California
United States Epic Care - Oakland Oakland California
United States Highland General Hospital Oakland California
United States Kaiser Permanente Medical Center - Oakland Oakland California
United States Larry G Strieff MD Medical Corporation Oakland California
United States Tom K Lee, Incorporated Oakland California
United States Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin
United States Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden Utah
United States Cancer Care Associates - Mercy Campus Oklahoma City Oklahoma
United States Providence St. Peter Hospital Regional Cancer Center Olympia Washington
United States Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Immanuel Medical Center Omaha Nebraska
United States Lakeside Hospital Omaha Nebraska
United States Methodist Estabrook Cancer Center Omaha Nebraska
United States Kaiser Permanente - Ontario Vineyard Medical Offices and Ambulatory SurgiCenter Ontario California
United States St. Joseph Hospital Regional Cancer Center - Orange Orange California
United States Willamette Falls Hospital Oregon City Oregon
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Palo Alto Medical Foundation Palo Alto California
United States Kaiser Permanente Medical Group Panorama City California
United States Advocate Lutheran General Cancer Care Center Park Ridge Illinois
United States Parker Adventist Hospital Parker Colorado
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States Illinois CancerCare - Pekin Pekin Illinois
United States Capital Health Regional Cancer Center Pennington New Jersey
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare - Peru Peru Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst North Carolina
United States Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania
United States Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Berkshire Hematology Oncology, PC Pittsfield Massachusetts
United States Michiana Hematology Oncology PC - Plymouth Plymouth Indiana
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States CCOP - Columbia River Oncology Program Portland Oregon
United States Kaiser Permanente Health Care - Portland Portland Oregon
United States Mercy Hospital Portland Maine
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Pottstown Memorial Regional Cancer Center Pottstown Pennsylvania
United States CCOP - Kansas City Prairie Village Kansas
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Illinois CancerCare - Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Princeton Community Hospital Princeton West Virginia
United States Utah Valley Regional Medical Center - Provo Provo Utah
United States St. Mary - Corwin Regional Medical Center Pueblo Colorado
United States Good Samaritan Cancer Center Puyallup Washington
United States Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center Rancho Mirage California
United States Rapid City Regional Hospital Rapid City South Dakota
United States Kaiser Permanente Medical Center - Redwood City Redwood City California
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Annie Penn Cancer Center Reidsville North Carolina
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Kaiser Permanente Medical Center - Richmond Richmond California
United States Reid Hospital & Health Care Services Richmond Indiana
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States West Suburban Center for Cancer Care River Forest Illinois
United States Southern Regional Medical Center Riverdale Georgia
United States Kaiser Permanente Medical Center - Riverside Riverside California
United States Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Center for Cancer Care at OSF Saint Anthony Medical Center Rockford Illinois
United States Swedish-American Regional Cancer Center Rockford Illinois
United States Phelps County Regional Medical Center Rolla Missouri
United States Harbin Clinic Cancer Center - Medical Oncology Rome Georgia
United States Kaiser Permanente Medical Center - Roseville Roseville California
United States William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States Kaiser Permanente Medical Center - Sacramento Sacramento California
United States South Sacramento Kaiser-Permanente Medical Center Sacramento California
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States Dixie Regional Medical Center - East Campus Saint George Utah
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States Lakeside Cancer Specialists, PLLC Saint Joseph Michigan
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Saint Louis University Cancer Center Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States Regions Hospital Cancer Care Center Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Salem Hospital Regional Cancer Care Services Salem Oregon
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Salinas Valley Memorial Hospital Salinas California
United States Peninsula Regional Medical Center Salisbury Maryland
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego San Diego California
United States Kaiser Permanente Medical Office -Vandever Medical Office San Diego California
United States Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco California
United States Kaiser Permanente Medical Center - Santa Teresa San Jose California
United States Kaiser Permanente Health Care San Marcos California
United States Doctors Medical Center - San Pablo Campus San Pablo California
United States Kaiser Foundation Hospital - San Rafael San Rafael California
United States Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara California
United States Kaiser Permanente Medical Center - Santa Rosa Santa Rosa California
United States Florida Cancer Specialists - Sarasota Downtown Sarasota Florida
United States Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah Georgia
United States Hematology and Oncology Associates of Northeastern Pennsylvania Scranton Pennsylvania
United States Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States Cancer Centers of the Carolinas - Seneca Seneca South Carolina
United States Olympic Medical Cancer Center Sequim Washington
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States St. Nicholas Hospital Sheboygan Wisconsin
United States Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport Louisiana
United States Highland Clinic Shreveport Louisiana
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP 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 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States Somerset Medical Center Somerville New Jersey
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Kaiser Permanente Medical Center - South San Francisco South San Francisco California
United States Frederick R. and Betty M. Smith Cancer Treatment Center Sparta New Jersey
United States Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States Rockwood Clinic Cancer Treatment Center Spokane Washington
United States Illinois CancerCare - Spring Valley Spring Valley Illinois
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States St. John's Regional Health Center Springfield Missouri
United States Carl and Dorothy Bennett Cancer Center at Stamford Hospital Stamford Connecticut
United States Stanford Cancer Center Stanford California
United States Geisinger Medical Group - Scenery Park State College Pennsylvania
United States Nalitt Cancer Institute at Staten Island University Hospital Staten Island New York
United States Iredell Memorial Hospital Statesville North Carolina
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente Medical Facility - Stockton Stockton California
United States Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Allenmore Hospital Tacoma Washington
United States CCOP - Northwest Tacoma Washington
United States Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington
United States MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington
United States St. Clare Hospital Tacoma Washington
United States Celilo Cancer Center at Mid-Columbia Medical Center The Dalles Oregon
United States North Suburban Medical Center Thornton Colorado
United States J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River New Jersey
United States Cotton-O'Neil Cancer Center Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center Upland Pennsylvania
United States CCOP - Carle Cancer Center Urbana Illinois
United States Kaiser Permanente Medical Center - Vacaville Vacaville California
United States Kaiser Permanente Medical Center - Vallejo Vallejo California
United States Southwest Washington Medical Center Cancer Center Vancouver Washington
United States Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland New Jersey
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States St. Mary Regional Cancer Center at St. Mary Medical Center Walla Walla Washington
United States Kaiser Permanente Medical Center - Walnut Creek Walnut Creek California
United States St. John Macomb Hospital Warren Michigan
United States Kaiser Permanente at Capitol Hill Medical Center Washington District of Columbia
United States Washington Cancer Institute at Washington Hospital Center Washington District of Columbia
United States Covenant Cancer Treatment Center Waterloo Iowa
United States Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin
United States University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau Wisconsin
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Methodist West Hospital West Des Moines Iowa
United States Jennersville Regional Hospital West Grove Pennsylvania
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Cleveland Clinic Florida - Weston Weston Florida
United States Michiana Hematology Oncology PC - La Porte Westville Indiana
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Susquehanna Cancer Center at Divine Providence Hospital Williamsport Pennsylvania
United States Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem North Carolina
United States Riverview UW Cancer Center at Riverview Hospital Wisconsin Rapids Wisconsin
United States Minnesota Oncology - Woodbury Woodbury Minnesota
United States Kaiser Permanente Medical Cener - Woodland Hills Woodland Hills California
United States United States Air Force Medical Center - Wright-Patterson Wright-Patterson Air Force Base Ohio
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States York Cancer Center at Apple Hill Medical Center York Pennsylvania
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
NSABP Foundation Inc National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Boman BM, Bandos H, Wickerham DL, et al.: Statin polyp prevention trial in patients with resected colon cancer: NSABP protocol P-5. [Abstract] J Clin Oncol 30 (Suppl 15): A-TPS1615, 2012.

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of = 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R) Percentage of patients with occurrence of APMC+R event. APMC+R events include at least one adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence Up to 4.8 years
Secondary Size of Colorectal Adenomas, Including Advanced Adenomas The histologic size (diameter of adenoma into the wall of the colon; as per AJCC staging) of the largest adenoma among patients who have at least one adenoma detected. If histologic size was not available, the endoscopic size was provided. Up to 4.8 years
Secondary Disease-free Survival Number of patients with DFS event (colon cancer recurrence, second primary cancer, or death from any cause) Up to 4.8 years
Secondary Overall Survival (OS) Number of patients with the OS event (death from any cause) Up to 4.8 years
Secondary Recurrence-free Interval (RFI) Number of patients with the RFI event (First recurrence of colon cancer) Up to 4.8 years
Secondary Second Non-colorectal Primary Cancer-free Interval Number of patients with the first occurrence of non-colorectal primary cancer Up to 4.8 years
Secondary Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist Global Quality-of-life Scale score, ranges from 0 (worst imaginable health status) to 10 (best imaginable health status. 12-month time point
Secondary Toxicity Assessed by Adverse Events Percentage of patients with at least one grade 2 or higher adverse event reported. Up to 4.8 years
Secondary Measurements of Relevant Tumor and Blood Markers This study terminated early. Data on samples was not collected, the relevant analyses were not performed. At randomization
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