A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)
The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are
effective in reducing the 3-year event rate of high risk adenoma or second primary
colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis
will test the main effect of each agent, as well as the comparison of placebo alone to the
combination of sulindac and eflornithine.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
3-year event rate after registration among Stage 0-III colon cancer patients. (An event is defined as high-risk adenoma or second primary colorectal cancer.)
The primary objective is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in Stage 0, I, II, and III colon cancer patients.
3 years
No
Jason A. Zell, D.O., MPH
Principal Investigator
University of California, Irvine
United States: Food and Drug Administration
S0820
NCT01349881
March 2013
July 2019
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Trinity Cancer Care Center | Minot, North Dakota 58701 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Munson Medical Center | Traverse City, Michigan 49684 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Proctor Hospital | Peoria, Illinois 61614 |
Salina Regional Health Center | Salina, Kansas 67401 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Grandview Hospital | Dayton, Ohio 45405 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Holy Family Medical Center | Des Plaines, Illinois 60016 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Alaska Regional Hospital | Anchorage, Alaska 99508 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Memorial Medical Center | Springfield, Illinois 62781 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Maui Memorial Medical Center | Wailuku, Hawaii 96793 |
Hennepin County Medical Center | Minneapolis, Minnesota |
University of Rochester | Rochester, New York 14642 |
Glens Falls Hospital | Glens Falls, New York 12801 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Wayne State University | Detroit, Michigan 48202 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
California Pacific Medical Center | San Francisco, California 94115 |
Columbus CCOP | Columbus, Ohio 43206 |
Weiss Memorial Hospital | Chicago,, Illinois 60640 |
Kaiser Permanente | Sacramento, California |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Virginia Mason CCOP | Seattle, Washington 98101 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
M D Anderson Cancer Center | Houston, Texas 77030 |
University of Southern California | Los Angeles, California 90033 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Hawaii Medical Center East | Honolulu, Hawaii 96817 |
Castle Medical Center | Kailua, Hawaii 96734 |
Hays Medical Center | Hays, Kansas 67601 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Mills - Peninsula Hospitals | Burlingame, California 94010 |
Kaiser Permanente, Fremont | Fremont, California 94538 |
Kaiser Permanente, Hayward | Hayward, California 94545 |
Kaiser Permanente-Oakland | Oakland, California 94611 |
Saint Joseph Hospital | Orange, California 92868 |
Kaiser Permanente-Redwood City | Redwood City, California 94063 |
Kaiser Permanente-Richmond | Richmond, California 94801 |
Kaiser Permanente-Roseville | Roseville, California 95661 |
Kaiser Permanente-South Sacramento | Sacramento, California 95823 |
Kaiser Permanente - Sacramento | Sacramento, California 95825 |
Kaiser Permanente-San Francisco | San Francisco, California 94115 |
Kaiser Permanente-Santa Teresa-San Jose | San Jose, California 95119 |
Kaiser Permanente-San Rafael | San Rafael, California 94903 |
Kaiser Permanente-Santa Rosa | Santa Rosa, California 95403 |
Kaiser Permanente-South San Francisco | South San Francisco, California 94080 |
Kaiser Permanente-Stockton | Stockton, California 95210 |
Kaiser Permanente-Vallejo | Vallejo, California 94589 |
Kaiser Permanente-Walnut Creek | Walnut Creek, California 94596 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Phoebe Putney Memorial Hospital | Albany, Georgia 31703 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Pacific Cancer Institute of Maui | Wailuku, Hawaii 96793 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Saint Francis Hospital and Medical Center - Topeka | Topeka, Kansas 66606 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Louisiana State University Sciences Center- Monroe | Monroe, Louisiana 71210 |
Highland Clinic | Shreveport, Louisiana 71105 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Truman Medical Center | Kansas City, Missouri 64108 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Cox Medical Center | Springfield, Missouri 65807 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Good Samaritan Hospital | Kearney, Nebraska 68847 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Greenville CCOP | Greenville, South Carolina 29615 |
Greenville Memorial Hospital | Greenville, South Carolina 29605 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Auburn Regional Medical Center | Auburn, Washington 98002 |
Saint Francis Hospital | Federal Way, Washington 98003 |
Providence - Saint Peter Hospital | Olympia, Washington 98506-5166 |
Good Samaritan Community Hospital | Puyallup, Washington 98372 |
Northwest CCOP | Tacoma, Washington 98405 |
Multicare Health System | Tacoma, Washington 98415 |
Saint Clare Hospital | Tacoma, Washington 98499 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Elkhart Clinic | Elkhart, Indiana 46515 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Denver Veterans Administration Medical Center | Denver, Colorado 80220 |
Illinois CancerCare-Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare-Canton | Canton, Illinois 61520 |
Illinois CancerCare-Carthage | Carthage, Illinois 62321 |
Illinois CancerCare-Eureka | Eureka, Illinois 61530 |
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare-Macomb | Macomb, Illinois 61455 |
Illinois CancerCare-Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare-Pekin | Pekin, Illinois 61603 |
Illinois CancerCare-Peru | Peru, Illinois 61354 |
Illinois CancerCare-Princeton | Princeton, Illinois 61356 |
Michiana Hematology Oncology PC-Elkhart | Elkhart, Indiana 46514 |
Michiana Hematology Oncology PC-Plymouth | Plymouth, Indiana 46563 |
Michiana Hematology Oncology PC-South Bend | South Bend, Indiana 46601 |
Michiana Hematology Oncology-PC Westville | Westville, Indiana 46391 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas-Greer Medical Oncology | Greer, South Carolina 29650 |
University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
Kansas City Cancer Centers-Southwest | Overland Park, Kansas 66210 |
Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |
Arizona Cancer Center at UMC Orange Grove | Tucson, Arizona 85704 |
Kaiser Permanente-Deer Valley Medical Center | Antioch, California 94531 |
Kaiser Permanente Medical Center-Vacaville | Vacaville, California 95688 |
Kaiser Permanente Moanalua Medical Center | Honolulu, Hawaii 96819 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Saint Joseph Regional Medical Center | Lewiston, Idaho 83501 |
Kansas City Cancer Center-West | Kansas City, Kansas 66112 |
Kansas City Cancer Center-Shawnee Mission | Shawnee Mission, Kansas 66204 |
Kansas City Cancer Center - South | Kansas City, Missouri 64131 |
Kansas City Cancer Center-Lee's Summit | Lee's Summit, Missouri 64064 |
The Mark H Zangmeister Center | Columbus, Ohio 43219 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Saint Francis Hospital | Greenville, South Carolina 29601 |
Overlake Hospital Medical Center | Bellevue, Washington 98004 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Pacific Medical Center-First Hill | Seattle, Washington 98104 |
Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
Los Angeles County-USC Medical Center | Los Angeles, California 90033 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Alta Bates Summit Medical Center-Herrick Campus | Berkeley, California 94704 |
Michiana Hematology Oncology PC-Mishawaka | Mishawaka, Indiana 46545-1470 |
Marie Yeager Cancer Center | Saint Joseph, Michigan 49085 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Sanford Bismarck Medical Center | Bismarck, North Dakota 58501 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center-Mishawaka | Mishawaka, Indiana 46545-1470 |
Via Christi Hospital-Pittsburg | Pittsburg, Kansas 66762 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Promise Regional Medical Center-Hutchinson | Hutchinson, Kansas 65702 |
Sutter Pacific Medical Foundation | Santa Rosa, California 95403 |
Park Ridge Hospital Breast Health Center | Hendersonville, North Carolina 28792 |
OnCare Hawaii-Liliha | Honolulu, Hawaii 96817-3169 |
Saint Rose Ambulatory and Surgery Center | Great Bend, Kansas 67530 |
Cancer Center of Western Wisconsin | New Richmond, Wisconsin 54017 |
Hines Veterans Administration Hospital | Hines, Illinois 60141 |
Kaiser Permanente-Modesto | Modesto, California 95356 |