Spots Global Cancer Trial Database for Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
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Trial Identification
Brief Title: Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
Official Title: A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
Study ID: NCT00002976
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.
Detailed Description: OBJECTIVES: * Determine the effect of estrogen replacement therapy on recurrence free and overall survival in women with a history of stage I or II endometrial adenocarcinoma. OUTLINE: This is a randomized, double blind study. Patients are stratified according to stage of endometrial cancer (IA vs IB/IC vs II). Patients are randomized to one of two treatment arms: * Arm I: Patients receive oral conjugated estrogens (Premarin) daily for 3 years. * Arm II: Patients receive oral placebo daily for 3 years. Patients are followed every 6 months for 3 years and then annually for 2 years. PROJECTED ACCRUAL: Approximately 2,108 patients will be accrued for this study.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
MBCCOP - Gulf Coast, Mobile, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, 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
City of Hope Comprehensive Cancer Center, Duarte, 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
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Community Hospital of Los Gatos, Los Gatos, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California Davis Medical Center, Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
, New Britain, Connecticut, United States
MBCCOP-Howard University Cancer Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Mayo Clinic, Jacksonville, Florida, United States
Sacred Heart Hospital of Pensacola, Pensacola, Florida, United States
Tampa Bay Cancer Consortium, Saint Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Medical College of Georgia Comprehensive Cancer Center, Savannah, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Earl K. Long Medical Center, Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Ochsner Clinic, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Boston Medical Center, Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Butterworth Hospital, Grand Rapids, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
Providence Hospital - Southfield, Southfield, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Department of OB-GYN, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Methodist Cancer Center - Omaha, Omaha, Nebraska, United States
Cooper Hospital/University Medical Center, Camden, New Jersey, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center, Albany, New York, United States
State University of New York Health Science Center at Brooklyn, Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
Crouse Hospital, Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Southern Pines Women's Health Center, Southern Pines, North Carolina, 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 Tennessee Cancer Institute, Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Barrett Cancer Center, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Kettering, Ohio, United States
Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
Good Samaritan Hospital Comprehensive Cancer Center, Portland, Oregon, United States
CCOP - Columbia River Program, Portland, Oregon, United States
OHSU Cancer Institute, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Baptist Regional Cancer Center - Knoxville, Knoxville, Tennessee, United States
University of Tennessee Medical Center at Knoxville, Knoxville, Tennessee, United States
Brookview Research, Inc., Nashville, Tennessee, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
CCOP - M.D. Anderson Research Base, Houston, Texas, United States
Covenant Health System, Lubbock, Texas, 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
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Eastern Virginia Medical School, Norfolk, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
University of Virginia at Roanoke, Roanoke, Virginia, 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
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
Contact Details
Name: Richard R. Barakat, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Name: Scott Wadler, MD
Affiliation: Albert Einstein College of Medicine
Role: STUDY_CHAIR
Name: David S. Alberts, MD
Affiliation: University of Arizona
Role: STUDY_CHAIR
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