Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
4 other identifiers
interventional
2,108
1 country
149
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedApril 11, 2013
April 1, 2003
9.1 years
November 1, 1999
April 10, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- Eastern Cooperative Oncology Groupcollaborator
- SWOG Cancer Research Networkcollaborator
Study Sites (149)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300, United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Community Hospital of Los Gatos
Los Gatos, California, 95032, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403, United States
David Grant Medical Center
Travis Air Force Base, California, 94535, United States
University of Colorado Cancer Center
Denver, Colorado, 80010, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220, United States
Unknown Facility
New Britain, Connecticut, 06052, United States
MBCCOP-Howard University Cancer Center
Washington D.C., District of Columbia, 20060, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Sacred Heart Hospital of Pensacola
Pensacola, Florida, 32504, United States
Tampa Bay Cancer Consortium
St. Petersburg, Florida, 33701, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650, United States
Medical College of Georgia Comprehensive Cancer Center
Savannah, Georgia, 31403-3089, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7390, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084, United States
Earl K. Long Medical Center
Baton Rouge, Louisiana, 70805, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769, United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
St. Louis University Health Sciences Center
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Department of OB-GYN
St Louis, Missouri, 63117, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131, United States
Cancer Center of Albany Medical Center
Albany, New York, 12208, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091, United States
Crouse Hospital
Syracuse, New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Southern Pines Women's Health Center
Southern Pines, North Carolina, 28388-0749, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1065, United States
University of Tennessee Cancer Institute
Winston-Salem, North Carolina, 27157-1065, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288, United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501, United States
Ireland Cancer Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Kettering, Ohio, 45429, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207, United States
Good Samaritan Hospital Comprehensive Cancer Center
Portland, Oregon, 97210, United States
CCOP - Columbia River Program
Portland, Oregon, 97225, United States
OHSU Cancer Institute
Portland, Oregon, 97239, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901, United States
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, 37920, United States
Brookview Research, Inc.
Nashville, Tennessee, 37203, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587, United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009, United States
Covenant Health System
Lubbock, Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23510-1115, United States
Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
University of Virginia at Roanoke
Roanoke, Virginia, 24013, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301, United States
Related Publications (1)
Barakat RR, Bundy BN, Spirtos NM, Bell J, Mannel RS; Gynecologic Oncology Group Study. Randomized double-blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Feb 1;24(4):587-92. doi: 10.1200/JCO.2005.02.8464.
PMID: 16446331RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Richard R. Barakat, MD
Memorial Sloan Kettering Cancer Center
- STUDY CHAIR
Scott Wadler, MD
Albert Einstein College of Medicine
- STUDY CHAIR
David S. Alberts, MD
University of Arizona
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
June 1, 1997
Primary Completion
July 1, 2006
Last Updated
April 11, 2013
Record last verified: 2003-04