Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
NCT ID: NCT00002976
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
2108 participants
INTERVENTIONAL
1997-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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conjugated estrogens
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed grade I, II or III endometrial adenocarcinoma (endometrioid, villoglandular, mucinous, adenosquamous, papillary serous, clear cell, or not otherwise specified)
* Must have had total hysterectomy and bilateral salpingo-oophorectomy within past 20 weeks
* Surgical stage IA, IB, IC, IIA (occult), or IIB (occult) disease
* Must have had normal mammogram, or a negative breast biopsy after an abnormal mammogram, within past year
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* No acute liver disease
Renal:
* Not specified
Cardiovascular:
* No prior thromboembolic disease
Other:
* No prior or current carcinoma of the breast
* No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* No concurrent hormonal therapy
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
* Recovered from prior surgery
Other:
* No prior cancer treatment that would preclude study therapy
* Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
SWOG Cancer Research Network
NETWORK
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Richard R. Barakat, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Scott Wadler, MD
Role: STUDY_CHAIR
Albert Einstein College of Medicine
David S. Alberts, MD
Role: STUDY_CHAIR
University of Arizona
Locations
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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 D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Sacred Heart Hospital of Pensacola
Pensacola, Florida, United States
Tampa Bay Cancer Consortium
St. 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 Air Force Base, 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
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Department of OB-GYN
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, 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
Countries
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References
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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.
Other Identifiers
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GOG-137A
Identifier Type: -
Identifier Source: secondary_id
E-G0137
Identifier Type: -
Identifier Source: secondary_id
SWOG-G0137
Identifier Type: -
Identifier Source: secondary_id
CDR0000065498
Identifier Type: -
Identifier Source: org_study_id
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