Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
- Conditions
- Endometrial Cancer
- Registration Number
- NCT00002976
- Lead Sponsor
- Gynecologic Oncology Group
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 2108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (148)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, 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
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 - Columbus
🇺🇸Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Covenant Health System
🇺🇸Lubbock, Texas, United States
University of Tennessee Medical Center at Knoxville
🇺🇸Knoxville, Tennessee, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
University of Virginia at Roanoke
🇺🇸Roanoke, Virginia, United States
Fletcher Allen Health Care - Medical Center Campus
🇺🇸Burlington, Vermont, United States
CCOP - M.D. Anderson Research Base
🇺🇸Houston, Texas, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Barrett Cancer Center
🇺🇸Cincinnati, Ohio, 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
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
OHSU Cancer Institute
🇺🇸Portland, Oregon, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, 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
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Sacred Heart Hospital of Pensacola
🇺🇸Pensacola, Florida, United States
MBCCOP-Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Tampa Bay Cancer Consortium
🇺🇸Saint Petersburg, Florida, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Medical College of Georgia Comprehensive Cancer Center
🇺🇸Savannah, Georgia, 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
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - 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
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Earl K. Long Medical Center
🇺🇸Baton Rouge, 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 - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Department of OB-GYN
🇺🇸Saint Louis, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, 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
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, 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
Southern Pines Women's Health Center
🇺🇸Southern Pines, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Good Samaritan Hospital Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, 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
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Tennessee Cancer Institute
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States