A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Female
Endometrial Cancer
Female
Endometrial Cancer
Trial Information
A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Richard R. Barakat, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000065498
NCT ID:
NCT00002976
Start Date:
June 1997
Completion Date:
Related Keywords:
- Endometrial Cancer
- stage I endometrial carcinoma
- stage II endometrial carcinoma
- endometrial adenocarcinoma
- Adenocarcinoma
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
| Cancer Center of Albany Medical Center | Albany, New York 12208 |
| State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Community Hospital of Los Gatos | Los Gatos, California 95032 |
| Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Brookview Research, Inc. | Nashville, Tennessee 37203 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Methodist Cancer Center - Omaha | Omaha, Nebraska 68114 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| OHSU Cancer Institute | Portland, Oregon 97239 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Medical College of Georgia Comprehensive Cancer Center | Augusta, Georgia 30912-4000 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| Eastern Virginia Medical School | Norfolk, Virginia 23507 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Ochsner Clinic | New Orleans, Louisiana 70121 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
| University of Tennessee Medical Center at Knoxville | Knoxville, Tennessee 37920 |
| Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |
| New Britain, Connecticut 06052 | |
| MBCCOP-Howard University Cancer Center | Washington, District of Columbia 20060 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Sacred Heart Hospital of Pensacola | Pensacola, Florida 32504 |
| Tampa Bay Cancer Consortium | Saint Petersburg, Florida 33701 |
| Earl K. Long Medical Center | Baton Rouge, Louisiana 70805 |
| Butterworth Hospital | Grand Rapids, Michigan 49503 |
| Department of OB-GYN | Saint Louis, Missouri 63117 |
| Crouse Hospital | Syracuse, New York 13210 |
| Southern Pines Women's Health Center | Southern Pines, North Carolina 28388-0749 |
| University of Tennessee Cancer Institute | Winston-Salem, North Carolina 27157-1065 |
| Good Samaritan Hospital Comprehensive Cancer Center | Portland, Oregon 97210 |
| CCOP - M.D. Anderson Research Base | Houston, Texas 77030-4009 |
| Covenant Health System | Lubbock, Texas 79410 |
| University of Virginia at Roanoke | Roanoke, Virginia 24013 |
