Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer

Condition(s) targeted: Endometrial Cancer

Intervention: conjugated estrogens (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gynecologic Oncology Group

Official(s) and/or principal investigator(s):
Richard R. Barakat, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
Scott Wadler, MD, Study Chair, Affiliation: Albert Einstein College of Medicine of Yeshiva University
David S. Alberts, MD, Study Chair, Affiliation: University of Arizona

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.

Official title: A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma

Study design: Treatment, Randomized

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

MBCCOP - Gulf Coast, Mobile, Alabama 36688, United States

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States

Arizona Cancer Center, Tucson, Arizona 85724, 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

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

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

Chao Family Comprehensive Cancer Center, Orange, California 92868, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010, United States

Community Hospital of Los Gatos, Los Gatos, California 95032, United States

David Grant Medical Center, Travis Air Force Base, California 94535, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

University of California Davis Medical Center, Sacramento, California 95817, 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

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States

University of Colorado Cancer Center, Denver, Colorado 80010, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

New Britain, Connecticut 06052, United States

MBCCOP-Howard University Cancer Center, Washington, District of Columbia 20060, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5001, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States

Mayo Clinic, Jacksonville, Florida 32224, United States

Sacred Heart Hospital of Pensacola, Pensacola, Florida 32504, United States

Tampa Bay Cancer Consortium, Saint Petersburg, Florida 33701, 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

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Loyola University Medical Center, Maywood, Illinois 60153, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612-7323, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611-3013, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois 60141, 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

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7390, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40502-2236, United States

Earl K. Long Medical Center, Baton Rouge, Louisiana 70805, United States

Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana 71130-3932, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Ochsner Clinic, New Orleans, Louisiana 70121, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, 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

Butterworth Hospital, Grand Rapids, Michigan 49503, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States

CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0912, United States

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan 48105, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi 39531-2410, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

Department of OB-GYN, Saint Louis, Missouri 63117, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri 63110, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri 64128, United States

Washington University School of Medicine, Saint Louis, Missouri 63110, 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

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States

Cancer Center of Albany Medical Center, Albany, New York 12208, United States

Crouse Hospital, Syracuse, New York 13210, United States

Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

State University of New York Health Science Center at Brooklyn, Brooklyn, New York 11203, United States

State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York 11794-8091, United States

University of Rochester Medical Center, Rochester, New York 14642, 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

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

Southern Pines Women's Health Center, Southern Pines, North Carolina 28388-0749, United States

University of Tennessee Cancer Institute, Winston-Salem, North Carolina 27157-1065, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States

Barrett Cancer Center, Cincinnati, Ohio 45267-0501, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Kettering, Ohio 45429, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195-9001, United States

Ireland Cancer Center, Cleveland, Ohio 44106, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 73104, United States

University of Oklahoma College of Medicine, Oklahoma City, Oklahoma 73190, United States

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma 73104, United States

CCOP - Columbia River Program, Portland, Oregon 97225, United States

Good Samaritan Hospital Comprehensive Cancer Center, Portland, Oregon 97210, United States

OHSU Cancer Institute, Portland, Oregon 97239, United States

Veterans Affairs Medical Center - Portland, Portland, Oregon 97207, United States

Abington Memorial Hospital, Abington, Pennsylvania 19001-3788, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

Veterans Affairs Medical Center - Charleston, Charleston, South Carolina 29401-5799, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

Baptist Regional Cancer Center - Knoxville, Knoxville, Tennessee 37901, United States

Brookview Research, Inc., Nashville, Tennessee 37203, United States

University of Tennessee Medical Center at Knoxville, Knoxville, Tennessee 37920, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234-6200, United States

CCOP - M.D. Anderson Research Base, Houston, Texas 77030-4009, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, 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

University of Texas Medical Branch, Galveston, Texas 77555-0587, 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

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 - Northwest, Tacoma, Washington 98405-0986, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States

Madigan Army Medical Center, Tacoma, Washington 98431-5000, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 1997
Last updated: May 23, 2008