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

Phase 3
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

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


- 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


- 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

- 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



- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- No acute liver disease


- Not specified


- No prior thromboembolic disease


- No prior or current carcinoma of the breast

- No other prior invasive malignancy within the past 5 years except nonmelanoma skin


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- No concurrent hormonal therapy


- Not specified


- See Disease Characteristics

- Recovered from prior surgery


- No prior cancer treatment that would preclude study therapy

- Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Richard R. Barakat, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




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



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
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University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
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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
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Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
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St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
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Methodist Cancer Center - Omaha Omaha, Nebraska  68114
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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