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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
N/A
N/A
Not Enrolling
Female
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


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 CenterTucson, Arizona  85724
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
University of California Davis Medical CenterSacramento, California  95817
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Massey Cancer CenterRichmond, Virginia  23298-0037
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort 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 CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Rochester Medical CenterRochester, New York  14642
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
OHSU Cancer InstitutePortland, Oregon  97239
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Medical College of Georgia Comprehensive Cancer CenterAugusta, Georgia  30912-4000
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Ochsner ClinicNew Orleans, Louisiana  70121
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Barrett Cancer CenterCincinnati, Ohio  45267-0502
University of Tennessee Medical Center at KnoxvilleKnoxville, Tennessee  37920
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
New Britain, Connecticut  06052
MBCCOP-Howard University Cancer CenterWashington, District of Columbia  20060
Mayo ClinicJacksonville, Florida  32224
Sacred Heart Hospital of PensacolaPensacola, Florida  32504
Tampa Bay Cancer ConsortiumSaint Petersburg, Florida  33701
Earl K. Long Medical CenterBaton Rouge, Louisiana  70805
Butterworth HospitalGrand Rapids, Michigan  49503
Department of OB-GYNSaint Louis, Missouri  63117
Crouse HospitalSyracuse, New York  13210
Southern Pines Women's Health CenterSouthern Pines, North Carolina  28388-0749
University of Tennessee Cancer InstituteWinston-Salem, North Carolina  27157-1065
Good Samaritan Hospital Comprehensive Cancer CenterPortland, Oregon  97210
CCOP - M.D. Anderson Research BaseHouston, Texas  77030-4009
Covenant Health SystemLubbock, Texas  79410
University of Virginia at RoanokeRoanoke, Virginia  24013