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

10. april 2013 oppdatert av: Gynecologic Oncology Group

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

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.

Studieoversikt

Status

Avsluttet

Forhold

Livmorkreft

Intervensjon / Behandling

Legemiddel: konjugerte østrogener

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

2108

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile, Alabama, Forente stater, 36688
    - MBCCOP - Gulf Coast
- Arizona
  - Phoenix, Arizona, Forente stater, 85006-2726
    - CCOP - Greater Phoenix
  - Phoenix, Arizona, Forente stater, 85012
    - Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
  - Tucson, Arizona, Forente stater, 85724
    - Arizona Cancer Center
  - Tucson, Arizona, Forente stater, 85723
    - Veterans Affairs Medical Center - Tucson
- Arkansas
  - Little Rock, Arkansas, Forente stater, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, Forente stater, 72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Duarte, California, Forente stater, 91010
    - City of Hope Comprehensive Cancer Center
  - Los Angeles, California, Forente stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Forente stater, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Los Angeles, California, Forente stater, 90073
    - Veterans Affairs Medical Center - West Los Angeles
  - Los Gatos, California, Forente stater, 95032
    - Community Hospital of Los Gatos
  - Martinez, California, Forente stater, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, Forente stater, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange, California, Forente stater, 92868
    - Chao Family Comprehensive Cancer Center
  - Sacramento, California, Forente stater, 95817
    - University of California Davis Medical Center
  - Santa Rosa, California, Forente stater, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base, California, Forente stater, 94535
    - David Grant Medical Center
- Colorado
  - Denver, Colorado, Forente stater, 80220
    - Veterans Affairs Medical Center - Denver
  - Denver, Colorado, Forente stater, 80010
    - University of Colorado Cancer Center
- Connecticut
  - New Britain, Connecticut, Forente stater, 06052
- District of Columbia
  - Washington, District of Columbia, Forente stater, 20307-5001
    - Walter Reed Army Medical Center
  - Washington, District of Columbia, Forente stater, 20060
    - MBCCOP-Howard University Cancer Center
- Florida
  - Jacksonville, Florida, Forente stater, 32224
    - Mayo Clinic
  - Pensacola, Florida, Forente stater, 32504
    - Sacred Heart Hospital of Pensacola
  - Saint Petersburg, Florida, Forente stater, 33701
    - Tampa Bay Cancer Consortium
  - Tampa, Florida, Forente stater, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, Forente stater, 30342-1701
    - CCOP - Atlanta Regional
  - Fort Gordon, Georgia, Forente stater, 30905-5650
    - Dwight David Eisenhower Army Medical Center
  - Savannah, Georgia, Forente stater, 31403-3089
    - Medical College of Georgia Comprehensive Cancer Center
- Hawaii
  - Honolulu, Hawaii, Forente stater, 96859-5000
    - Tripler Army Medical Center
  - Honolulu, Hawaii, Forente stater, 96813-2424
    - Cancer Research Center of Hawaii
- Illinois
  - Chicago, Illinois, Forente stater, 60612-7323
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, Forente stater, 60612
    - Veterans Affairs Medical Center - Chicago (Westside Hospital)
  - Chicago, Illinois, Forente stater, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Forente stater, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  - Decatur, Illinois, Forente stater, 62526
    - CCOP - Central Illinois
  - Hines, Illinois, Forente stater, 60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood, Illinois, Forente stater, 60153
    - Loyola University Medical Center
  - Urbana, Illinois, Forente stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, Forente stater, 46202-5289
    - Indiana University Cancer Center
- Iowa
  - Des Moines, Iowa, Forente stater, 50309-1016
    - CCOP - Iowa Oncology Research Association
  - Iowa City, Iowa, Forente stater, 52242-1009
    - Holden Comprehensive Cancer Center
- Kansas
  - Kansas City, Kansas, Forente stater, 66160-7390
    - University of Kansas Medical Center
  - Wichita, Kansas, Forente stater, 67214-3882
    - CCOP - Wichita
  - Wichita, Kansas, Forente stater, 67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington, Kentucky, Forente stater, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
  - Lexington, Kentucky, Forente stater, 40502-2236
    - Veterans Affairs Medical Center - Lexington
- Louisiana
  - Baton Rouge, Louisiana, Forente stater, 70805
    - Earl K. Long Medical Center
  - New Orleans, Louisiana, Forente stater, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, Forente stater, 70121
    - Ochsner Clinic
  - New Orleans, Louisiana, Forente stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, Forente stater, 71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport, Louisiana, Forente stater, 71130
    - Veterans Affairs Medical Center - Shreveport
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02118
    - Boston Medical Center
  - Jamaica Plain, Massachusetts, Forente stater, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor, Michigan, Forente stater, 48106
    - CCOP - Ann Arbor Regional
  - Ann Arbor, Michigan, Forente stater, 48109-0912
    - University Of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Forente stater, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, Forente stater, 48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Grand Rapids, Michigan, Forente stater, 49503
    - CCOP - Grand Rapids Clinical Oncology Program
  - Grand Rapids, Michigan, Forente stater, 49503
    - Butterworth Hospital
  - Kalamazoo, Michigan, Forente stater, 49007-3731
    - CCOP - Kalamazoo
  - Royal Oak, Michigan, Forente stater, 48073-6769
    - CCOP - Beaumont
  - Southfield, Michigan, Forente stater, 48075-9975
    - Providence Hospital - Southfield
- Minnesota
  - Duluth, Minnesota, Forente stater, 55805
    - CCOP - Duluth
  - Minneapolis, Minnesota, Forente stater, 55455
    - University of Minnesota Cancer Center
- Mississippi
  - Biloxi, Mississippi, Forente stater, 39531-2410
    - Veterans Affairs Medical Center - Biloxi
  - Jackson, Mississippi, Forente stater, 39216-4505
    - University of Mississippi Medical Center
  - Jackson, Mississippi, Forente stater, 39216
    - Veterans Affairs Medical Center - Jackson
  - Keesler AFB, Mississippi, Forente stater, 39534-2576
    - Keesler Medical Center - Keesler AFB
- Missouri
  - Columbia, Missouri, Forente stater, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Kansas City, Missouri, Forente stater, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, Forente stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forente stater, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, Forente stater, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, Forente stater, 63110
    - St. Louis University Health Sciences Center
  - Saint Louis, Missouri, Forente stater, 63117
    - Department of OB-GYN
  - Springfield, Missouri, Forente stater, 65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, Forente stater, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, Forente stater, 68114
    - Methodist Cancer Center - Omaha
  - Omaha, Nebraska, Forente stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
- New Jersey
  - Camden, New Jersey, Forente stater, 08103-1489
    - Cooper Hospital/University Medical Center
  - Morristown, New Jersey, Forente stater, 07962-1956
    - Morristown Memorial Hospital
- New Mexico
  - Albuquerque, New Mexico, Forente stater, 87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque, New Mexico, Forente stater, 87131
    - MBCCOP - University of New Mexico HSC
- New York
  - Albany, New York, Forente stater, 12208
    - Cancer Center of Albany Medical Center
  - Brooklyn, New York, Forente stater, 11203
    - State University of New York Health Science Center at Brooklyn
  - New York, New York, Forente stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, Forente stater, 10032
    - Herbert Irving Comprehensive Cancer Center
  - Rochester, New York, Forente stater, 14642
    - University of Rochester Medical Center
  - Stony Brook, New York, Forente stater, 11794-8091
    - State University of New York Health Sciences Center - Stony Brook
  - Syracuse, New York, Forente stater, 13210
    - Crouse Hospital
- North Carolina
  - Chapel Hill, North Carolina, Forente stater, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Durham, North Carolina, Forente stater, 27710
    - Duke Comprehensive Cancer Center
  - Southern Pines, North Carolina, Forente stater, 28388-0749
    - Southern Pines Women's Health Center
  - Winston-Salem, North Carolina, Forente stater, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
  - Winston-Salem, North Carolina, Forente stater, 27157-1065
    - Comprehensive Cancer Center at Wake Forest University
  - Winston-Salem, North Carolina, Forente stater, 27157-1065
    - University of Tennessee Cancer Institute
- Ohio
  - Cincinnati, Ohio, Forente stater, 45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cincinnati, Ohio, Forente stater, 45267-0501
    - Barrett Cancer Center
  - Cleveland, Ohio, Forente stater, 44106
    - Ireland Cancer Center
  - Cleveland, Ohio, Forente stater, 44195-9001
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, Forente stater, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Columbus, Ohio, Forente stater, 43206
    - CCOP - Columbus
  - Dayton, Ohio, Forente stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Kettering, Ohio, Forente stater, 45429
    - CCOP - Dayton
- Oklahoma
  - Oklahoma City, Oklahoma, Forente stater, 73104
    - Oklahoma Medical Research Foundation
  - Oklahoma City, Oklahoma, Forente stater, 73104
    - Veterans Affairs Medical Center - Oklahoma City
  - Oklahoma City, Oklahoma, Forente stater, 73190
    - University of Oklahoma College of Medicine
- Oregon
  - Portland, Oregon, Forente stater, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, Forente stater, 97225
    - CCOP - Columbia River Program
  - Portland, Oregon, Forente stater, 97239
    - OHSU Cancer Institute
  - Portland, Oregon, Forente stater, 97210
    - Good Samaritan Hospital Comprehensive Cancer Center
- Pennsylvania
  - Abington, Pennsylvania, Forente stater, 19001-3788
    - Abington Memorial Hospital
  - Philadelphia, Pennsylvania, Forente stater, 19111
    - Fox Chase Cancer Center
  - Wynnewood, Pennsylvania, Forente stater, 19096
    - CCOP - MainLine Health
- South Carolina
  - Charleston, South Carolina, Forente stater, 29425-0721
    - Medical University of South Carolina
  - Charleston, South Carolina, Forente stater, 29401-5799
    - Veterans Affairs Medical Center - Charleston
  - Greenville, South Carolina, Forente stater, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, Forente stater, 29303
    - CCOP - Upstate Carolina
- South Dakota
  - Sioux Falls, South Dakota, Forente stater, 57104
    - CCOP - Sioux Community Cancer Consortium
- Tennessee
  - Knoxville, Tennessee, Forente stater, 37901
    - Baptist Regional Cancer Center - Knoxville
  - Knoxville, Tennessee, Forente stater, 37920
    - University of Tennessee Medical Center at Knoxville
  - Nashville, Tennessee, Forente stater, 37203
    - Brookview Research, Inc.
- Texas
  - Fort Sam Houston, Texas, Forente stater, 78234-6200
    - Brooke Army Medical Center
  - Galveston, Texas, Forente stater, 77555-0587
    - University of Texas Medical Branch
  - Houston, Texas, Forente stater, 77030-4009
    - CCOP - M.D. Anderson Research Base
  - Lubbock, Texas, Forente stater, 79410
    - Covenant Health System
  - San Antonio, Texas, Forente stater, 78284
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - San Antonio, Texas, Forente stater, 78284-7845
    - University of Texas Health Science Center at San Antonio
  - Temple, Texas, Forente stater, 76504
    - Veterans Affairs Medical Center - Temple
  - Temple, Texas, Forente stater, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, Forente stater, 84148
    - Veterans Affairs Medical Center - Salt Lake City
  - Salt Lake City, Utah, Forente stater, 84112-5550
    - Huntsman Cancer Institute
- Vermont
  - Burlington, Vermont, Forente stater, 05401
    - Fletcher Allen Health Care - Medical Center Campus
- Virginia
  - Charlottesville, Virginia, Forente stater, 22908
    - Cancer Center at the University of Virginia
  - Norfolk, Virginia, Forente stater, 23510-1115
    - Eastern Virginia Medical School
  - Richmond, Virginia, Forente stater, 23298-0037
    - Massey Cancer Center
  - Roanoke, Virginia, Forente stater, 24013
    - University of Virginia at Roanoke
- Washington
  - Seattle, Washington, Forente stater, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, Forente stater, 98104
    - Swedish Cancer Institute
  - Seattle, Washington, Forente stater, 98108
    - Veterans Affairs Medical Center - Seattle
  - Seattle, Washington, Forente stater, 98109-1024
    - Fred Hutchinson Cancer Research Center
  - Tacoma, Washington, Forente stater, 98431-5000
    - Madigan Army Medical Center
  - Tacoma, Washington, Forente stater, 98405-0986
    - CCOP - Northwest
- Wisconsin
  - Green Bay, Wisconsin, Forente stater, 54301
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gynecologic Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Southwest Oncology Group

Etterforskere

Studiestol: Richard R. Barakat, MD, Memorial Sloan Kettering Cancer Center
Studiestol: David S. Alberts, MD, University of Arizona

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Barakat RR, Bundy BN, Spirtos NM, Bell J, Mannel RS; Gynecologic Oncology Group Study. Randomized double-blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Feb 1;24(4):587-92. doi: 10.1200/JCO.2005.02.8464.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 1997

Primær fullføring (Faktiske)

1. juli 2006

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. april 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2013

Sist bekreftet

1. april 2003

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000065498
GOG-137A
E-G0137
SWOG-G0137

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .