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

10. april 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

2108

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gynecologic Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 1997

Primær færdiggørelse (Faktiske)

1. juli 2006

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2013

Sidst verificeret

1. april 2003

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000065498
  • GOG-137A
  • E-G0137
  • SWOG-G0137

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Endometriecancer

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Rwanda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner