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

10 aprile 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

2108

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gynecologic Oncology Group

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 1997

Completamento primario (Effettivo)

1 luglio 2006

Date di iscrizione allo studio

Primo inviato

1 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 aprile 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 aprile 2013

Ultimo verificato

1 aprile 2003

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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