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

2013年4月10日更新者：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.

研究概览

地位

终止

条件

子宫内膜癌

干预/治疗

药品：结合雌激素

详细说明

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.

研究类型

介入性

注册 (预期的)

2108

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gynecologic Oncology Group

合作者

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Southwest Oncology Group

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1997年6月1日

初级完成 (实际的)

2006年7月1日

研究注册日期

首次提交

1999年11月1日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (估计)

2013年4月11日

上次提交的符合 QC 标准的更新

2013年4月10日

最后验证

2003年4月1日