CClinicalTrials.gg
TerminatedNCT00002976Updated Apr 11, 2013

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

A Phase 3 interventional study of conjugated estrogens in Endometrial Cancer, sponsored by Gynecologic Oncology Group. Terminated at 149 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2013-04-11.

Sponsored by Gynecologic Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,108
Allocation
Randomized
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Endometrial Cancer

Keywords

  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • endometrial adenocarcinoma
03

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's planned enrollment of 2,108 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Enrollment
2,108 participants (estimated)

Interventions

  • Drugconjugated estrogens
06

Study locations

149 sites
  • University of Alabama at Birmingham Comprehensive Cancer Center
    Birmingham, Alabama 35294-3300, United States
  • MBCCOP - Gulf Coast
    Mobile, Alabama 36688, United States
  • CCOP - Greater Phoenix
    Phoenix, Arizona 85006-2726, United States
  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
    Phoenix, Arizona 85012, United States
  • Veterans Affairs Medical Center - Tucson
    Tucson, Arizona 85723, United States
  • Arizona Cancer Center
    Tucson, Arizona 85724, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Veterans Affairs Medical Center - Little Rock (McClellan)
    Little Rock, Arkansas 72205, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90033-0804, United States
  • Veterans Affairs Medical Center - West Los Angeles
    Los Angeles, California 90073, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
  • Community Hospital of Los Gatos
    Los Gatos, California 95032, United States
  • Veterans Affairs Outpatient Clinic - Martinez
    Martinez, California 94553, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609-3305, United States
  • Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • University of California Davis Medical Center
    Sacramento, California 95817, United States
  • CCOP - Santa Rosa Memorial Hospital
    Santa Rosa, California 95403, United States
  • David Grant Medical Center
    Travis Air Force Base, California 94535, United States
  • University of Colorado Cancer Center
    Denver, Colorado 80010, United States
  • Veterans Affairs Medical Center - Denver
    Denver, Colorado 80220, United States
  • New Britain, Connecticut 06052, United States
  • MBCCOP-Howard University Cancer Center
    Washington, District of Columbia 20060, United States
  • Walter Reed Army Medical Center
    Washington, District of Columbia 20307-5001, United States
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
  • Sacred Heart Hospital of Pensacola
    Pensacola, Florida 32504, United States
  • Tampa Bay Cancer Consortium
    Saint Petersburg, Florida 33701, United States
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
  • CCOP - Atlanta Regional
    Atlanta, Georgia 30342-1701, United States
  • Dwight David Eisenhower Army Medical Center
    Fort Gordon, Georgia 30905-5650, United States
  • Medical College of Georgia Comprehensive Cancer Center
    Savannah, Georgia 31403-3089, United States
  • Cancer Research Center of Hawaii
    Honolulu, Hawaii 96813-2424, United States
  • Tripler Army Medical Center
    Honolulu, Hawaii 96859-5000, United States
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    Chicago, Illinois 60611-3013, United States
  • MBCCOP - University of Illinois at Chicago
    Chicago, Illinois 60612-7323, United States
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    Chicago, Illinois 60612, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • CCOP - Central Illinois
    Decatur, Illinois 62526, United States
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    Hines, Illinois 60141, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • CCOP - Iowa Oncology Research Association
    Des Moines, Iowa 50309-1016, United States
  • Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242-1009, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160-7390, United States
  • CCOP - Wichita
    Wichita, Kansas 67214-3882, United States
  • Veterans Affairs Medical Center - Wichita
    Wichita, Kansas 67218, United States
  • Veterans Affairs Medical Center - Lexington
    Lexington, Kentucky 40502-2236, United States
  • Albert B. Chandler Medical Center, University of Kentucky
    Lexington, Kentucky 40536-0084, United States
  • Earl K. Long Medical Center
    Baton Rouge, Louisiana 70805, United States
  • MBCCOP - LSU Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Tulane University School of Medicine
    New Orleans, Louisiana 70112, United States
  • Ochsner Clinic
    New Orleans, Louisiana 70121, United States
  • Louisiana State University Health Sciences Center - Shreveport
    Shreveport, Louisiana 71130-3932, United States
  • Veterans Affairs Medical Center - Shreveport
    Shreveport, Louisiana 71130, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    Jamaica Plain, Massachusetts 02130, United States
  • Veterans Affairs Medical Center - Ann Arbor
    Ann Arbor, Michigan 48105, United States
  • CCOP - Ann Arbor Regional
    Ann Arbor, Michigan 48106, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0912, United States
  • Veterans Affairs Medical Center - Detroit
    Detroit, Michigan 48201-1932, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Butterworth Hospital
    Grand Rapids, Michigan 49503, United States
  • CCOP - Grand Rapids Clinical Oncology Program
    Grand Rapids, Michigan 49503, United States
  • CCOP - Kalamazoo
    Kalamazoo, Michigan 49007-3731, United States
  • CCOP - Beaumont
    Royal Oak, Michigan 48073-6769, United States
  • Providence Hospital - Southfield
    Southfield, Michigan 48075-9975, United States
  • CCOP - Duluth
    Duluth, Minnesota 55805, United States
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Veterans Affairs Medical Center - Biloxi
    Biloxi, Mississippi 39531-2410, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Veterans Affairs Medical Center - Jackson
    Jackson, Mississippi 39216, United States
  • Keesler Medical Center - Keesler AFB
    Keesler AFB, Mississippi 39534-2576, United States
  • Ellis Fischel Cancer Center - Columbia
    Columbia, Missouri 65203, United States
  • Veterans Affairs Medical Center - Kansas City
    Kansas City, Missouri 64128, United States
  • CCOP - Kansas City
    Kansas City, Missouri 64131, United States
  • St. Louis University Health Sciences Center
    Saint Louis, Missouri 63110, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Department of OB-GYN
    Saint Louis, Missouri 63117, United States
  • CCOP - St. Louis-Cape Girardeau
    Saint Louis, Missouri 63141, United States
  • CCOP - Cancer Research for the Ozarks
    Springfield, Missouri 65807, United States
  • CCOP - Montana Cancer Consortium
    Billings, Montana 59101, United States
  • CCOP - Missouri Valley Cancer Consortium
    Omaha, Nebraska 68106, United States
  • Methodist Cancer Center - Omaha
    Omaha, Nebraska 68114, United States
  • Cooper Hospital/University Medical Center
    Camden, New Jersey 08103-1489, United States
  • Morristown Memorial Hospital
    Morristown, New Jersey 07962-1956, United States
  • Veterans Affairs Medical Center - Albuquerque
    Albuquerque, New Mexico 87108-5138, United States
  • MBCCOP - University of New Mexico HSC
    Albuquerque, New Mexico 87131, United States
  • Cancer Center of Albany Medical Center
    Albany, New York 12208, United States
  • State University of New York Health Science Center at Brooklyn
    Brooklyn, New York 11203, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • State University of New York Health Sciences Center - Stony Brook
    Stony Brook, New York 11794-8091, United States
  • Crouse Hospital
    Syracuse, New York 13210, United States
  • Lineberger Comprehensive Cancer Center, UNC
    Chapel Hill, North Carolina 27599-7295, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Southern Pines Women's Health Center
    Southern Pines, North Carolina 28388-0749, United States
  • CCOP - Southeast Cancer Control Consortium
    Winston-Salem, North Carolina 27104-4241, United States
  • Comprehensive Cancer Center at Wake Forest University
    Winston-Salem, North Carolina 27157-1065, United States

Showing the first 100 of 149 sites.

07

References and documents

Publications

  • 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. PubMed 16446331 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002976
Lead sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, SWOG Cancer Research Network
First posted
Jan 27, 2003
Start date
Jun 1997
Primary completion
Jul 2006
Last update
Apr 11, 2013

Study contacts

Richard R. Barakat, MD
study chair · Memorial Sloan Kettering Cancer Center
Scott Wadler, MD
study chair · Albert Einstein College of Medicine
David S. Alberts, MD
study chair · University of Arizona
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2003. You cannot join it, but the record below documents what was studied.

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