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

This study has been terminated.
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Information provided by:
Gynecologic Oncology Group Identifier:
First received: November 1, 1999
Last updated: April 10, 2013
Last verified: April 2003

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.

Condition Intervention Phase
Endometrial Cancer Drug: conjugated estrogens Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 2108
Study Start Date: June 1997
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • No acute liver disease


  • Not specified


  • No prior thromboembolic disease


  • No prior or current carcinoma of the breast
  • No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • No concurrent hormonal therapy


  • Not specified


  • See Disease Characteristics
  • Recovered from prior surgery


  • No prior cancer treatment that would preclude study therapy
  • Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002976

  Show 149 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Study Chair: Richard R. Barakat, MD Memorial Sloan Kettering Cancer Center
Study Chair: Scott Wadler, MD Albert Einstein College of Medicine, Inc.
Study Chair: David S. Alberts, MD University of Arizona
  More Information

Publications: Identifier: NCT00002976     History of Changes
Other Study ID Numbers: CDR0000065498
Study First Received: November 1, 1999
Last Updated: April 10, 2013

Keywords provided by Gynecologic Oncology Group:
stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017