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

This study has been terminated.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00002976

First Posted: January 27, 2003

Last Update Posted: April 11, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Southwest Oncology Group

Information provided by:

Gynecologic Oncology Group

Purpose

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:

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

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:

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.

Eligibility

Information from the National Library of Medicine

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002976

Show 149 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Southwest Oncology Group

Investigators


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:

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.


ClinicalTrials.gov Identifier:	NCT00002976 History of Changes
Other Study ID Numbers:	CDR0000065498 GOG-137A E-G0137 SWOG-G0137
First Submitted:	November 1, 1999
First Posted:	January 27, 2003
Last Update Posted:	April 11, 2013
Last Verified:	April 2003

Keywords provided by Gynecologic Oncology Group:


stage I endometrial carcinoma stage II endometrial carcinoma endometrial adenocarcinoma

Additional relevant MeSH terms:


Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases	Genital Diseases, Female Estrogens Estrogens, Conjugated (USP) Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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