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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 23, 2008

Start Date ^ICMJE

June 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002976 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma

Brief 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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Endometrial Cancer

Intervention ^ICMJE

Drug: conjugated estrogens

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

2108

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002976

Responsible Party

Study ID Numbers ^ICMJE

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

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:	Richard R. Barakat, MD	Memorial Sloan-Kettering Cancer Center
Study Chair:	Scott Wadler, MD	Albert Einstein College of Medicine of Yeshiva University
Study Chair:	David S. Alberts, MD	University of Arizona

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP