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

Sponsor:	Gynecologic Oncology Group
Collaborators:	National Cancer Institute (NCI) Eastern Cooperative Oncology Group Southwest Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002976

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 III

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:

MedlinePlus related topics: Cancer

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	2108
Study Start Date:	June 1997

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

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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 of Yeshiva University
Study Chair:	David S. Alberts, MD	University of Arizona

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma

Additional relevant MeSH terms:

Adenocarcinoma
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases

Genital Diseases, Female
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012