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

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.

Study Type: Interventional

Study Design: Treatment, Randomized

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.

Intervention(s) in this Clinical Trial

• Drug: conjugated estrogens

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Gynecologic Oncology Group

Overall Clinical Trial Officials and Contacts

Richard R. Barakat, MD Study Chair Memorial Sloan-Kettering Cancer Center  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002976

Study ID Number: CDR0000065498

ClinicalTrials.gov Identifier: NCT00002976

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database