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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: conjugated estrogens


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: conjugated estrogens|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma