Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.

Entry 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

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

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

Expected Enrollment

Approximately 2,108 patients will be accrued for this study.

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.

Barakat RR, Bundy BN, Spirtos NM, et al.: 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 24 (4): 587-92, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Richard Barakat, MD, Protocol chair		Ph: 212-639-2453; 800-525-2225 Email: barakatr@mskcc.org

Eastern Cooperative Oncology Group

Scott Wadler, MD, Protocol chair (Contact information may not be current)		Ph: 718-904-2754

Southwest Oncology Group

David Alberts, MD, Protocol chair		Ph: 520-626-7685; 800-622-2673

Registry Information
Official Title		A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
Trial Start Date		1997-06-23
Registered in ClinicalTrials.gov		NCT00002976
Date Submitted to PDQ		1997-06-23
Information Last Verified		2003-04-18
NCI Grant/Contract Number		CA27469

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