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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Randomized Study of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	Not specified	NCI	GOG-137A E-G0137, SWOG-G0137, NCT00002976, GOG-0137

Trial Description

Purpose:

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.

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.

Eligibility:

• Normal mammogram, or a negative breast biopsy after an abnormal mammogram, within the past year
• No more than 20 weeks since surgery to remove the uterus, ovaries and fallopian tubes
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive estrogen by mouth once a day for 3 years. Patients in group two will receive a placebo by mouth once a day for 3 years. All patients will be evaluated every 6 months for 3 years and then once a year for 2 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

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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