Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT00002976|
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : April 11, 2013
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 or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: conjugated estrogens||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2108 participants|
|Official Title:||A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma|
|Study Start Date :||June 1997|
|Actual Primary Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002976
|Study Chair:||Richard R. Barakat, MD||Memorial Sloan Kettering Cancer Center|
|Study Chair:||Scott Wadler, MD||Albert Einstein College of Medicine|
|Study Chair:||David S. Alberts, MD||University of Arizona|