Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
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 Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002976
Show 149 Study Locations
|Study Chair:||Richard R. Barakat, MD||Memorial Sloan-Kettering Cancer Center|
|Study Chair:||Scott Wadler, MD||Albert Einstein College of Medicine of Yeshiva University|
|Study Chair:||David S. Alberts, MD||University of Arizona|