NCT00002976

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,108 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	conjugated estrogens

Timeline

• Start date: 1997-06-01
• Primary completion: 2006-07-01
• First posted: 2003-01-27
• Last updated: 2013-04-11

Locations

149 sites across 1 country: United States