Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002976
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
1999-11-01
Brief Title:
Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2003-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 IBIC 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 2108 patients will be accrued for this study
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 IBIC 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 2108 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-G0137 | None | None | None |
| GOG-137A | None | None | None |
| E-G0137 | None | None | None |