Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003179
Status:
TERMINATED
Last Update Posted:
2013-06-10
First Post:
1999-11-01
Brief Title:
Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia Part A A Prospective Study of Immediate Hysterectomy Part B A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera
Status:
TERMINATED
Status Verified Date:
2006-07
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia
PURPOSE Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia
PURPOSE Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia
Detailed Description:
OBJECTIVES
Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients diagnosed at initial biopsy to have complex atypical hyperplasia
Compare the histologic response rates in patients with atypical endometrial hyperplasia treated with oral medroxyprogesterone acetate Provera vs intramuscular medroxyprogesterone acetate suspension Depo-Provera
OUTLINE This is a randomized two-part study
Part A Patients undergo immediate hysterectomy
Part B Patients are randomized to 1 of 2 arms
Arm I Patients receive oral medroxyprogesterone acetate Provera once daily for 3 months
Arm II Patients receive medroxyprogesterone acetate suspension Depo- Provera intramuscularly once monthly for 3 months days 1 31 and 62
Patients undergo hysterectomy at the end of the third month
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 360 patients for part A and 140 patients 70 per arm for part B will be accrued for this study
Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients diagnosed at initial biopsy to have complex atypical hyperplasia
Compare the histologic response rates in patients with atypical endometrial hyperplasia treated with oral medroxyprogesterone acetate Provera vs intramuscular medroxyprogesterone acetate suspension Depo-Provera
OUTLINE This is a randomized two-part study
Part A Patients undergo immediate hysterectomy
Part B Patients are randomized to 1 of 2 arms
Arm I Patients receive oral medroxyprogesterone acetate Provera once daily for 3 months
Arm II Patients receive medroxyprogesterone acetate suspension Depo- Provera intramuscularly once monthly for 3 months days 1 31 and 62
Patients undergo hysterectomy at the end of the third month
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 360 patients for part A and 140 patients 70 per arm for part B 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 |
|---|---|---|---|
| GOG-0167 | None | None | None |