Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483327
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2007-06-05
Brief Title:
Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate
Status:
COMPLETED
Status Verified Date:
2018-03
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:
The purpose of this trial is to study the efficacy toxicity and tolerability of a standard hormonal regimen of Megestrol Acetate Megace in the treatment of Atypical Endometrial Hyperplasia or well to moderately differentiated endometrial carcinoma
Detailed Description:
The trials objectives are to study the efficacy defined as complete pathologic resolution of disease of a standard hormonal regimen with the progestin Megace for the treatment of atypical endometrial hyperplasia or well or moderately differentiated endometrial carcinoma in women desiring conservative medical management of these conditions in the Womens Cancer Program at the NYU School of Medicine and at the Bellevue Gynecologic Oncology clinics
The major endpoint is pathologic complete response pCR For the purposes of this study patients will be reevaluated for response every 12 weeks until complete response Response will be assessed within 4 weeks of completion of 12 weeks of Megace by endometrial biopsy or dilation and curettage DChysteroscopy An endometrial biopsy is sufficient to document progressive stable disease or partial response A DC is necessary to confirm complete response
Patients whose disease has completely responded will discontinue treatment and be encouraged to pursue fertility Those not desiring immediate fertility will be placed on low dose oral contraceptive pills for at least 6 months Patients who have had either a partial response or stable disease will be recounseled and offered continued medical management or surgical therapy Patients whose disease has progressed will be offered definitive surgical management Those patients declining surgery will still be followed on study
The major endpoint is pathologic complete response pCR For the purposes of this study patients will be reevaluated for response every 12 weeks until complete response Response will be assessed within 4 weeks of completion of 12 weeks of Megace by endometrial biopsy or dilation and curettage DChysteroscopy An endometrial biopsy is sufficient to document progressive stable disease or partial response A DC is necessary to confirm complete response
Patients whose disease has completely responded will discontinue treatment and be encouraged to pursue fertility Those not desiring immediate fertility will be placed on low dose oral contraceptive pills for at least 6 months Patients who have had either a partial response or stable disease will be recounseled and offered continued medical management or surgical therapy Patients whose disease has progressed will be offered definitive surgical management Those patients declining surgery will still be followed on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None