Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate
The trial's objectives are to study the efficacy, defined as complete pathologic resolution
of disease, of a standard hormonal regimen with the progestin Megestrol Acetate (MegaceR)
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 Women's Cancer Program at the NYU School of Medicine and at the Bellevue Gynecologic
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 D&C/hysteroscopy. An endometrial biopsy is sufficient to document progressive,
stable disease or partial response. A D&C 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 ocp's
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best pathologic response rates
The time is for each patient. Patients will be reevaluated for response every 12 weeks
up to 24 months
Stephanie V Blank, M.D.
New York University
United States: Institutional Review Board
|Bellevue Hospital||New York, New York 10016|
|NYU Cancer Center||New York, New York 10016|