Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

Endometrial Carcinoma Clinical Trial

Official title: Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate

Status Completed

Clinical Trial 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.

Clinical Trial Description

The trial's 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 Women's 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 (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 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. ;

Related Conditions & MeSH terms

• Atypical Endometrial Hyperplasia
• Carcinoma
• Endometrial Carcinoma
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

• NCT number: NCT00483327
• Study type: Interventional
• Source: New York University School of Medicine
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Completion date: October 2013