Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate
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|ClinicalTrials.gov Identifier: NCT00483327|
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : July 1, 2016
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atypical Endometrial Hyperplasia Endometrial Carcinoma||Drug: Megestrol Acetate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Megestrol Acetate
80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
Drug: Megestrol Acetate
Other Name: Megace
- Best Pathologic Responses [ Time Frame: up to 24 months ]Patients are evaluated every 12 weeks while on treatment. The response is evaluated by endometrial biopsy or dilation and curettage (D&C)/hysteroscopy. Complete response (CR) is defined as endometrial sampling is read as normal or proliferative endometrium. Partial response (PR) is defined as the biopsy sample has changed on the endometrial evaluation scale by at least one level towards normal. Stable disease (SD) is defined as no change in pathology between the index and follow-up sample. Progressive disease (PD) is defined the follow-up sample has changed towards neoplasia on the endometrial evaluation scale by at least one level or imaging is concerning for myometrial invasion or extrauterine disease such that conservative management is no longer medically appropriate.
- Toxicity and Tolerability [ Time Frame: up to 36 months ]Patients with adverse events (AEs) which were possibly, probably, or definitely related to the treatment. AEs were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) 3.
- Duration of Response [ Time Frame: up to 4 years ]For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up.
- Number of Women Who Became Pregnant [ Time Frame: up to 3 years after the treatment for each patient ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483327
|United States, New York|
|New York, New York, United States, 10016|
|NYU Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Stephanie V Blank, M.D.||New York University|