Endometrial Adenocarcinoma Clinical Trial
Official title:
A Phase II Head-to-Head Comparison of Fertility-Sparing Approaches to Treat Complex Atypical Hyperplasia of the Edometrium: Megestrol Versus Levonorgestrel-Releasing Intrauterine System (LNG-IUS)
This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.
PRIMARY OBJECTIVES:
I. To determine if the levonorgestrel-releasing intrauterine system (IUS) results in
histologic regression of the endometrial lesion (complex atypical hyperplasia [CAH] and
grade 1 endometrial cancer [EC]) comparable to that achieved with oral megestrol (megestrol
acetate).
SECONDARY OBJECTIVES:
I. To compare both the side effect profiles, such as weight gain and mood changes as well as
compliance with assigned treatment between the 2 treatment arms.
TERTIARY OBJECTIVES:
I. To describe fertility-related outcomes, ovulation, menstrual pattern and fertility
abnormalities determined during usual workup (e.g., semen analysis), pregnancy and delivery
within 18-months of treatment.
II. To characterize the incidence of endocrine comorbidities (e.g., hypothyroidism,
polycystic ovarian syndrome, and diabetes).
III. To characterize the association of levels of endoplasmic reticular (ER) stress and
protein kinase B (Akt)-activation in endometrial samples with clinicopathologic-response to
Progestin (therapeutic progesterone) therapy.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive megestrol acetate orally (PO) twice daily (BID) for up to 18 months
in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive levonorgestrel-releasing IUS with continuous release for up to 18
months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 and 6 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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