Treatment With Medroxyprogesterone Acetate(MPA) Plus Levonorgestrel-releasing Intrauterine System(LNG-IUS) in Young Women With Early Stage Endometrial Cancer: Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2009)
PURPOSE: This prospective study aims to analyze the treatment efficacy of LNG-IUS plus MPA
in Young Women with Early Stage Endometrial Cancer and to analyze the diagnostic accuracy of
office endometrial aspiration biopsy with LNG-IUS in place compared with dilatation and
curettage after removal of LNG-IUS.
ENDPOINTS: The primary endpoints of this study is response rate. Secondary endpoint is to
estimate the consistency of the results between office endometrial aspiration biopsy and
dilatation and curettage (D&C) procedure.
STUDY SETTING AND PROTOCOL REVIEW: This study is a single arm, prospective
multi-institutional study. Its protocol was approved by the Institutional Review Board of
each clinical trial institution.
PLANNED CLINICAL TRIAL PERIOD: Patient Selection and Enrollment: 24 month after IRB approval
of clinical trial Institution.
TREATMENT METHODS: Patients with histologically confirmed grade 1 endometrioid
adenocarcinoma that is presumably confined to the endometrium went through LNG-IUS insertion
and were administered MPA at a dosage of 500 mg/day concurrently. Follow-up and treatment
response assessment were implemented at a 3-month interval with transvaginal
ultrasonography, endometrial aspiration biopsy with LNG-IUS in place and D&C after removal
of LNG-IUS. The biopsy findings are compared.
1. General Name/Brand name: Mirena - SCHERING
Active ingredient: levonorgestrel 52mg
Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal
thread is attached to a loop at the end of the vertical stem of the T-body.
2. General Name/Brand name:Farlutal tab. 500mg/ Pfizer
Active ingredient: Medroxyprogesterone Acetate
PLANNED NUMBER OF SUBJECT 39 patients with biopsy proven grade 1 endometrioid adenocarcinoma
that is presumably confined to the endometrium.
STATISTICAL CONSIDERATIONS The primary objective of this study is to estimate the treatment
efficacy of the oral MPA in combination with LNG-IUS in early stage endometrial cancer in
terms of their response rate. The sample size needed for this estimation would be 39
patients after considering 10% of follow-up loss. The Secondary objective is to estimate the
consistency of the office endometrial aspiration biopsy and D&C. Kappa statistics will be
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve fertility potential go through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after removal of LNG-IUS.
24months after LNG-IUS insertion with taking oral MPA
Seok Ju Seong, MD
Gangnam CHA medical center
Korea: Food and Drug Administration