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)
N/A
40 Years
Female
Endometrial Cancer
Trial Information
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.
INVESTIGATIONAL PRODUCT
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
used
Inclusion Criteria:
1. Patients younger than 40 years
2. Patients who are histological confirmed as endometrial adenocarcinoma grade I that is
presumably confined to the endometrium based on the MRI evaluation
3. Patients who desire to preserve fertility potential
4. Patients signed the written informed consent voluntarily
Exclusion Criteria:
1. Patients who have severe underlying disease or complication
2. Under treatment of metastatic cancer from other organs or less than 5 years after
previous cancer therapy
3. Acute liver disease or kidney disease
4. Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate
Outcome Description:
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.
Outcome Time Frame:
24months after LNG-IUS insertion with taking oral MPA
Safety Issue:
No
Principal Investigator
Seok Ju Seong, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gangnam CHA medical center
Authority:
Korea: Food and Drug Administration
Study ID:
KGOG2009
NCT ID:
NCT01594879
Start Date:
January 2012
Completion Date:
December 2014
Related Keywords:
- Endometrial Cancer
- Endometrial cancer
- LNG-IUS
- oral MPA
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
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