Treatment With Medroxyprogesterone Acetate Plus LNG-IUS in Young Women With Early Stage Endometrial Cancer
Information source: Korean Gynecologic Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Cancer
Intervention: MIrena(LNG-IUS), oral MPA (Device)
Phase: Phase 2
Status: Recruiting
Sponsored by: Korean Gynecologic Oncology Group Official(s) and/or principal investigator(s): Seok Ju Seong, MD, Principal Investigator, Affiliation: Gangnam CHA medical center
Summary
A prospective multicenter trial has been started in Korea to investigate the treatment
efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone
Acetate(MPA) in Young Women with Early Stage Endometrial Cancer.
The standard treatment for endometrial cancer is total hysterectomy and bilateral
salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young
patients who desire to preserve their potential for fertility may find this standard
treatment difficult to accept. Therefore, the conservative treatment for these patients has
remained a challenge. A number of studies have reported the effectiveness of hormonal
therapy using systemic progestin in women clinically diagnosed with early endometrial
adenocarcinoma at stage IA, grade 1, who want to maintain reproductive potential. In
addition, several recent studies reported the use of LNG-IUS to treat patients at a high
risk of perioperative complications who cannot tolerate systemic progesterone because of its
adverse effects. Nevertheless, there has been no prospective multicenter trial that
investigated the effectiveness of treatment with systemic progesterone in combination with
intrauterine progesterone in young women with endometrial cancer.
Therefore, the investigators conducted a prospective trial of the treatment of the
presumably early-stage grade 1 endometrial cancer in young women who desire to preserve
fertility by using oral MPA in combination with LNG-IUS.
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.
The primary endpoint 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.
Clinical Details
Official title: 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)
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: response rate
Secondary outcome: consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
Detailed description:
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
Eligibility
Minimum age: N/A.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Gangnam CHA medical center, Seoul, Gamnamgu, Korea, Republic of; Recruiting seok ju Seong, Email: sjseongcheil@yahoo.co.kr
Additional Information
Starting date: January 2012
Last updated: May 8, 2012
|