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Treatment With Medroxyprogesterone Acetate Plus LNG-IUS in Young Women With Early Stage Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT01594879
Recruitment Status : Unknown
Verified May 2012 by Korean Gynecologic Oncology Group.
Recruitment status was:  Recruiting
First Posted : May 9, 2012
Last Update Posted : May 9, 2012
Sponsor:
Information provided by (Responsible Party):
Korean Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE May 7, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date May 9, 2012
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
response rate [ Time Frame: 24months after LNG-IUS insertion with taking oral MPA ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure. [ Time Frame: every 3 month after LNG-IUS insertion with taking oral MPA ]
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment With Medroxyprogesterone Acetate Plus LNG-IUS in Young Women With Early Stage Endometrial Cancer
Official Title  ICMJE 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)
Brief 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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Cancer
Intervention  ICMJE Device: MIrena(LNG-IUS), oral MPA
  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
Other Names:
  • Mirena
  • Farlutal
Study Arms  ICMJE Experimental: Endometrial cancer, LNG-IUS with MPA
Intervention: Device: MIrena(LNG-IUS), oral MPA
Publications * Kim MK, Seong SJ, Kang SB, Bae DS, Kim JW, Nam JH, Lim MC, Lee TS, Kim S, Paek J. Six months response rate of combined oral medroxyprogesterone/levonorgestrel-intrauterine system for early-stage endometrial cancer in young women: a Korean Gynecologic-Oncology Group Study. J Gynecol Oncol. 2019 Mar;30(2):e47. doi: 10.3802/jgo.2019.30.e47. Epub 2019 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594879
Other Study ID Numbers  ICMJE KGOG2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Korean Gynecologic Oncology Group
Study Sponsor  ICMJE Korean Gynecologic Oncology Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seok Ju Seong, MD Gangnam CHA medical center
PRS Account Korean Gynecologic Oncology Group
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP