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

NCT01594879 | Unknown Phase 2

• 1 other identifier: KGOG2009
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; LNG-IUS; oral MPA

Outcome Measures

Primary Outcomes (1)

• response rate

  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

Secondary Outcomes (1)

• consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.

  every 3 month after LNG-IUS insertion with taking oral MPA

Study Arms (1)

Endometrial cancer, LNG-IUS with MPA

EXPERIMENTAL

Device: MIrena(LNG-IUS), oral MPA

Interventions

MIrena(LNG-IUS), oral MPA DEVICE

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

Also known as: Mirena, Farlutal

Endometrial cancer, LNG-IUS with MPA

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients younger than 40 years
• Patients who are histological confirmed as endometrial adenocarcinoma grade I that is presumably confined to the endometrium based on the MRI evaluation
• Patients who desire to preserve fertility potential
• Patients signed the written informed consent voluntarily

You may not qualify if:

• Patients who have severe underlying disease or complication
• Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
• Acute liver disease or kidney disease
• Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker

Sponsors & Collaborators

• Korean Gynecologic Oncology Group: lead

Study Sites (1)

Gangnam CHA medical center

Seoul, Gamnamgu, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 30740964 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Seok Ju Seong, MD

  Gangnam CHA medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

KR (1)