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)