Treatment with medroxyprogesterone acetate plus levonorgestrel-releasing intrauterine system for early-stage endometrial cancer in young women: single-arm, prospective multicenter study: Korean gynecologic oncology group study (KGOG2009).
A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of a levonorgestrel-releasing intrauterine system plus medroxyprogesterone acetate in young women with early-stage endometrial cancer. 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 a levonorgestrel-releasing intrauterine system to treat patients at a high risk of perioperative complications who cannot tolerate systemic progesterone because of its adverse effects. However, 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. Young patients with histologically confirmed Grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve their fertility potential, undergo levonorgestrel-releasing intrauterine system insertion and are administered medroxyprogesterone acetate at a dosage of 500 mg/day concurrently. The follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with the levonorgestrel-releasing intrauterine system in place, and dilatation and curettage after removal of the levonorgestrel-releasing intrauterine system. The primary endpoint is the complete response rate. The secondary endpoint is to estimate the consistency of the results of the office endometrial aspiration biopsy with the levonorgestrel-releasing intrauterine system in the uterus and a dilatation and curettage after removal of the levonorgestrel-releasing intrauterine system.
Department of Obstetrics and Gynecology, Gangnam CHA Medical Center, CHA University, 650-9, Yoksam-dong, Gangnam-gu, Seoul 135-913, Republic of Korea.
Mi Kyoung
MK
Kim
Seok Ju
SJ
Seong
Taek Sang
TS
Lee
Jae Weon
JW
Kim
Byung Ho
BH
Nam
Sung Ran
SR
Hong
Kwang Sun
KS
Suh
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D056910:Republic of Korea
D016912:Levonorgestrel; D017258:Medroxyprogesterone Acetate