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 thera...

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Bibliographic Details
Published in:Japanese journal of clinical oncology 2012-12, Vol.42 (12), p.1215-1218
Main Authors: Kim, Mi Kyoung, Seong, Seok Ju, Lee, Taek Sang, Kim, Jae Weon, Nam, Byung Ho, Hong, Sung Ran, Suh, Kwang Sun
Format: Article
Language:English
Subjects:
Adult
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Clinical Trials as Topic
Endometrial Neoplasms - drug therapy
Female
Humans
Intrauterine Devices, Medicated
Levonorgestrel - administration & dosage
Medroxyprogesterone Acetate - administration & dosage
Multicenter Studies as Topic
Prospective Studies
Republic of Korea
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Summary: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.
ISSN:0368-2811
1465-3621
DOI:10.1093/jjco/hys171