Spots Global Cancer Trial Database for Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
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Trial Identification
Brief Title: Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Official Title: A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
Study ID: NCT00788671
Study Description
Brief Summary: This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the efficacy of the levonorgestrel intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC). II. To determine if response to therapy can be predicted based on the molecular profile of the tumor or by change in gene expression after therapy. SECONDARY OBJECTIVES: I. To assess quality of life outcomes in patients treated with levonorgestrel IUD. II. To document the toxicity profile of the levonorgestrel IUD in the treatment of complex atypical hyperplasia and grade 1 endometrioid endometrial cancer. III. To evaluate the molecular profile of the hysterectomy specimen of patients treated with the levonorgestrel IUD. Compare molecular profile in pretreatment tissue to hysterectomy tissue between responders and non-responders to levonorgestrel IUD therapy. IV. To evaluate long-term survival, disease status, and fertility outcomes in patients with levonorgestrel IUD. OUTLINE: Patients undergo placement of a levonorgestrel-releasing intrauterine system. After completion of study treatment, patients are followed up every 3 months for 1 year, and then periodically for up to 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Lyndon Baines Johnson General Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
The Woman's Hospital of Texas, Houston, Texas, United States
MD Anderson in Katy, Houston, Texas, United States
MD Anderson League City, Nassau Bay, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
MD Anderson in The Woodlands, The Woodlands, Texas, United States
Contact Details
Name: Shannon N Westin
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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