Study on Using a Levonorgestrel-Releasing Intrauterine Device for Treating Complex Atypical Hyperplasia or Early Stage Endometrial Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT00788671
This clinical trial is exploring how well a hormone-releasing intrauterine device (IUD) works in treating patients with complex atypical hyperplasia or early stage endometrial cancer. The study aims to see if this treatment can help balance hormone levels and reduce cancer growth.
Patient Parameters
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Program Overview
This study is testing the effectiveness of a hormone-releasing intrauterine device (IUD) that releases levonorgestrel, a type of progesterone, in treating complex atypical hyperplasia and early stage endometrial cancer. High levels of estrogen can lead to the growth of endometrial cancer cells, and progesterone can help balance these hormone levels. By using levonorgestrel, the study aims to see if it can help control the cancer by regulating hormones.
Description
The main goals of this study are to see how well the levonorgestrel-releasing IUD works in treating complex atypical hyperplasia and early stage endometrial cancer, and to find out if the response to treatment can be predicted by looking at the tumor's molecular profile or changes in gene expression after treatment.
The study also aims to assess the quality of life of patients using the IUD, document any side effects, and evaluate the molecular profile of tissue samples before and after treatment. Researchers will also look at long-term outcomes, including survival, disease status, and fertility.
Participants will have the levonorgestrel-releasing IUD placed and will be monitored every 3 months for the first year, and then periodically for up to 5 years to track their progress and health.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with complex atypical hyperplasia or early stage endometrial cancer within the last three months.
- Desire to have children in the future, or have a body mass index (BMI) over 40, or have multiple health conditions.
- No previous treatment for these conditions.
- Women of any race or ethnicity.
- Able to undergo endometrial biopsies every 3 months.
- Willing to sign informed consent.
- Age over 18 years.
Exclusion Criteria
- Diagnosed with early stage endometrial cancer without meeting one of the specific criteria (desire for future fertility, high BMI, or multiple health conditions).
- Diagnosed with more advanced endometrial cancer.
- Evidence of cancer spread beyond the uterus.
- Uterine abnormalities that affect the shape of the uterine cavity.
- Active pelvic inflammatory disease.
- Acute liver disease or previously diagnosed liver tumor.
- Conditions that increase the risk of infections, such as AIDS or leukemia.
- Genital actinomycosis infection.
- Current breast cancer.
- Currently pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lyndon Baines Johnson General Hospital | 77026-1967 | Houston | Texas |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
| The Woman's Hospital of Texas | 77054 | Houston | Texas |
| MD Anderson in Katy | 77094 | Houston | Texas |
| MD Anderson League City | 77058 | Nassau Bay | Texas |
| MD Anderson in Sugar Land | 77478 | Sugar Land | Texas |
| MD Anderson in The Woodlands | 77384 | The Woodlands | Texas |
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