Intrauterine Levonorgestrel and Observation or Observation Alone in Preventing Atypical Endometrial Hyperplasia and Endometrial Cancer in Women With Hereditary Non-Polyposis Colorectal Cancer or Lynch Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00566644|
Recruitment Status : Terminated (Withdrawn due to poor accrual)
First Posted : December 3, 2007
Last Update Posted : July 10, 2013
RATIONALE: The use of intrauterine levonorgestrel may prevent atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome. It is not yet known whether intrauterine levonorgestrel and observation are more effective than observation alone in preventing atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome.
PURPOSE: This randomized phase III trial is studying intrauterine levonorgestrel and observation to see how well they work compared with observation alone in preventing atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Hereditary Non-polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2)||Device: levonorgestrel-releasing intrauterine system Other: questionnaire administration Procedure: observation||Phase 3|
- To determine if treatment with intrauterine levonorgestrel (using the Mirena® intrauterine system [IUS]) reduces the incidence of atypical endometrial hyperplasia (AEH) and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome.
- Determine the age-related incidence of AEH and endometrial cancer in these patients.
- Determine the sensitivity and specificity of transvaginal sonography and endometrial biopsy in detecting AEH and endometrial cancer.
- Determine the premalignant pathway to carcinoma.
- Determine if the Mirena® IUS reduces the rate of therapeutic hysterectomy for AEH or endometrial cancer.
- Determine the psychological benefits or adverse effects from the use of the Mirena® IUS.
- Determine the satisfaction and compliance with screening.
- Determine the extent of adverse effects of the Mirena® IUS and observation.
- Determine the molecular changes associated with pre-malignant changes in the endometrium of these patients, and possibly the utility of tests on cervical mucus samples in diagnosing endometrial cancer.
OUTLINE: This is a multicenter study. Patients are stratified by center and menopausal status. Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo insertion of the Mirena® intrauterine device containing levonorgestrel. The device is scheduled to remain in place for 4 years. Patients also undergo observation comprising an assessment of menstrual history, transvaginal scanning (TVS), and endometrial biopsy (or hysteroscopy) at baseline and then annually for 4 years.
- Arm II: Patients undergo observation comprising an assessment of menstrual history, TVS, and endometrial biopsy (or hysteroscopy) at baseline and then annually for 4 years.
Patients complete a personal health and lifestyle questionnaire, the Life Events Scale, and the Profile of Mood States (POMS) questionnaires at baseline and periodically during study.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Endometrial Tumors (POET)|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||August 2009|
- Rate of atypical endometrial hyperplasia or endometrial cancer during the active follow-up period of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566644
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|City Hospital - Birmingham|
|Birmingham, England, United Kingdom, B18 7QH|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Cheltenham General Hospital|
|Cheltenham, England, United Kingdom, GL53 7AN|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|Queen Elizabeth Hospital|
|Gateshead-Tyne and Wear, England, United Kingdom, NE9 6SX|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Liverpool Women's Hospital|
|Liverpool, England, United Kingdom, LV8 7SS|
|London, England, United Kingdom, SE1 9RT|
|Chelsea Westminster Hospital|
|London, England, United Kingdom, SW10 9NH|
|St. Georges, University of London|
|London, England, United Kingdom, SW17 ORE|
|Elizabeth Garrett Anderson Hospital|
|London, England, United Kingdom, WC1E 6DH|
|St. Mary's Hospital|
|Manchester, England, United Kingdom, M13 0JH|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Great Western Hospital|
|Swindon, England, United Kingdom, SN3 6BB|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Belfast City Hospital Trust Incorporating Belvoir Park Hospital|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Bangor, Wales, United Kingdom, LL57 2PW|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Principal Investigator:||Shirley Hodgson, MD||St George's, University of London|