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Sponsored by: |
St George's, University of London |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00566644 |
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 to observation alone in preventing atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome.
Condition | Intervention | Phase |
Endometrial Cancer Hereditary Non-Polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2) |
Drug: levonorgestrel-releasing intrauterine system Procedure: observation Procedure: questionnaire administration |
Phase III |
Genetics Home Reference related topics: | Lynch syndrome |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Levonorgestrel |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control |
Official Title: | Prevention of Endometrial Tumors (POET) |
Estimated Enrollment: | 600 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified by center and menopausal status. Patients are randomized to 1 of 2 arms.
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
Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets both of the following criteria:
Has a family history of Lynch syndrome according to the following Amsterdam or modified Amsterdam criteria:
No active genital malignancy, breast carcinoma, or other estrogen dependent tumor
PATIENT CHARACTERISTICS:
No clinically significant submucous myomas requiring treatment
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |||||
Addenbrooke's Hospital | Recruiting | ||||
Cambridge, England, United Kingdom, CB2 2QQ | |||||
Contact: Contact Person 44-1223-216-251 | |||||
Basildon University Hospital | Recruiting | ||||
Basildon, England, United Kingdom, SS16 5NL | |||||
Contact: Contact Person 44-1702-221-631 | |||||
Chelsea Westminster Hospital | Recruiting | ||||
London, England, United Kingdom, SW10 9NH | |||||
Contact: Contact Person 44-20-8846-7891 | |||||
Cheltenham General Hospital | Recruiting | ||||
Cheltenham, England, United Kingdom, GL53 7AN | |||||
Contact: Contact Person 44-8454-223-610 | |||||
City Hospital - Birmingham | Recruiting | ||||
Birmingham, England, United Kingdom, B18 7QH | |||||
Contact: Contact Person 44-121-554-3801 | |||||
Liverpool Women's Hospital | Recruiting | ||||
Liverpool, England, United Kingdom, LV8 7SS | |||||
Contact: Contact Person 44-151-252-5514 | |||||
Great Western Hospital | Recruiting | ||||
Swindon, England, United Kingdom, SN3 6BB | |||||
Contact: Contact Person 44-1793-604-950 | |||||
Guy's Hospital | Recruiting | ||||
London, England, United Kingdom, SE1 9RT | |||||
Contact: Contact Person 44-20-7188-1364 | |||||
Leeds Cancer Centre at St. James's University Hospital | Recruiting | ||||
Leeds, England, United Kingdom, LS9 7TF | |||||
Contact: Contact Person 44-113-206-6214 | |||||
Elizabeth Garrett Anderson Hospital | Recruiting | ||||
London, England, United Kingdom, WC1E 6DH | |||||
Contact: Contact Person 44-20-7380-6925 | |||||
Queen Elizabeth Hospital | Recruiting | ||||
Gateshead-Tyne and Wear, England, United Kingdom, NE9 6SX | |||||
Contact: Contact Person 44-191-445-2392 | |||||
Royal Devon and Exeter Hospital | Recruiting | ||||
Exeter, England, United Kingdom, EX2 5DW | |||||
Contact: Contact Person 44-1392-405-727 | |||||
Royal Marsden - Surrey | Recruiting | ||||
Sutton, England, United Kingdom, SM2 5PT | |||||
Contact: Contact Person 44-20-8661-3642 | |||||
Southend University Hospital NHS Foundation Trust | Recruiting | ||||
Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |||||
Contact: Contact Person 44-1702-221-631 | |||||
St. Georges, University of London | Recruiting | ||||
London, England, United Kingdom, SW17 ORE | |||||
Contact: Contact Person 44-208-725-5279 | |||||
St. Mary's Hospital | Recruiting | ||||
Manchester, England, United Kingdom, M13 0JH | |||||
Contact: Contact Person 44-161-276-5163 | |||||
United Kingdom, Northern Ireland | |||||
Belfast City Hospital Trust Incorporating Belvoir Park Hospital | Recruiting | ||||
Belfast, Northern Ireland, United Kingdom, BT8 8JR | |||||
Contact: Contact Person 44-28-9026-3872 | |||||
United Kingdom, Scotland | |||||
Aberdeen Royal Infirmary | Recruiting | ||||
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |||||
Contact: Contact Person 44-1224-552-120 | |||||
United Kingdom, Wales | |||||
University Hospital of Wales | Recruiting | ||||
Cardiff, Wales, United Kingdom, CF14 4XW | |||||
Contact: Contact Person 44-29-2074-4996 | |||||
Ysbyty Gwynedd | Recruiting | ||||
Bangor, Wales, United Kingdom, LL57 2PW | |||||
Contact: Contact Person 44-1248-384-972 |
St George's, University of London |
Principal Investigator: | Shirley Hodgson, MD | St George's, University of London |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000575423, CRUK-POET, EudraCT 2006-001815-30, EU-20784 |
First Received: | November 30, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00566644 |
Health Authority: | Unspecified |
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