Prevention of Endometrial Tumors (POET)
35 Years
65 Years
Female
Endometrial Cancer, Hereditary Non-polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2)
Trial Information
Prevention of Endometrial Tumors (POET)
OBJECTIVES:
Primary
- 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.
Secondary
- 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
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Proven to carry a pathogenic germline mutation in a DNA mismatch repair gene causing
Lynch syndrome (hereditary non-polyposis colorectal cancer) (usually MSH2, MLH1, or
MSH6)
- Meets both of the following criteria:
- Has a family history of Lynch syndrome according to the following Amsterdam or
modified Amsterdam criteria:
- Three relatives with a Lynch syndrome-related cancer (colorectal, small
bowel, endometrial, ovarian, urothelial, or hepatobiliary)
- One is a first-degree relative of the other two
- Two generations affected
- One relative diagnosed before age of 50
- Personal history of colorectal cancer (i.e., a large, villous, or severely
dysplastic colorectal adenoma) before the age of 40 OR history of small bowel,
hepatobiliary, or urothelial cancer AND has an affected family member with an
abnormal tumor immunohistochemistry staining for Lynch syndrome
- No active genital malignancy, breast carcinoma, or other estrogen dependent tumor
- History of genital malignancy, breast carcinoma, or other estrogen dependent
tumor allowed at the discretion of the investigator
PATIENT CHARACTERISTICS:
- Must have an intact uterus and not planning to undergo a prophylactic hysterectomy
- Not pregnant
- Not planning to become pregnant within the next 3 years
- No abortion resulting in infection within the past 3 months
- No pelvic inflammatory disease (PID) within the past 6 months or recurrent PID
- No clinically significant submucous myomas requiring treatment
- Small subserous or intramural myomas, clinically assessed as insignificant
allowed
- No known hypersensitivity to the constituents of the Mirena® IUS
- No unresolved abnormal cervical smear and/or current cervical dysplasia
- No trophoblastic disease with elevated hCG levels
- No liver tumor or other acute or severe liver disease
- No clinically significant condition or laboratory result that might, in the opinion
of the investigator, compromise patient safety, interfere with evaluations, or
prevent completion of the study
- No other active malignancy
- No history of stroke or myocardial infarction
- No history of bacterial endocarditis or severe pelvic infection after any prosthetic
valve replacement or in patients with an anatomical lesion of the heart
PRIOR CONCURRENT THERAPY:
- No other concurrent use of intrauterine devices
- No concurrent therapy for cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Rate of atypical endometrial hyperplasia or endometrial cancer during the active follow-up period of the study
Safety Issue:
No
Principal Investigator
Shirley Hodgson, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St George's, University of London
Authority:
Unspecified
Study ID:
CDR0000575423
NCT ID:
NCT00566644
Start Date:
July 2007
Completion Date:
Related Keywords:
- Endometrial Cancer
- Hereditary Non-polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2)
- endometrial cancer
- hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2)
- Colonic Neoplasms
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Endometrial Hyperplasia
- Adenoma
- Colorectal Neoplasms, Hereditary Nonpolyposis
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