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Improving the Treatment for Women With Early Stage Cancer of the Uterus (feMMe)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Queensland Centre for Gynaecological Cancer
Sponsor:
Collaborators:
The University of Queensland
Queensland University of Technology
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT01686126
First received: September 12, 2012
Last updated: October 2, 2014
Last verified: September 2014

September 12, 2012
October 2, 2014
October 2012
September 2015   (final data collection date for primary outcome measure)
Pathological complete response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01686126 on ClinicalTrials.gov Archive Site
Predict the response to treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To predict the response to treatment through blood and tissue molecular biomarkers and to increase our molecular understanding of the biological pathogenesis of "early" EAC.
Same as current
Not Provided
Not Provided
 
Improving the Treatment for Women With Early Stage Cancer of the Uterus
A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium

Currently the standard treatment for early stage endometrial cancer or endometrial hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and removal of both ovaries. While highly effective, this surgery carries significant side effects for:

  • young women who still wish to have children and would lose fertility; and
  • women with one or more disorders (or diseases) in addition to the early stage endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are at risk for surgical complications making surgery unsafe.

This study will access a new approach to the treatment of endometrial cancer to spare women of having to undergo major surgery that may be unwanted or unnecessary.

Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement therapy (HRT). However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. This research project will test to see if Mirena is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Metformin is approved in Australia to treat Diabetes. However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an experimental treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. This means that it must be tested to see if it is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Weight loss interventions are feasible and safe, and already being implemented by gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight induces a large biological effect (for example reduces incidence of diabetes by 58%, and hypertension by 26%).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Complex Endometrial Hyperplasia With Atypia
  • Grade 1 Endometrial Endometrioid Adenocarcinoma
  • Drug: Levonorgestrel
    Other Name: Mirena
  • Drug: Metformin
  • Experimental: Mirena + Metformin
    Metformin tablets, 500mg twice daily orally, 6 months Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months
    Interventions:
    • Drug: Levonorgestrel
    • Drug: Metformin
  • Experimental: Mirena
    Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months
    Intervention: Drug: Levonorgestrel
  • Experimental: Mirena + Weight Loss Intervention
    Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months Weight Loss Intervention will be delivered via Weight Watchers
    Intervention: Drug: Levonorgestrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Females with a BMI > 30 kg/m2 wishing to retain fertility or females who are at high risk of surgical complications due to co-morbidities or obesity
  2. Over 18 years of age at time of randomisation
  3. Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
  4. CT scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease
  5. Myometrial invasion on MRI of not more than 50%, for women with suspected histologically confirmed Endometrial Cancer only
  6. No lymph vascular invasion on curetting or pipelle
  7. Serum CA125 ≤ 30 U/mL
  8. No hypersensitivity or contraindications for mirena
  9. Ability to comply with endometrial biopsies at specified intervals
  10. Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
  11. No Mirena® IUD or Mirena® IUD inserted < 6 weeks prior to enrolment

Exclusion Criteria:

  1. ECOG performance status > 3
  2. Grade 1 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 2 or grade 3 endometrioid adenocarcinoma
  3. Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
  4. Pregnant or planning to become pregnant during trial period
  5. Prior treatment for EAC or EHA
  6. Patients with a history of pelvic or abdominal radiotherapy
  7. Unwilling to have additional endometrial biopsies or curettes or unable to attend three monthly clinical assessments
  8. Unable to provide informed consent or complete questionnaires
  9. Evidence of extrauterine spread on medical imaging
  10. Congenital or acquired uterine anomaly which distorts the uterine cavity
  11. Acute pelvic inflammatory disease
  12. Conditions associated with increased susceptibility to infections with microorganisms (e.g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History
  13. Genital actinomycosis
  14. Current other cancer
  15. Breastfeeding mothers
Female
18 Years and older
No
Contact: Sara L Scalzo +61 7 3646 2141 sara.scalzo@health.qld.gov.au
Contact: Trudi Cattley, BSc +61 7 3646 0447 trudi.cattley@health.qld.gov.au
Australia,   New Zealand
 
NCT01686126
feMMe
Yes
Queensland Centre for Gynaecological Cancer
Queensland Centre for Gynaecological Cancer
  • The University of Queensland
  • Queensland University of Technology
Study Chair: Andreas Obermair Queensland Centre for Gynaecological Cancer
Queensland Centre for Gynaecological Cancer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP