Post on 22-Dec-2015
A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight
Loss in Patients with Early Stage Cancer of the Endometrium
Study Chair: Andreas ObermairTrial Manager: Fiona MenziesTrial Coordinator: Kerry Millgate
BackgroundEndometrial cancer common in AUS Becoming increasingly common in young
women still desiring fertility Becoming common in elderly patients
suffering from significant medical co-morbidities (increased surgical risks)
Problem area: Super obese patients Surgical complications high Conversion to open surgery high Hospital stay + Costs significant
Adverse events are common
Morbidly obese woman EAC FIGO g1, no myoinvasion
Respiratory failure secondary to pneumonia
Unplanned ICU admission on day 5; Requires ventilation, imaging, i.v. ABs
Treatment alternative is availabale
Progestins offered on case-to-case basis
(Mirena ± oral progestins)
Study Objectives Primary: To determine the efficacy of Mirena
IUD ± Metformin ± Weight Loss to achieve a pathological complete response (pCR) in endometrial cancer at 6 months from study treatment start.
Secondary: Endometrial cancer biomarkers will be assessed at different time points to enhance our understanding of the molecular processes and to predict a treatment response.
Study Endpoints Primary: Pathological Complete Response
Secondary: To predict the response to treatment through clinical, blood and tissue molecular biomarkers and to increase our molecular understanding of the biological pathogenesis of “early” EAC.
feMME Trial - EligibilityTarget: 95 ± 75 patients with complex
endometrial hyperplasia with atypia or grade 1 EAC
Eligibility: Complex Endometrial Hyperplasia with atypia
OR Grade 1 EAC – avoid enrolling patients with advanced disease
who need expedited surgery
Patients at high surgical risks or wish to retain fertility
BMI > 30 kg/m2 CT scan: absence of extrauterine disease MRI: Myometrial invasion <50% Serum CA125 ≤30 U/mL
ContactAndreas Obermair: obermair@powerup.com.auAcknowledgements: QUT (M Janda), ANZGOG (RAC, Val Gebski)Endorsed by ANZGOG and ASGONational Ethics Application (covers NSW, VIC)QCGC will facilitate HREC applications in other states