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Improving the Treatment for Women With Early Stage Cancer of the Uterus

Information source: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complex Endometrial Hyperplasia With Atypia; Grade 1 Endometrial Endometrioid Adenocarcinoma

Intervention: Levonorgestrel (Drug); Metformin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Queensland Centre for Gynaecological Cancer

Official(s) and/or principal investigator(s):
Andreas Obermair, Study Chair, Affiliation: Queensland Centre for Gynaecological Cancer

Overall contact:
Sara L Scalzo, Phone: +61 7 3646 2141, Email: sara.scalzo@health.qld.gov.au

Summary

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%).

Clinical Details

Official title: A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pathological complete response

Secondary outcome: Predict the response to treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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 or MRI 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 histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion) 6. No lymph vascular invasion on curetting or pipelle, if able to be assessed on sample 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. Creatinine < 150µmol/L (1. 7 mg/dL) to be randomised into Mirena + Metformin arm (can still be eligible to be randomised to Mirena only or Mirena + Weight Loss, see section 5. 4 Other Eligibility Criteria Considerations) 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. Has had prior treatment or undergoing current treatment for EAC or EHA 6. Patients with a history of pelvic or abdominal radiotherapy 7. Unwilling to have additional endometrial biopsies or curettes and unable to attend three monthly clinical assessments 8. Unable to provide informed consent 9. Unable or unwilling to complete questionnaires 10. Evidence of extrauterine spread on medical imaging 11. Congenital or acquired uterine anomaly which distorts the uterine cavity 12. Acute pelvic inflammatory disease 13. Conditions associated with increased susceptibility to infections with microorganisms (e. g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History 14. Genital actinomycosis 15. Current other cancer, except low grade malignancies that do not require any systemic treatment or treatment to the pelvis 16. Breastfeeding mothers 17. Mirena inserted greater than 6 weeks before randomisation/enrolment 18. Previous use of Mirena within the last 5 years from randomisation/enrolment 19. Contraindications to both Metformin and weight loss

Locations and Contacts

Sara L Scalzo, Phone: +61 7 3646 2141, Email: sara.scalzo@health.qld.gov.au

Christchurch Women's Hospital, Christchurch, New Zealand; Recruiting
Peter Sykes, Principal Investigator
Bryony Simcock, Sub-Investigator

Chris O'Brien Lifehouse, Camperdown, New South Wales 2050, Australia; Not yet recruiting
Jonathan Carter, Principal Investigator
Selvan Pather, Sub-Investigator

John Hunter Hospital, New Lambton, New South Wales 2305, Australia; Not yet recruiting
Geoffrey Otton, Principal Investigator

The Wesley Hospital, Auchenflower, Queensland 4066, Australia; Recruiting
Jim Nicklin, Principal Investigator
Andrea Garrett, Sub-Investigator

Brisbane Private Hospital, Brisbane, Queensland 4000, Australia; Withdrawn

Royal Brisbane and Women's Hospital, Brisbane, Queensland 4029, Australia; Recruiting
Andreas Obermair, Principal Investigator
James Nicklin, Sub-Investigator
Russell Land, Sub-Investigator
Andrea Garrett, Sub-Investigator

Greenslopes Private Hospital, Greenslopes, Queensland 4120, Australia; Recruiting
Andreas Obermair, Principal Investigator
Russell Land, Sub-Investigator
Naven Chetty, Sub-Investigator

Mater Health Services, Brisbane, South Brisbane, Queensland 4101, Australia; Recruiting
Lewis Perrin, Principal Investigator
Naven Chetty, Sub-Investigator
Alex Crandon, Sub-Investigator

Mater Private Hospital, South Brisbane, Queensland 4101, Australia; Active, not recruiting

Gold Coast Hospital, Southport, Queensland 4215, Australia; Not yet recruiting
Marcelo Nascimento, Principal Investigator

Mater Misericordiae Hospital Townsville, Townsville, Queensland 4810, Australia; Recruiting
Andreas Obermair, Principal Investigator
James Nicklin, Sub-Investigator
Lewis Perrin, Sub-Investigator
Russell Land, Sub-Investigator
Andrea Garrett, Sub-Investigator
Naven Chetty, Sub-Investigator

John Flynn Hospital, Tugun, Queensland 4224, Australia; Not yet recruiting
Marcelo Nascimento, Principal Investigator
Alex Crandon, Sub-Investigator

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; Not yet recruiting
Martin Oehler, Principal Investigator

Queen Elizabeth Hospital, Woodville, South Australia 5011, Australia; Not yet recruiting
John Miller, Principal Investigator

Royal Women's Hospital, Carlton, Victoria 3053, Australia; Not yet recruiting
Orla McNally, Principal Investigator
Michael Quinn, Sub-Investigator
Deborah Neesham, Sub-Investigator
David Wrede, Sub-Investigator

King Edward Memorial Hospital for Women, Perth, Western Australia 6008, Australia; Not yet recruiting
Yee Leung, Principal Investigator
Stuart Salfinger, Sub-Investigator
Jason Tan, Sub-Investigator

St John of God Hospital, Subiaco, Western Australia 6904, Australia; Not yet recruiting
Stuart Salfinger, Principal Investigator
Jason Tan, Sub-Investigator

Additional Information

Starting date: October 2012
Last updated: December 14, 2014

Page last updated: August 23, 2015

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