Spots Global Cancer Trial Database for Improving the Treatment for Women With Early Stage Cancer of the Uterus
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Trial Identification
Brief Title: Improving the Treatment for Women With Early Stage Cancer of the Uterus
Official Title: A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium
Study ID: NCT01686126
Study Description
Brief 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%).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
The Wesley Hospital, Auchenflower, Queensland, Australia
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
Greenslopes Private Hospital, Greenslopes, Queensland, Australia
Mater Health Services, Brisbane, South Brisbane, Queensland, Australia
Mater Private Hospital, South Brisbane, Queensland, Australia
Gold Coast Hospital, Southport, Queensland, Australia
Townsville Hospital, Townsville, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Royal Women's Hospital, Carlton, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
King Edward Memorial Hospital for Women, Perth, Western Australia, Australia
St John of God Hospital, Subiaco, Western Australia, Australia
Auckland City Hospital, Auckland, , New Zealand
Middlemore Hospital, Auckland, , New Zealand
Christchurch Women's Hospital, Christchurch, , New Zealand
Wellington Hospital, Wellington, , New Zealand
Contact Details
Name: Andreas Obermair
Affiliation: Queensland Centre for Gynaecological Cancer
Role: STUDY_CHAIR
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