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Laparoscopic Approach to Cancer of the Endometrium

CompletedPhase 3

Sponsor: Queensland Centre for Gynaecological Cancer

Conditions: Endometrial Cancer

Interventions: Total Abdominal Hysterectomy, Total Laparoscopic Hysterectomy

Countries: Australia, Hong Kong, New Zealand, United Kingdom

The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Patients who may be included for this study must have the following:

* Histologically confirmed primary endometrioid adenocarcinoma of the endometrium;
* Clinical stage I disease;
* ECOG Performance status of 0-1;
* Signed written informed consent;
* Females, aged 18 years or older.

Exclusion Criteria:

Patients will be excluded from participating from the study if they have any of the following:

* Other histologic type than endometrioid adenocarcinoma of the endometrium;
* Clinically advanced disease (stages II-IV);
* Uterine size larger than 10 weeks gestation;
* Estimated life expectancy of less than 6 months;
* Enlarged aortic lymph nodes;
* Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patient compliance and geographic proximity that does not allow adequate follow-up;
* Unfit to complete QoL measurements.

Locations (23)

Camperdown, New South Wales, Australia
New Lambton, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Randwick, New South Wales, Australia
St Leonards, New South Wales, Australia
Westmead, New South Wales, Australia
Auchenflower, Queensland, Australia
Greenslopes, Queensland, Australia
Herston, Queensland, Australia
South Brisbane, Queensland, Australia
Townsville, Queensland, Australia
Townsville, Queensland, Australia
Adelaide, South Australia, Australia
Box Hill, Victoria, Australia
Carlton, Victoria, Australia
Clayton, Victoria, Australia
Malvern, Victoria, Australia
Perth, Western Australia, Australia
Subiaco, Western Australia, Australia
Pok Fu Lam, Hong Kong
Christchurch, Canterbury, New Zealand
Christchurch, New Zealand
Edinburgh, United Kingdom