Spots Global Cancer Trial Database for Laparoscopic Approach to Cancer of the Endometrium
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Trial Identification
Brief Title: Laparoscopic Approach to Cancer of the Endometrium
Official Title: LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
Study ID: NCT00096408
Conditions
Study Description
Brief Summary: 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).
Detailed Description: This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer. The secondary hypotheses are: * TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months; * TLH is associated with reduced treatment-related morbidity; * TLH is associated with shorter hospital stay; * TLH is associated with less analgesic consumption; * TLH is cost effective; * TLH is associated with improved pelvic floor function.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Newcastle Private Hospital, New Lambton Heights, New South Wales, Australia
John Hunter Hospital, New Lambton, New South Wales, Australia
Royal Hospital for Women, Randwick, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
The Wesley Hospital, Auchenflower, Queensland, Australia
Greenslopes Private Hospital, Greenslopes, Queensland, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Mater Adult Public Hospital, South Brisbane, Queensland, Australia
Mater Misericordiae Hospital Townsville, Townsville, Queensland, Australia
Townsville Hospital, Townsville, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Royal Women's Hospital, Carlton, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Cabrini Health, Malvern, Victoria, Australia
King Edward Memorial Hospital for Women, Perth, Western Australia, Australia
St John of God Hospital, Subiaco, Western Australia, Australia
Queen Mary Hospital, Pok Fu Lam, , Hong Kong
Christchurch Women's Hospital, Christchurch, Canterbury, New Zealand
Oxford Clinic Women's Health, Christchurch, , New Zealand
Royal Infirmary of Edinburgh, Edinburgh, , United Kingdom
Contact Details
Name: Andreas Obermair
Affiliation: Queensland Centre for Gynaecological Cancer
Role: PRINCIPAL_INVESTIGATOR
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