NCT00096408

Laparoscopic Approach to Cancer of the Endometrium

LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (actual)
• Sponsor: Queensland Centre for Gynaecological Cancer · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	Total Abdominal Hysterectomy	For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.
PROCEDURE	Total Laparoscopic Hysterectomy	The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.

Timeline

• Start date: 2005-10-01
• Primary completion: 2016-04-01
• Completion: 2018-12-01
• First posted: 2004-11-09
• Last updated: 2019-03-20

Locations

23 sites across 4 countries: Australia, Hong Kong, New Zealand, United Kingdom