LACE – Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial. The primary objective is to assess disease free survival 4.5 years post-operatively.
Qld Centre for Gynaecological Cancer
755 participants
Oct 1, 2005
Interventional
Conditions
Summary
Phase 3 This study compares standard abdominal surgery with laparoscopic (keyhole) surgery for women with early stage cancer of the endometrium (lining of the womb). Who is it for? You can join this study if you have early stage cancer of the endometrium (lining of the womb) that has not spread beyond the wall of the womb. This is determined by scans before the operation. Trial details Participants will be randomly divided into two groups. One group receives standard abdominal surgery and the other receives laparoscopic (keyhole) surgery for removing the uterus (womb). Women will have an equal chance of being offered one or other surgical approaches and will be followed for up to 4 ½ years to trace any women whose cancers return. Normally, surgery is carried out through a cut just above the pelvic bone, and the womb is removed together with ovaries and fallopian tubes. Lymph nodes may also have to be removed. For almost all women, this is curative surgery. This new technique may reduce some of the problems that people may experience immediately after surgery and in the longer term. The study is seeking to understand whether the same excellent outcomes can be achieved with surgery that is usually better tolerated.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Total Abdominal Hysterectomy (TAH) + pelvic/aortic lymph node dissection. Total Laparoscopic Hysterectomy (TLH) + laparoscopic pelvic/aortic lymph node dissection
Locations(4)
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ACTRN12606000261516