RecruitingPhase 3ACTRN12606000261516

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.


Sponsor

Qld Centre for Gynaecological Cancer

Enrollment

755 participants

Start Date

Oct 1, 2005

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing standard abdominal surgery with laparoscopic (keyhole) surgery for women with early-stage cancer of the endometrium (the lining of the womb). Both types of surgery remove the womb, ovaries, and fallopian tubes. Keyhole surgery may be better tolerated and lead to faster recovery. The trial aims to find out whether cancer outcomes are just as good with keyhole surgery. You may be eligible if: - You are a woman aged 18 or older - You have been confirmed to have endometrial cancer (endometrioid type) confined to the womb (Stage I) - Your general health is good (ECOG performance status 0–1) - You have given written informed consent You may NOT be eligible if: - You have a different type of womb cancer (not endometrioid adenocarcinoma) - Your cancer has spread beyond the womb (Stage II–IV) - Your uterus is larger than a 10-week pregnancy size - Your life expectancy is less than 6 months - You have significantly enlarged lymph nodes around the major vessels - You are not fit for surgery - You are unable to attend follow-up appointments or complete quality-of-life questionnaires Talk to your doctor about whether this trial might be right for you.

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

Total Abdominal Hysterectomy (TAH) + pelvic/aortic lymph node dissection. Total Laparoscopic Hysterectomy (TLH) + laparoscopic pelvic/aortic lymph node dissection


Locations(4)

Christchurch, New Zealand

Pokfulam, Hong Kong

Edinburgh, United Kingdom

Edinburgh, United Kingdom

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ACTRN12606000261516