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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000261516

Acronym

LACE

Enrollment

755

Registered

2006-06-28

Start date

2005-10-01

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results