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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00096408

Enrollment

760

Registered

2004-11-09

Start date

2005-10-31

Completion date

2018-12-31

Last updated

2019-03-20

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

Conditions

Endometrial Cancer

Keywords

Endometrial, Endometrium, Uterus, Cancer, Carcinoma, Adenocarcinoma, Stage 1, Hysterectomy, Laparoscopy, Abdominal, Total, Surgery, Quality of Life, Disease-free survival

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.

Interventions

PROCEDURETotal 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.

PROCEDURETotal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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; * Females, aged 18 years or older.

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.

Design outcomes

Primary

Measure	Time frame
Disease free survival	4.5 years from surgery

Secondary

Measure	Time frame
Intra/Peri/Post-operative and long-term morbidity	30 days from surgery
Patterns of recurrence	4.5 years from surgery
Pain and analgesia	1 week, 1 month, 3 months and 6 months postoperative.
Quality of Life	Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.

Countries

Australia, Hong Kong, New Zealand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026