Laparoscopic Approach to Cancer of the Endometrium

Queensland Centre for Gynaecological Cancer

Status and phase

Completed

Phase 3

Conditions

Endometrial Cancer

Treatments

Procedure: Total Laparoscopic Hysterectomy

Procedure: Total Abdominal Hysterectomy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00096408

LACE001

Details and patient eligibility

About

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).

Full 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.

Enrollment

760 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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.