Laparoscopic Approach to Cancer of the Endometrium

LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial

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).

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.

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.