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

Phase 3
18 Years
Open (Enrolling)
Endometrial Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

4.5 years from surgery

Safety Issue:


Principal Investigator

Andreas Obermair

Investigator Role:

Principal Investigator

Investigator Affiliation:

Queensland Centre for Gynaecological Cancer


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

October 2005

Completion Date:

June 2014

Related Keywords:

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