Laparoscopic Approach to Cancer of the Endometrium

March 18, 2019 updated by: Queensland Centre for Gynaecological Cancer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

760

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital
      • New Lambton Heights, New South Wales, Australia, 2305
        • Newcastle Private Hospital
      • Randwick, New South Wales, Australia, 2031
        • Royal Hospital for Women
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia, 2050
        • Westmead Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • The Wesley Hospital
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Public Hospital
      • Townsville, Queensland, Australia, 4810
        • Mater Misericordiae Hospital Townsville
      • Townsville, Queensland, Australia, 4810
        • Townsville Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Carlton, Victoria, Australia, 3168
        • Royal Women's Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Malvern, Victoria, Australia, 3144
        • Cabrini Health
    • Western Australia
      • Perth, Western Australia, Australia, 6008
        • King Edward Memorial Hospital for Women
      • Subiaco, Western Australia, Australia, 6904
        • St John of God Hospital
  • Hong Kong
      • Pok Fu Lam, Hong Kong
        • Queen Mary Hospital
  • New Zealand
      • Christchurch, New Zealand
        • Oxford Clinic Women's Health
    • Canterbury
      • Christchurch, Canterbury, New Zealand
        • Christchurch Women's Hospital
  • United Kingdom
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Total Abdominal Hysterectomy
Procedure: Total 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.
Other Names:
  • TAH
  • Open hysterectomy
Experimental: 2
Total Laparoscopic Hysterectomy
Procedure: Total 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.
Other Names:
  • Keyhole hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: 4.5 years from surgery
4.5 years from surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queensland Centre for Gynaecological Cancer

Collaborators

National Health and Medical Research Council, Australia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tyco Healthcare Group
Gynetech
Queensland Government - Smart Health Research Grant
Cancer Council Queensland
Cancer Council New South Wales
Cancer Council Victoria
Cancer Council Western Australia
Cancer Australia

Investigators

  • Principal Investigator: Andreas Obermair, Queensland Centre for Gynaecological Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2005

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (Estimate)

November 9, 2004

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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