Laparoscopic Approach to Cancer of the Endometrium

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tyco Healthcare Group
Gynetech
Queensland Government - Smart Health Research Grant
National Health and Medical Research Council, Australia
Queensland Cancer Fund
Cancer Council New South Wales
Cancer Council Victoria
Cancer Council Western Australia
Cancer Australia
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00096408
First received: November 9, 2004
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Endometrial Cancer
Procedure: Total Abdominal Hysterectomy
Procedure: Total Laparoscopic Hysterectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial

Resource links provided by NLM:


Further study details as provided by Queensland Centre for Gynaecological Cancer:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra/Peri/Post-operative and long-term morbidity [ Time Frame: 30 days from surgery ] [ Designated as safety issue: Yes ]
  • Patterns of recurrence [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]
  • Pain and analgesia [ Time Frame: 1 week, 1 month, 3 months and 6 months postoperative. ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: October 2005
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Keyhole hysterectomy

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096408

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia, 2305
Royal Hospital for Women
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia, 2050
Australia, Queensland
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Adult Public Hospital
South Brisbane, Queensland, Australia, 4101
Townsville Hospital
Townsville, Queensland, Australia, 4810
Mater Misericordiae Hospital Townsville
Townsville, Queensland, Australia, 4810
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Royal Women's Hospital
Carlton, Victoria, Australia, 3168
Monash Medical Centre
East Bentleigh, Victoria, Australia, 3204
Cabrini Health
Malvern, Victoria, Australia, 3144
Australia, Western Australia
King Edward Memorial Hospital for Women
Perth, Western Australia, Australia, 6008
St John of God Hospital
Subiaco, Western Australia, Australia, 6904
Hong Kong
Queen Mary Hospital
Pokfulam, Hong Kong
New Zealand
Christchurch Women's Hospital
Christchurch, Canterbury, New Zealand
Oxford Clinic Women's Health
Christchurch, New Zealand
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tyco Healthcare Group
Gynetech
Queensland Government - Smart Health Research Grant
National Health and Medical Research Council, Australia
Queensland Cancer Fund
Cancer Council New South Wales
Cancer Council Victoria
Cancer Council Western Australia
Cancer Australia
Investigators
Principal Investigator: Andreas Obermair Queensland Centre for Gynaecological Cancer
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00096408     History of Changes
Other Study ID Numbers: LACE001
Study First Received: November 9, 2004
Last Updated: June 10, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Queensland Centre for Gynaecological Cancer:
Hysterectomy
Endometrial
Endometrium
Uterus
Cancer
Carcinoma
Adenocarcinoma
Stage 1
Laparoscopy
Abdominal
Total
Surgery
Quality of Life
Disease-free survival

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014