Trial registered on ANZCTR


Trial ID
ACTRN12606000261516
Ethics application status
Approved
Date submitted
21/06/2006
Date registered
28/06/2006
Date last updated
4/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
LACE – Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
Scientific title
LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial. The primary objective is to assess disease free survival 4.5 years post-operatively.
Secondary ID [1] 271 0
ClinicalTrials.gov: NCT00096408
Universal Trial Number (UTN)
Trial acronym
LACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Adenocarcinoma - FIGO Stage 1 1237 0
Condition category
Condition code
Cancer 1322 1322 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total Abdominal Hysterectomy (TAH) + pelvic/aortic lymph node dissection.
Total Laparoscopic Hysterectomy (TLH) + laparoscopic pelvic/aortic lymph node dissection
Intervention code [1] 969 0
Treatment: surgery
Comparator / control treatment
Total Abdominal Hysterectomy (TAH) + pelvic aortic lymph node dissection.
Control group
Active

Outcomes
Primary outcome [1] 1807 0
Disease-free survival
Timepoint [1] 1807 0
4.5 years after surgery
Secondary outcome [1] 3167 0
Intra/Peri/Post-operative and long-term morbidity
Timepoint [1] 3167 0
12 months after surgery
Secondary outcome [2] 3168 0
Patterns of recurrence
Timepoint [2] 3168 0
4.5 years after surgery
Secondary outcome [3] 6402 0
Treatment Costs.
Timepoint [3] 6402 0
4 weeks to 12 months.
Secondary outcome [4] 6403 0
Quality of Life.
Timepoint [4] 6403 0
Preoperatively and 4.5 years postoperative.
Secondary outcome [5] 6404 0
Pelvic Floor Functioning.
Timepoint [5] 6404 0
Preoperatively and 4.5 years postoperative.
Secondary outcome [6] 6405 0
Survival.
Timepoint [6] 6405 0
At 4.5 years follow-up.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised permuted blocks will be used to allocate patients between the two treatment groups with an allocation ratio of 2:1, favouring the intervention of TLH (variable blocks sizes). Randomisations will be stratified according to treating centre and by grade of differentiation (as taken from the endometrial biopsy/D&C).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Anticipated
Actual
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA
Recruitment outside Australia
Country [1] 294 0
New Zealand
State/province [1] 294 0
Christchurch
Country [2] 295 0
Hong Kong
State/province [2] 295 0
Pokfulam
Country [3] 296 0
United Kingdom
State/province [3] 296 0
Edinburgh
Country [4] 297 0
United Kingdom
State/province [4] 297 0
Edinburgh

Funding & Sponsors
Funding source category [1] 1447 0
Charities/Societies/Foundations
Name [1] 1447 0
Qld Cancer Fund
Address [1] 1447 0
PO Box 201, Spring Hill Qld 4004
Country [1] 1447 0
Australia
Funding source category [2] 1448 0
Charities/Societies/Foundations
Name [2] 1448 0
Cancer Council (NSW, WA, VIC)
Address [2] 1448 0
153 Dowling Street
Woolloomooloo, NSW 2011
PO Box 572
Kings Cross NSW 1340
Australia
Country [2] 1448 0
Australia
Funding source category [3] 1449 0
Commercial sector/Industry
Name [3] 1449 0
Tyco
Address [3] 1449 0
2nd Floor, 90 Pitts Bay Road
Pembroke HM 08, Bermuda
United States
Country [3] 1449 0
Australia
Funding source category [4] 1450 0
Commercial sector/Industry
Name [4] 1450 0
Johnson & Johnson
Address [4] 1450 0
Not available
Country [4] 1450 0
United States of America
Funding source category [5] 1451 0
Commercial sector/Industry
Name [5] 1451 0
Genentech
Address [5] 1451 0
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
Country [5] 1451 0
United States of America
Funding source category [6] 2958 0
Government body
Name [6] 2958 0
NHMRC
Address [6] 2958 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [6] 2958 0
Australia
Funding source category [7] 2959 0
Government body
Name [7] 2959 0
QUEENSLAND HEALTH
Address [7] 2959 0
Queensland Health Building
147-163 Charlotte Street
Brisbane Queensland 4000
Country [7] 2959 0
Australia
Funding source category [8] 256571 0
Government body
Name [8] 256571 0
Cancer Australia
Address [8] 256571 0
PO Box 1201,
Dickson, Canberra ACT 2602
Country [8] 256571 0
Australia
Funding source category [9] 256581 0
Government body
Name [9] 256581 0
Cancer Australia
Address [9] 256581 0
PO Box 1201,
Dickson, Canberra ACT 2602
Country [9] 256581 0
Australia
Primary sponsor type
Government body
Name
Qld Centre for Gynaecological Cancer
Address
Level 6, Ned Hanlon Building
Royal Brisbane and Womens Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 1280 0
University
Name [1] 1280 0
University of Queensland
Address [1] 1280 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 1280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2820 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 2820 0
Herston, Qld
Ethics committee country [1] 2820 0
Australia
Date submitted for ethics approval [1] 2820 0
Approval date [1] 2820 0
20/09/2004
Ethics approval number [1] 2820 0
2004/025
Ethics committee name [2] 2821 0
Mater Health Services
Ethics committee address [2] 2821 0
South Brisbane Qld
Ethics committee country [2] 2821 0
Australia
Date submitted for ethics approval [2] 2821 0
Approval date [2] 2821 0
26/11/2004
Ethics approval number [2] 2821 0
777P
Ethics committee name [3] 2822 0
Greenslopes Private Hospital
Ethics committee address [3] 2822 0
Greenslopes Qld
Ethics committee country [3] 2822 0
Australia
Date submitted for ethics approval [3] 2822 0
Approval date [3] 2822 0
14/12/2004
Ethics approval number [3] 2822 0
04/12
Ethics committee name [4] 2823 0
Wesley Hospital
Ethics committee address [4] 2823 0
Auchenflower, Qld
Ethics committee country [4] 2823 0
Australia
Date submitted for ethics approval [4] 2823 0
Approval date [4] 2823 0
25/08/2005
Ethics approval number [4] 2823 0
2004/60
Ethics committee name [5] 2824 0
Monash Medical Centre
Ethics committee address [5] 2824 0
East Bentleigh, Vic
Ethics committee country [5] 2824 0
Australia
Date submitted for ethics approval [5] 2824 0
Approval date [5] 2824 0
18/11/2004
Ethics approval number [5] 2824 0
04144C
Ethics committee name [6] 2825 0
St John of God Hopsital
Ethics committee address [6] 2825 0
Subiaco WA
Ethics committee country [6] 2825 0
Australia
Date submitted for ethics approval [6] 2825 0
Approval date [6] 2825 0
02/06/2005
Ethics approval number [6] 2825 0
213
Ethics committee name [7] 2826 0
King Edward Memorial Hospital
Ethics committee address [7] 2826 0
Subiaco, WA
Ethics committee country [7] 2826 0
Australia
Date submitted for ethics approval [7] 2826 0
Approval date [7] 2826 0
05/07/2005
Ethics approval number [7] 2826 0
EC05-42.3
Ethics committee name [8] 2827 0
Westmead Hospital
Ethics committee address [8] 2827 0
Westmead, NSW
Ethics committee country [8] 2827 0
Australia
Date submitted for ethics approval [8] 2827 0
Approval date [8] 2827 0
30/03/2006
Ethics approval number [8] 2827 0
2006/12/4.27
Ethics committee name [9] 4899 0
The Townsville Health Service District Institutional Ethics Committee
Ethics committee address [9] 4899 0
PO Box 670 TOWNSVILLE QLD 4810
Ethics committee country [9] 4899 0
Australia
Date submitted for ethics approval [9] 4899 0
21/09/2006
Approval date [9] 4899 0
05/10/2006
Ethics approval number [9] 4899 0
55/06
Ethics committee name [10] 4900 0
Mater Misericordiae Hospital Townsville Research & Ethics Committee
Ethics committee address [10] 4900 0
Locked Bag 1000 TOWNSVILLE DC QLD 4810
Ethics committee country [10] 4900 0
Australia
Date submitted for ethics approval [10] 4900 0
23/05/2007
Approval date [10] 4900 0
17/07/2007
Ethics approval number [10] 4900 0
NA
Ethics committee name [11] 4901 0
The Royal Women's Hospital Human Ethics Committee
Ethics committee address [11] 4901 0
The Royal Women's Hospital 132 Grattan Street CARLTON VIC 3053
Ethics committee country [11] 4901 0
Australia
Date submitted for ethics approval [11] 4901 0
06/06/2006
Approval date [11] 4901 0
24/10/2006
Ethics approval number [11] 4901 0
06/30
Ethics committee name [12] 4902 0
Cabrini Hospital Human Research Ethics Committee
Ethics committee address [12] 4902 0
183 Wattletree Road MALVERN VIC 3144
Ethics committee country [12] 4902 0
Australia
Date submitted for ethics approval [12] 4902 0
01/08/2006
Approval date [12] 4902 0
21/08/2006
Ethics approval number [12] 4902 0
01-21-08-06
Ethics committee name [13] 4903 0
Hunter New England Human Research Ethics Committee
Ethics committee address [13] 4903 0
Locked Bag 1 Lookout Road NEW LAMBTON NSW 2305
Ethics committee country [13] 4903 0
Australia
Date submitted for ethics approval [13] 4903 0
23/03/2007
Approval date [13] 4903 0
03/04/2007
Ethics approval number [13] 4903 0
07/03/21/3.04
Ethics committee name [14] 4904 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [14] 4904 0
Royal Adelaide Hospital Research Ethics Committee Level 3, Hanson Institute North Terrace ADELAIDE SA 5000
Ethics committee country [14] 4904 0
Australia
Date submitted for ethics approval [14] 4904 0
06/03/2007
Approval date [14] 4904 0
04/05/2007
Ethics approval number [14] 4904 0
070413
Ethics committee name [15] 4905 0
Upper B South Regional Ethics Committee
Ethics committee address [15] 4905 0
Ministry of Health
4th Floor, 250 Oxford Terrace
PO Box 3877
Christchurch New Zealand
Ethics committee country [15] 4905 0
New Zealand
Date submitted for ethics approval [15] 4905 0
01/07/2006
Approval date [15] 4905 0
21/07/2006
Ethics approval number [15] 4905 0
URB/06/06/049
Ethics committee name [16] 4906 0
Institutional Review Board of the University of Hong Kong
Ethics committee address [16] 4906 0
Hong Kong West Cluster,
Queen Mary Hospital,
102 Pokfulam Road
Pokfulam Hong Kong
Ethics committee country [16] 4906 0
Hong Kong
Date submitted for ethics approval [16] 4906 0
01/02/2008
Approval date [16] 4906 0
Ethics approval number [16] 4906 0
New ethics HREC. Please modify.

Summary
Brief summary
Phase 3

This study compares standard abdominal surgery with laparoscopic (keyhole) surgery for women with early stage cancer of the endometrium (lining of the womb).

Who is it for?
You can join this study if you have early stage cancer of the endometrium (lining of the womb) that has not spread beyond the wall of the womb. This is determined by scans before the operation.

Trial details
Participants will be randomly divided into two groups. One group receives standard abdominal surgery and the other receives laparoscopic (keyhole) surgery for removing the uterus (womb). Women will have an equal chance of being offered one or other surgical approaches and will be followed for up to 4 ½ years to trace any women whose cancers return.

Normally, surgery is carried out through a cut just above the pelvic bone, and the womb is removed together with ovaries and fallopian tubes. Lymph nodes may also have to be removed. For almost all women, this is curative surgery.

This new technique may reduce some of the problems that people may experience immediately after surgery and in the longer term. The study is seeking to understand whether the same excellent outcomes can be achieved with surgery that is usually better tolerated.
Trial website
delete web site, no longer valid
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35329 0
Address 35329 0
Country 35329 0
Phone 35329 0
Fax 35329 0
Email 35329 0
Contact person for public queries
Name 10158 0
Ms Trudi Cattley
Address 10158 0
QCGC
Teaching and Research Level 6
Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Qld 4026
Country 10158 0
Australia
Phone 10158 0
+61 7 3636 0447
Fax 10158 0
+61 7 3636 1721
Email 10158 0
trudi_cattley@helath.qld.gov.au
Contact person for scientific queries
Name 1086 0
Professor Andreas Obermair
Address 1086 0
QCGC
Teaching and Research Level 6
Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Qld 4026
Country 1086 0
Australia
Phone 1086 0
+61 7 3636 5485
Fax 1086 0
+61 7 3636 2307
Email 1086 0
andreas_obermair@health.qld.gov.au