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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00096408




Registration number
NCT00096408
Ethics application status
Date submitted
9/11/2004
Date registered
9/11/2004
Date last updated
20/03/2019

Titles & IDs
Public title
Laparoscopic Approach to Cancer of the Endometrium
Scientific title
LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
Secondary ID [1] 0 0
LACE001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Total Abdominal Hysterectomy
Treatment: Surgery - Total Laparoscopic Hysterectomy

Active comparator: 1 - Total Abdominal Hysterectomy

Experimental: 2 - Total Laparoscopic Hysterectomy


Treatment: Surgery: 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.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease free survival
Timepoint [1] 0 0
4.5 years from surgery
Secondary outcome [1] 0 0
Intra/Peri/Post-operative and long-term morbidity
Timepoint [1] 0 0
30 days from surgery
Secondary outcome [2] 0 0
Patterns of recurrence
Timepoint [2] 0 0
4.5 years from surgery
Secondary outcome [3] 0 0
Pain and analgesia
Timepoint [3] 0 0
1 week, 1 month, 3 months and 6 months postoperative.
Secondary outcome [4] 0 0
Quality of Life
Timepoint [4] 0 0
Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.

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;
* Females, aged 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Sex
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
760
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 0 0
Royal Hospital for Women - Randwick
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [8] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [9] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [10] 0 0
Mater Adult Public Hospital - South Brisbane
Recruitment hospital [11] 0 0
Mater Misericordiae Hospital Townsville - Townsville
Recruitment hospital [12] 0 0
Townsville Hospital - Townsville
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [15] 0 0
Royal Women's Hospital - Carlton
Recruitment hospital [16] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [17] 0 0
Cabrini Health - Malvern
Recruitment hospital [18] 0 0
King Edward Memorial Hospital for Women - Perth
Recruitment hospital [19] 0 0
St John of God Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
2050 - Westmead
Recruitment postcode(s) [7] 0 0
4066 - Auchenflower
Recruitment postcode(s) [8] 0 0
4120 - Greenslopes
Recruitment postcode(s) [9] 0 0
4029 - Herston
Recruitment postcode(s) [10] 0 0
4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
4810 - Townsville
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3168 - Carlton
Recruitment postcode(s) [15] 0 0
3168 - Clayton
Recruitment postcode(s) [16] 0 0
3144 - Malvern
Recruitment postcode(s) [17] 0 0
6008 - Perth
Recruitment postcode(s) [18] 0 0
6904 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Pok Fu Lam
Country [2] 0 0
New Zealand
State/province [2] 0 0
Canterbury
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Tyco Healthcare Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Gynetech
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Queensland Government - Smart Health Research Grant
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
National Health and Medical Research Council, Australia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Cancer Council Queensland
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Cancer Council New South Wales
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Cancer Council Victoria
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Cancer Council Western Australia
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Cancer Australia
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00096408
Trial related presentations / publications
Janda M, Gebski V, Forder P, Jackson D, Williams G, Obermair A; LACE Trial Committee. Total laparoscopic versus open surgery for stage 1 endometrial cancer: the LACE randomized controlled trial. Contemp Clin Trials. 2006 Aug;27(4):353-63. doi: 10.1016/j.cct.2006.03.004. Epub 2006 May 5.
Gebski V, Obermair A, Janda M. Toward Incorporating Health-Related Quality of Life as Coprimary End Points in Clinical Trials: Time to Achieve Clinical Important Differences and QoL Profiles. J Clin Oncol. 2022 Jul 20;40(21):2378-2388. doi: 10.1200/JCO.21.02750. Epub 2022 May 16.
Janda M, Gebski V, Davies LC, Forder P, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede CD, Pather S, Simcock B, Farrell R, Robertson G, Walker G, Armfield NR, Graves N, McCartney AJ, Obermair A. Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial. JAMA. 2017 Mar 28;317(12):1224-1233. doi: 10.1001/jama.2017.2068.
Belavy D, Janda M, Baker J, Obermair A. Epidural analgesia is associated with an increased incidence of postoperative complications in patients requiring an abdominal hysterectomy for early stage endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):423-9. doi: 10.1016/j.ygyno.2013.08.027. Epub 2013 Sep 3.
Kondalsamy-Chennakesavan S, Janda M, Gebski V, Baker J, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede DH, Pather S, Simcock B, Farrell R, Robertson G, Walker G, McCartney A, Obermair A. Risk factors to predict the incidence of surgical adverse events following open or laparoscopic surgery for apparent early stage endometrial cancer: results from a randomised controlled trial. Eur J Cancer. 2012 Sep;48(14):2155-62. doi: 10.1016/j.ejca.2012.03.013. Epub 2012 Apr 12.
Janda M, Gebski V, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, McCartney A, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Walsh T, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede CD, Pather S, Simcock B, Farrell R, Obermair A. Quality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): a randomised trial. Lancet Oncol. 2010 Aug;11(8):772-80. doi: 10.1016/S1470-2045(10)70145-5. Epub 2010 Jul 16.
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair
Address 0 0
Queensland Centre for Gynaecological Cancer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00096408