Endometrial CancerPhase 3NCT00096408
Laparoscopic Approach to Cancer of the Endometrium
A Phase 3 study testing Total Abdominal Hysterectomy and Total Laparoscopic Hysterectomy in people with Endometrial Cancer, run by Queensland Centre for Gynaecological Cancer at 23 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Total Abdominal Hysterectomy and Total Laparoscopic Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 23 sitesin 4 countries
- Study dates
- Oct 2005to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
Australia19 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Wesley Hospital
Auchenflower, Queensland, 4066
Box Hill Hospital
Box Hill, Victoria, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Royal Women's Hospital
Carlton, Victoria, 3168
Monash Medical Centre
Clayton, Victoria, 3168
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Cabrini Health
Malvern, Victoria, 3144
John Hunter Hospital
New Lambton, New South Wales, 2305
Newcastle Private Hospital
New Lambton Heights, New South Wales, 2305
King Edward Memorial Hospital for Women
Perth, Western Australia, 6008
Royal Hospital for Women
Randwick, New South Wales, 2031
Mater Adult Public Hospital
South Brisbane, Queensland, 4101
Royal North Shore Hospital
St Leonards, New South Wales, 2065
St John of God Hospital
Subiaco, Western Australia, 6904
Mater Misericordiae Hospital Townsville
Townsville, Queensland, 4810
Townsville Hospital
Townsville, Queensland, 4810
Westmead Hospital
Westmead, New South Wales, 2050
New Zealand2 sites
Christchurch Women's Hospital
Christchurch, Canterbury
Oxford Clinic Women's Health
Christchurch
About this study
Official title: 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).
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Total Abdominal Hysterectomy, Total Laparoscopic Hysterectomy
- Keywords
- Endometrial, Endometrium, Uterus, Cancer, Carcinoma, Adenocarcinoma, Stage 1, Hysterectomy, Laparoscopy, Abdominal, Total, Surgery, Quality of Life, Disease-free survival
- Medical subject headings
- Endometrial Neoplasms, Neoplasms, Carcinoma, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Abdominal HysterectomyProcedure or surgery
Also called TAH, Open hysterectomy
For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.
Total Laparoscopic HysterectomyProcedure or surgery
Also called Keyhole 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Total Abdominal Hysterectomy Receives: Procedure: Total Abdominal Hysterectomy |
| 2 | Experimental | Total Laparoscopic Hysterectomy Receives: Procedure: Total Laparoscopic Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 4.5 years from surgery
Secondary outcomes (4)
Intra/Peri/Post-operative and long-term morbidity
Measured: 30 days from surgery
Patterns of recurrence
Measured: 4.5 years from surgery
Pain and analgesia
Measured: 1 week, 1 month, 3 months and 6 months postoperative.
Quality of Life
Measured: Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startOct 2005
- Primary completionApr 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- 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, Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council Western Australia, Cancer Australia
- Responsible party
- Sponsor
- Investigators
- Andreas Obermair, Principal investigator, Queensland Centre for Gynaecological Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096408
- Sponsor's protocol ID
- LACE001
- Status last verified
- Mar 2019
- First submitted
- 9 Nov 2004
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 16678497Gebski 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.
PubMed 35576502Janda 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.
PubMed 28350928Belavy 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.
PubMed 24007947Kondalsamy-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.
PubMed 22503396Janda 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.
PubMed 20638899
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT00096408
- Acronym / sponsor ID
- LACE001
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial, Endometrium, Uterus, Cancer, Carcinoma, Adenocarcinoma, Stage 1, Hysterectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- 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, Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council Western Australia, Cancer Australia
- Study start
- Oct 2005 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Total Abdominal HysterectomyTotal Abdominal Hysterectomy |
| 2 | Experimental | Procedure: Total Laparoscopic HysterectomyTotal Laparoscopic Hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Abdominal HysterectomyAlso: TAH, Open hysterectomyFor patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia. | Procedure or surgery | 1 |
| Total Laparoscopic HysterectomyAlso: Keyhole hysterectomyThe 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. | Procedure or surgery | 2 |
Primary outcome
Disease free survival
Time frame: 4.5 years from surgery
4 secondary outcomes
Intra/Peri/Post-operative and long-term morbidity
Time frame: 30 days from surgery
Patterns of recurrence
Time frame: 4.5 years from surgery
Pain and analgesia
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Background: PubMed 16678497Janda 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.
- Derived from this study: PubMed 35576502Gebski 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.
- Derived from this study: PubMed 28350928Janda 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.
- Derived from this study: PubMed 24007947Belavy 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.
- Derived from this study: PubMed 22503396Kondalsamy-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.
- Derived from this study: PubMed 20638899Janda 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.
- Gynaecological Oncology websiteLink provided by the sponsor.
- QCGC ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Obermair principal investigator
Queensland Centre for Gynaecological Cancer
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Total Abdominal Hysterectomy and Total Laparoscopic Hysterectomy in people with Endometrial Cancer, run by Queensland Centre for Gynaecological Cancer at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Australia, New Zealand, Hong Kong, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 4.5 years from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096408, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.