Back to resultsLaparoscopic Approach to Cancer of the Endometrium
Primary Purpose
Endometrial Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Total Abdominal Hysterectomy
Total Laparoscopic Hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial, Endometrium, Uterus, Cancer, Carcinoma, Adenocarcinoma, Stage 1, Hysterectomy, Laparoscopy, Abdominal, Total, Surgery, Quality of Life, Disease-free survival
Eligibility 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.
Sites / Locations
- Royal Prince Alfred Hospital
- Newcastle Private Hospital
- John Hunter Hospital
- Royal Hospital for Women
- Royal North Shore Hospital
- Westmead Hospital
- The Wesley Hospital
- Greenslopes Private Hospital
- Royal Brisbane and Women's Hospital
- Mater Adult Public Hospital
- Mater Misericordiae Hospital Townsville
- Townsville Hospital
- Royal Adelaide Hospital
- Box Hill Hospital
- Royal Women's Hospital
- Monash Medical Centre
- Cabrini Health
- King Edward Memorial Hospital for Women
- St John of God Hospital
- Queen Mary Hospital
- Christchurch Women's Hospital
- Oxford Clinic Women's Health
- Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Total Abdominal Hysterectomy
Total Laparoscopic Hysterectomy
Outcomes
Primary Outcome Measures
Disease free survival
Secondary Outcome Measures
Intra/Peri/Post-operative and long-term morbidity
Patterns of recurrence
Pain and analgesia
Quality of Life
Full Information
NCT ID
NCT00096408
First Posted
November 9, 2004
Last Updated
March 18, 2019
Sponsor
Queensland Centre for Gynaecological Cancer
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
1. Study Identification
Unique Protocol Identification Number
NCT00096408
Brief Title
Laparoscopic Approach to Cancer of the Endometrium
Official Title
LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queensland Centre for Gynaecological Cancer
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial, Endometrium, Uterus, Cancer, Carcinoma, Adenocarcinoma, Stage 1, Hysterectomy, Laparoscopy, Abdominal, Total, Surgery, Quality of Life, Disease-free survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
760 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Total Abdominal Hysterectomy
Arm Title
2
Arm Type
Experimental
Arm Description
Total Laparoscopic Hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Total Abdominal Hysterectomy
Other Intervention Name(s)
TAH, Open hysterectomy
Intervention Description
For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.
Intervention Type
Procedure
Intervention Name(s)
Total Laparoscopic Hysterectomy
Other Intervention Name(s)
Keyhole hysterectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
4.5 years from surgery
Secondary Outcome Measure Information:
Title
Intra/Peri/Post-operative and long-term morbidity
Time Frame
30 days from surgery
Title
Patterns of recurrence
Time Frame
4.5 years from surgery
Title
Pain and analgesia
Time Frame
1 week, 1 month, 3 months and 6 months postoperative.
Title
Quality of Life
Time Frame
Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Obermair
Organizational Affiliation
Queensland Centre for Gynaecological Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Newcastle Private Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Royal Hospital for Women
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
The Wesley Hospital
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Adult Public Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Mater Misericordiae Hospital Townsville
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4810
Country
Australia
Facility Name
Townsville Hospital
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4810
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Royal Women's Hospital
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Cabrini Health
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
King Edward Memorial Hospital for Women
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
St John of God Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6904
Country
Australia
Facility Name
Queen Mary Hospital
City
Pok Fu Lam
Country
Hong Kong
Facility Name
Christchurch Women's Hospital
City
Christchurch
State/Province
Canterbury
Country
New Zealand
Facility Name
Oxford Clinic Women's Health
City
Christchurch
Country
New Zealand
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16678497
Citation
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.
Results Reference
background
PubMed Identifier
35576502
Citation
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.
Results Reference
derived
PubMed Identifier
28350928
Citation
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.
Results Reference
derived
PubMed Identifier
24007947
Citation
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.
Results Reference
derived
PubMed Identifier
22503396
Citation
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.
Results Reference
derived
PubMed Identifier
20638899
Citation
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.
Results Reference
derived
Links:
URL
http://www.obermair.info
Description
Gynaecological Oncology website
URL
http://www.gyncan.org/
Description
QCGC Research
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Laparoscopic Approach to Cancer of the Endometrium
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