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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 |
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Information provided by: | Queensland Centre for Gynaecological Cancer |
ClinicalTrials.gov Identifier: | NCT00096408 |
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 |
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Endometrial Cancer |
Procedure: Total Abdominal Hysterectomy Procedure: Total Laparoscopic Hysterectomy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial |
Estimated Enrollment: | 640 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Total Abdominal Hysterectomy
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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.
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2: Experimental
Total Laparoscopic Hysterectomy
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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.
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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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who may be included for this study must have the following:
Exclusion Criteria:
Patients will be excluded from participating from the study if they have any of the following:
Contact: Trudi Cattley, BAppSc | +61 7 3636 0447 | Trudi_Cattley@health.qld.gov.au |
Australia, New South Wales | |
Westmead Hospital | Recruiting |
Westmead, New South Wales, Australia, 2050 | |
Contact: Hogg Russell, FRANZCOG CGO +61 2 9845 8853 ext 2145 Russell_Hogg@wsahs.nsw.gov.au | |
Contact: Annie Stenlake, BHSM, RN +61 2 9845 6801 annieas@westgate.wh.usyd.edu.au | |
Principal Investigator: Russell Hogg | |
Royal Hospital for Women | Not yet recruiting |
Randwick, New South Wales, Australia, 2031 | |
Contact: Rhonda Farrell +61 2 9588 2356 rhondafarrell@mac.com | |
Contact: Ellen Barlow Ellen.Barlow@SESIAHS.HEALTH.NSW.GOV.AU | |
Principal Investigator: Rhonda Farrell | |
John Hunter Hospital | Recruiting |
New Lambton, New South Wales, Australia, 2305 | |
Contact: Geoffrey Otton, MBBS RANZCOG MRANZCOG CGO +61 2 4952 1037 | |
Contact: Jennifer Rutherford +61 2 4921 4007 Jenny.Rutherford@hnehealth.nsw.gov.au | |
Principal Investigator: Geoffrey Otton, MBBS RANZCOG MRANZCOG CGO | |
Newcastle Private Hospital | Recruiting |
New Lambton Heights, New South Wales, Australia, 2305 | |
Contact: Geoffrey Otton +61 2 4952 1037 | |
Contact: Jennifer Rutherford +61 2 4921 4007 Jenny.Rutherford@hnehealth.nsw.gov.au | |
Principal Investigator: Geoffery Otton, MBBS CGO RANZCOG MRANZCOG | |
Royal Prince Alfred Hospital | Not yet recruiting |
Camperdown, New South Wales, Australia, 2050 | |
Contact: Selvan Pather, FRANZCOG CGO 02 9515 6111 selvan.pather@email.cs.nsw.gov.au | |
Contact: Pinky Patel, FRANZCOG CGO 02 9515 6591 Pinky.Patel@sswahs.nsw.gov.au | |
Principal Investigator: Selvan Pather, FRANZCOG CGO | |
Sub-Investigator: Jonathan Carter | |
Royal North Shore Hospital | Not yet recruiting |
St Leonards, New South Wales, Australia, 2065 | |
Contact: Sue Valmadre sue.valmadre@bigpond.com | |
Contact: Bronwyn Raymond 02 9926 5050 braymond@nsccahs.health.nsw.gov.au | |
Principal Investigator: Sue Valmadre | |
Australia, Queensland | |
Royal Brisbane and Women's Hospital | Recruiting |
Herston, Queensland, Australia, 4029 | |
Contact: Andreas Obermair, FRANZCOG CGO +61 7 3636 8501 ext 68501 andreas_obermair@health.qld.gov.au | |
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Andreas Obermair, FRANZCOG CGO | |
Sub-Investigator: James Nicklin, FANZCOG CGO | |
Sub-Investigator: Russell Land, FRANZCOG CGO | |
Mater Adult Public Hospital | Recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Contact: Lewis Perrin, FRANZCOG CGO +61 7 3844 9932 lewisperrin@mc.mater.org.au | |
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Lewis Perrin, FRANZCOG CGO | |
Sub-Investigator: Marcelo Nascimento, FRANZCOG CGO | |
Townsville Hospital | Recruiting |
Townsville, Queensland, Australia, 4810 | |
Contact: Andreas Obermair, FRANZCOG CGO +61 7 3636 8501 Andreas_Obermair@health.qld.gov.au | |
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Andreas Obermair, FRANZCOG CGO | |
Sub-Investigator: Russell Land, FRANZCOG CGO | |
Sub-Investigator: James Nicklin, FRANZCOG CGO | |
Sub-Investigator: Lewis Perrin, FRANZCOG CGO | |
The Wesley Hospital | Recruiting |
Auchenflower, Queensland, Australia, 4066 | |
Contact: Jim Nicklin, Doctor +61 7 3871 2290 jnicklin@wesley.com.au | |
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Jim Nicklin, FANZCOG CGO | |
Greenslopes Private Hospital | Recruiting |
Greenslopes, Queensland, Australia, 4120 | |
Contact: Andreas Obermair +61 7 3847 3033 sue@obermair.info | |
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Andreas Obermair, FRANZCOG CGO | |
Sub-Investigator: Russell Land, FRANZCOG CGO | |
Mater Misericordiae Hospital Townsville | Recruiting |
Townsville, Queensland, Australia, 4810 | |
Contact: Andreas Obermair +61 7 3636 5485 andreas_obermair@health.qld.gov.au | |
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Andreas Obermair | |
Sub-Investigator: James Nicklin | |
Sub-Investigator: Lewis Perrin | |
Sub-Investigator: Russell Land | |
Australia, South Australia | |
Royal Adelaide Hospital | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Martin Oehler +61 8 8222 4816 martin.oehler@adelaide.edu.au | |
Contact: Joanne White +61 8 8222 2610 JWhite4@mail.rah.sa.gov.au | |
Principal Investigator: Martin Oehler, MD PhD FRANZCOG | |
Australia, Victoria | |
Monash Medical Centre | Recruiting |
East Bentleigh, Victoria, Australia, 3204 | |
Contact: Tom Manolitsas, FRANZCOG CGO +61 3 9594 5387 | |
Contact: Nicole Fairweather +61 3 9594 7917 Nicole.Fairweather@princehenrys.org | |
Principal Investigator: Tom Manolitsas, FRANZCOG CGO | |
Sub-Investigator: Tom Jobling, FRANZCOG CGO | |
Royal Women's Hospital | Recruiting |
Carlton, Victoria, Australia, 3168 | |
Contact: Deborah Neesham +61 39344 2658 deborah.neesham@affinityhealth.com | |
Contact: Margot Osinski (613) 8345 3547 margot.osinski@thewomens.org.au | |
Principal Investigator: Deborah Neesham, MBBS DCH MRACOG FRACOG | |
Cabrini Health | Terminated |
Malvern, Victoria, Australia, 3144 | |
Australia, Western Australia | |
King Edward Memorial Hospital for Women | Recruiting |
Perth, Western Australia, Australia, 6008 | |
Contact: Yee Leung, FRANZCOG CGO 08 9366 1669 Yee.Leung@health.wa.gov.au | |
Contact: Cherry Young 08 9340 1182 cyoung@obsgyn.uwa.edu.au | |
Sub-Investigator: Ian Hammond, FRCOG, CGO, MRCOG | |
Principal Investigator: Yee Leung, MBBS, RACOG, FRACOG, CGO | |
Sub-Investigator: Tom Walsh | |
Sub-Investigator: Stuart Salfinger | |
St John of God Hospital | Active, not recruiting |
Subiaco, Western Australia, Australia, 6904 | |
Hong Kong | |
Queen Mary Hospital | Recruiting |
Pokufulam, Hong Kong | |
Contact: Hextan Ngan, MBBS, MD, FRCOG hysngan@hkucc.hku.hk | |
Contact: Anne Wang | |
Principal Investigator: Hextan Ngan | |
New Zealand, Canterbury | |
Christchurch Women's Hospital | Recruiting |
Christchurch, Canterbury, New Zealand | |
Contact: Peter Sykes peter.sykes@chmeds.ac.nz | |
Contact: Dianne Harker, MA RN 03 364 4624 dianne.harker@otago.ac.nz | |
Principal Investigator: Peter Sykes | |
Sub-Investigator: Mike Laney |
Principal Investigator: | Andreas Obermair | Queensland Centre for Gynaecological Cancer |
Responsible Party: | Queensland Centre for Gynaecological Cancer ( Professor Andreas Obermair ) |
Study ID Numbers: | LACE001 |
Study First Received: | November 9, 2004 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00096408 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Endometrial Endometrium Uterus Cancer Carcinoma Adenocarcinoma Stage 1 |
Hysterectomy Laparoscopy Abdominal Total Surgery Quality of Life Disease-free survival |
Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Quality of Life Uterine Diseases |
Uterine Neoplasms Urogenital Neoplasms Endometrial cancer Adenocarcinoma Carcinoma |
Neoplasms Neoplasms by Site |