Study 18 of 529 for search of: Australia, Western Australia
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Laparoscopic Approach to Cancer of the Endometrium
This study is currently recruiting participants.
Verified by Queensland Centre for Gynaecological Cancer, October 2008
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
Information provided by: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00096408
  Purpose

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
Endometrial Cancer
 Procedure: Total Abdominal Hysterectomy
Procedure: Total Laparoscopic Hysterectomy
 Phase III

MedlinePlus related topics: Cancer Hysterectomy
U.S. FDA Resources
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

Further study details as provided by Queensland Centre for Gynaecological Cancer:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra/Peri/Post-operative and long-term morbidity [ Time Frame: 30 days from surgery ] [ Designated as safety issue: Yes ]
  • Patterns of recurrence [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]
  • Pain and analgesia [ Time Frame: 1 week, 1 month, 3 months and 6 months postoperative. ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. ] [ Designated as safety issue: No ]

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
1: Active Comparator
Total Abdominal Hysterectomy
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.
2: Experimental
Total Laparoscopic Hysterectomy
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096408

Contacts
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au

Locations
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            
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
Investigators
Principal Investigator: Andreas Obermair Queensland Centre for Gynaecological Cancer
  More Information

Gynaecological Oncology website  This link exits the ClinicalTrials.gov site
Gynaecological cancer Society (Non-profit)  This link exits the ClinicalTrials.gov site

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. Epub 2006 May 5.

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

Keywords provided by Queensland Centre for Gynaecological Cancer:
Endometrial
Endometrium
Uterus
Cancer
Carcinoma
Adenocarcinoma
Stage 1
 Hysterectomy
Laparoscopy
Abdominal
Total
Surgery
Quality of Life
Disease-free survival

Study placed in the following topic categories:
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Quality of Life
Uterine Diseases
 Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer
Adenocarcinoma
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009



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