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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Active	18 and over	Other	LACE001 NCT00096408

Trial Description

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).

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Royal Brisbane and Women's Hospital

Andreas Obermair

Principal Investigator

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

Australia
	Perth
	King Edward Memorial Hospital for Women
		Yee Leung, FRANZCOG CGO	Ph: 08 9366 1669
			Email: Yee.Leung@health.wa.gov.au
		Cherry Young	Ph: 08 9340 1182
			Email: cyoung@obsgyn.uwa.edu.au
		Ian Hammond, FRCOG, CGO, MRCOG	Sub-Investigator
		Yee Leung, MBBS, RACOG, FRACOG, CGO	Principal Investigator
		Tom Walsh	Sub-Investigator
		Stuart Salfinger	Sub-Investigator
	Subiaco
	Saint John of God Hospital, Subiaco
		Tony McCartney	Ph: +61 8 9346 4606
			Email: mccartneyoffice@bigpond.com
		Joanne Youd	Ph: +61 8 9382 9410
			Email: Joanne.Youd@sjog.org.au
		Tony McCartney, FRANZCOG CGO	Principal Investigator
		Ian Hammond, FRCOG CGO FRACOG MRCOG	Sub-Investigator
New South Wales
	Camperdown
	Sydney Cancer Centre at Royal Prince Alfred Hospital
		Selvan Pather, FRANZCOG CGO	Ph: 02 9515 6111
			Email: selvan.pather@email.cs.nsw.gov.au
		Pinky Patel, FRANZCOG CGO	Ph: 02 9515 6591
			Email: Pinky.Patel@sswahs.nsw.gov.au
		Selvan Pather, FRANZCOG CGO	Principal Investigator
		Jonathan Carter	Sub-Investigator
	New Lambton
	John Hunter Hospital
		Geoffrey Otton, MBBS RANZCOG MRANZCOG CGO	Ph: +61 2 4952 1037
		Jennifer Rutherford	Ph: +61 2 4921 4007
			Email: Jenny.Rutherford@hnehealth.nsw.gov.au
		Geoffrey Otton, MBBS RANZCOG MRANZCOG CGO	Principal Investigator
	New Lambton Heights
	Newcastle Private Hospital
		Geoffrey Otton	Ph: +61 2 4952 1037
		Jennifer Rutherford	Ph: +61 2 4921 4007
			Email: Jenny.Rutherford@hnehealth.nsw.gov.au
		Geoffery Otton, MBBS CGO RANZCOG MRANZCOG	Principal Investigator
	St Leonards
	Royal North Shore Hospital
		Sue Valmadre
			Email: sue.valmadre@bigpond.com
		Bronwyn Raymond	Ph: 02 9926 5050
			Email: braymond@nsccahs.health.nsw.gov.au
		Sue Valmadre	Principal Investigator
	Westmead
	Westmead Institute for Cancer Research at Westmead Hospital
		Hogg Russell, FRANZCOG CGO	Ph: +61 2 9845 8853 Ext.2145
			Email: Russell_Hogg@wsahs.nsw.gov.au
		Annie Stenlake, BHSM, RN	Ph: +61 2 9845 6801
			Email: annieas@westgate.wh.usyd.edu.au
		Russell Hogg	Principal Investigator
Queensland
	Auchenflower
	Wesley Hospital
		Jim Nicklin, Doctor	Ph: +61 7 3871 2290
			Email: jnicklin@wesley.com.au
		Trudi Cattley, BAppSc	Ph: +61 7 3636 0447
			Email: Trudi_Cattley@health.qld.gov.au
		Jim Nicklin, FANZCOG CGO	Principal Investigator
	Greenslopes
	Greenslopes Private Hospital
		Andreas Obermair	Ph: +61 7 3847 3033
			Email: sue@obermair.info
		Trudi Cattley, BAppSc	Ph: +61 7 3636 0447
			Email: Trudi_Cattley@health.qld.gov.au
		Andreas Obermair, FRANZCOG CGO	Principal Investigator
		Russell Land, FRANZCOG CGO	Sub-Investigator
	Herston
	Royal Brisbane and Women's Hospital
		Andreas Obermair, FRANZCOG CGO	Ph: +61 7 3636 8501 Ext.68501
			Email: andreas_obermair@health.qld.gov.au
		Trudi Cattley, BAppSc	Ph: +61 7 3636 0447
			Email: Trudi_Cattley@health.qld.gov.au
		Andreas Obermair, FRANZCOG CGO	Principal Investigator
		James Nicklin, FANZCOG CGO	Sub-Investigator
		Russell Land, FRANZCOG CGO	Sub-Investigator
	South Brisbane
	Mater Adult Hospital
		Lewis Perrin, FRANZCOG CGO	Ph: +61 7 3844 9932
			Email: lewisperrin@mc.mater.org.au
		Trudi Cattley, BAppSc	Ph: +61 7 3636 0447
			Email: Trudi_Cattley@health.qld.gov.au
		Lewis Perrin, FRANZCOG CGO	Principal Investigator
		Marcelo Nascimento, FRANZCOG CGO	Sub-Investigator
	Townsville
	Mater Misericordiae Hospital Townsville
		Andreas Obermair	Ph: +61 7 3636 5485
			Email: andreas_obermair@health.qld.gov.au
		Trudi Cattley, BAppSc	Ph: +61 7 3636 0447
			Email: Trudi_Cattley@health.qld.gov.au
		Andreas Obermair	Principal Investigator
		James Nicklin	Sub-Investigator
		Lewis Perrin	Sub-Investigator
		Russell Land	Sub-Investigator
	Townsville Hospital
		Andreas Obermair, FRANZCOG CGO	Ph: +61 7 3636 8501
			Email: Andreas_Obermair@health.qld.gov.au
		Trudi Cattley, BAppSc	Ph: +61 7 3636 0447
			Email: Trudi_Cattley@health.qld.gov.au
		Andreas Obermair, FRANZCOG CGO	Principal Investigator
		Russell Land, FRANZCOG CGO	Sub-Investigator
		James Nicklin, FRANZCOG CGO	Sub-Investigator
		Lewis Perrin, FRANZCOG CGO	Sub-Investigator
South Australia
	Adelaide
	Royal Adelaide Hospital Cancer Centre
		Martin Oehler	Ph: +61 8 8222 4816
			Email: martin.oehler@adelaide.edu.au
		Joanne White	Ph: +61 8 8222 2610
			Email: JWhite4@mail.rah.sa.gov.au
		Martin Oehler, MD PhD FRANZCOG	Principal Investigator
Victoria
	Box Hill
	Box Hill Hospital
		Tom Manolitsas	Ph: 03 9594 5387
			Email: manolitsas@pacific.net.au
		Nicole Fairweather	Ph: 03 9594 7917
			Email: Nicole.Fairweather@princehenrys.org
		Tom Manolitsas	Principal Investigator
	Carlton
	Royal Women's Hospital
		Deborah Neesham	Ph: +61 39344 2658
			Email: deborah.neesham@affinityhealth.com
		Margot Osinski	Ph: (613) 8345 3547
			Email: margot.osinski@thewomens.org.au
		Deborah Neesham, MBBS DCH MRACOG FRACOG	Principal Investigator
	East Bentleigh
	Monash Medical Centre - Moorabbin Campus
		Tom Manolitsas, FRANZCOG CGO	Ph: +61 3 9594 5387
		Nicole Fairweather	Ph: +61 3 9594 7917
			Email: Nicole.Fairweather@princehenrys.org
		Tom Manolitsas, FRANZCOG CGO	Principal Investigator
		Tom Jobling, FRANZCOG CGO	Sub-Investigator
Hong Kong
	Pokufulam
	Queen Mary Hospital - Hong Kong
		Hextan Ngan, MBBS, MD, FRCOG
			Email: hysngan@hkucc.hku.hk
		Anne Wang
		Hextan Ngan	Principal Investigator
New Zealand
	Christchurch
	Christchurch Women's Hospital
		Peter Sykes
			Email: peter.sykes@chmeds.ac.nz
		Dianne Harker, MA RN	Ph: 03 364 4624
			Email: dianne.harker@otago.ac.nz
		Peter Sykes	Principal Investigator
		Mike Laney	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00096408
Information obtained from ClinicalTrials.gov on March 18, 2009