Laparoscopic Approach to Cancer of the Endometrium

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Endometrial Cancer	Procedure: Total Abdominal Hysterectomy; Procedure: Total Laparoscopic Hysterectomy	Phase 3

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	760 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
Study Start Date :	October 2005
Actual Primary Completion Date :	April 2016
Estimated Study Completion Date :	December 2019

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1; 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.; Other Names: TAH; Open hysterectomy
Experimental: 2; 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.; Other Name: Keyhole hysterectomy

Outcome Measures

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Primary Outcome Measures :

1. Disease free survival [ Time Frame: 4.5 years from surgery ]

Secondary Outcome Measures :

1. Intra/Peri/Post-operative and long-term morbidity [ Time Frame: 30 days from surgery ]
2. Patterns of recurrence [ Time Frame: 4.5 years from surgery ]
3. Pain and analgesia [ Time Frame: 1 week, 1 month, 3 months and 6 months postoperative. ]
4. Quality of Life [ Time Frame: Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes 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

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Locations

Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia, 2305
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Royal Hospital for Women
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia, 2050
Australia, Queensland
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Adult Public Hospital
South Brisbane, Queensland, Australia, 4101
Mater Misericordiae Hospital Townsville
Townsville, Queensland, Australia, 4810
Townsville Hospital
Townsville, Queensland, Australia, 4810
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Royal Women's Hospital
Carlton, Victoria, Australia, 3168
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Cabrini Health
Malvern, Victoria, Australia, 3144
Australia, Western Australia
King Edward Memorial Hospital for Women
Perth, Western Australia, Australia, 6008
St John of God Hospital
Subiaco, Western Australia, Australia, 6904
Hong Kong
Queen Mary Hospital
Pok Fu Lam, Hong Kong
New Zealand
Christchurch Women's Hospital
Christchurch, Canterbury, New Zealand
Oxford Clinic Women's Health
Christchurch, New Zealand
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom

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

Cancer Council Queensland

Cancer Council New South Wales

Cancer Council Victoria

Cancer Council Western Australia

Cancer Australia

Investigators

Principal Investigator:	Andreas Obermair	Queensland Centre for Gynaecological Cancer

More Information

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Additional Information:

Gynaecological Oncology website 

QCGC Research 

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

Responsible Party:	Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:	NCT00096408 History of Changes
Other Study ID Numbers:	LACE001
First Posted:	November 9, 2004
Last Update Posted:	April 5, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Queensland Centre for Gynaecological Cancer:

Hysterectomy; Endometrial; Endometrium; Uterus; Cancer; Carcinoma; Adenocarcinoma	Stage 1; Laparoscopy; Abdominal; Total; Surgery; Quality of Life; Disease-free survival

Additional relevant MeSH terms:

Endometrial Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms	Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female