Laparoscopic Approach to Cancer of the Endometrium
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ClinicalTrials.gov Identifier: NCT00096408 |
Recruitment Status
:
Active, not recruiting
First Posted
: November 9, 2004
Last Update Posted
: April 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometrial Cancer | Procedure: Total Abdominal Hysterectomy Procedure: Total Laparoscopic Hysterectomy | Phase 3 |
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 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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096408
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 |
Principal Investigator: | Andreas Obermair | Queensland Centre for Gynaecological Cancer |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Queensland Centre for Gynaecological Cancer |
ClinicalTrials.gov Identifier: | NCT00096408 History of Changes |
Other Study ID Numbers: |
LACE001 |
First Posted: | November 9, 2004 Key Record Dates |
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 |