Laparoscopic Approach to Cancer of the Endometrium
This study is ongoing, but not recruiting participants.
Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborators:
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
Cancer Australia
Information provided by:
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00096408
First received: November 9, 2004
Last updated: July 6, 2010
Last verified: July 2010
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial |
Resource links provided by NLM:
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 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Locations
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | |
| Camperdown, New South Wales, Australia, 2050 | |
| John Hunter Hospital | |
| New Lambton, New South Wales, Australia, 2305 | |
| Newcastle Private Hospital | |
| New Lambton Heights, 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 | |
| Townsville Hospital | |
| Townsville, Queensland, Australia, 4810 | |
| Mater Misericordiae Hospital Townsville | |
| 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 | |
| East Bentleigh, Victoria, Australia, 3204 | |
| 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 | |
| Pokfulam, 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
Queensland Cancer Fund
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
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Professor Andreas Obermair, Queensland Centre for Gynaecological Cancer |
| ClinicalTrials.gov Identifier: | NCT00096408 History of Changes |
| Other Study ID Numbers: | LACE001 |
| Study First Received: | November 9, 2004 |
| Last Updated: | July 6, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 23, 2013