Endometrial Cancer Clinical Trial
Official title:
LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
NCT number | NCT00096408 |
Other study ID # | LACE001 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2005 |
Est. completion date | December 2018 |
Verified date | March 2019 |
Source | Queensland Centre for Gynaecological Cancer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 760 |
Est. completion date | December 2018 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | The Wesley Hospital | Auchenflower | Queensland |
Australia | Box Hill Hospital | Box Hill | Victoria |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | Royal Women's Hospital | Carlton | Victoria |
Australia | Monash Medical Centre | Clayton | Victoria |
Australia | Greenslopes Private Hospital | Greenslopes | Queensland |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Cabrini Health | Malvern | Victoria |
Australia | John Hunter Hospital | New Lambton | New South Wales |
Australia | Newcastle Private Hospital | New Lambton Heights | New South Wales |
Australia | King Edward Memorial Hospital for Women | Perth | Western Australia |
Australia | Royal Hospital for Women | Randwick | New South Wales |
Australia | Mater Adult Public Hospital | South Brisbane | Queensland |
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
Australia | St John of God Hospital | Subiaco | Western Australia |
Australia | Mater Misericordiae Hospital Townsville | Townsville | Queensland |
Australia | Townsville Hospital | Townsville | Queensland |
Australia | Westmead Hospital | Westmead | New South Wales |
Hong Kong | Queen Mary Hospital | Pok Fu Lam | |
New Zealand | Christchurch Women's Hospital | Christchurch | Canterbury |
New Zealand | Oxford Clinic Women's Health | Christchurch | |
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
Queensland Centre for Gynaecological Cancer | Cancer Australia, Cancer Council New South Wales, Cancer Council Queensland, Cancer Council Victoria, Cancer Council Western Australia, Gynetech, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., National Health and Medical Research Council, Australia, Queensland Government - Smart Health Research Grant, Tyco Healthcare Group |
Australia, Hong Kong, New Zealand, United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | 4.5 years from surgery | ||
Secondary | Intra/Peri/Post-operative and long-term morbidity | 30 days from surgery | ||
Secondary | Patterns of recurrence | 4.5 years from surgery | ||
Secondary | Pain and analgesia | 1 week, 1 month, 3 months and 6 months postoperative. | ||
Secondary | Quality of Life | Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. |
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