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| Name | Class |
|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
| Tyco Healthcare Group | INDUSTRY |
| Gynetech | INDUSTRY |
| Queensland Government - Smart Health Research Grant |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Total Abdominal Hysterectomy |
|
| 2 | Experimental | Total Laparoscopic Hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Abdominal Hysterectomy | Procedure | For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 4.5 years from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intra/Peri/Post-operative and long-term morbidity | 30 days from surgery | |
| Patterns of recurrence | 4.5 years from surgery | |
| Pain and analgesia |
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Inclusion Criteria:
Patients who may be included for this study must have the following:
Exclusion Criteria:
Patients will be excluded from participating from the study if they have any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Obermair | Queensland Centre for Gynaecological Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| John Hunter Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678497 | Background | 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. doi: 10.1016/j.cct.2006.03.004. Epub 2006 May 5. | |
| 35576502 | Derived |
| Label | URL |
|---|---|
| Gynaecological Oncology website | View source |
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| UNKNOWN |
| National Health and Medical Research Council, Australia | OTHER |
| Cancer Council Queensland | OTHER |
| Cancer Council New South Wales | OTHER |
| Cancer Council Victoria | OTHER |
| Cancer Council Western Australia | UNKNOWN |
| Cancer Australia | OTHER |
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|
| Total Laparoscopic Hysterectomy | Procedure | 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. |
|
|
| 1 week, 1 month, 3 months and 6 months postoperative. |
| Quality of Life | Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. |
| New Lambton |
| New South Wales |
| 2305 |
| Australia |
| Newcastle Private Hospital | New Lambton Heights | New South Wales | 2305 | Australia |
| Royal Hospital for Women | Randwick | New South Wales | 2031 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2050 | Australia |
| The Wesley Hospital | Auchenflower | Queensland | 4066 | Australia |
| Greenslopes Private Hospital | Greenslopes | Queensland | 4120 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Mater Adult Public Hospital | South Brisbane | Queensland | 4101 | Australia |
| Mater Misericordiae Hospital Townsville | Townsville | Queensland | 4810 | Australia |
| Townsville Hospital | Townsville | Queensland | 4810 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Royal Women's Hospital | Carlton | Victoria | 3168 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Cabrini Health | Malvern | Victoria | 3144 | Australia |
| King Edward Memorial Hospital for Women | Perth | Western Australia | 6008 | Australia |
| St John of God Hospital | Subiaco | Western Australia | 6904 | Australia |
| Queen Mary Hospital | Pok Fu Lam | Hong Kong |
| Christchurch Women's Hospital | Christchurch | Canterbury | New Zealand |
| Oxford Clinic Women's Health | Christchurch | New Zealand |
| Royal Infirmary of Edinburgh | Edinburgh | United Kingdom |
| Gebski V, Obermair A, Janda M. Toward Incorporating Health-Related Quality of Life as Coprimary End Points in Clinical Trials: Time to Achieve Clinical Important Differences and QoL Profiles. J Clin Oncol. 2022 Jul 20;40(21):2378-2388. doi: 10.1200/JCO.21.02750. Epub 2022 May 16. |
| 28350928 | Derived | 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. |
| 24007947 | Derived | 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. |
| 22503396 | Derived | 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. |
| 20638899 | Derived | 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. |
| QCGC Research | View source |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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