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| ID | Type | Description | Link |
|---|---|---|---|
| NHMRC 251732 | Other Grant/Funding Number | NHMRC | |
| ANZMTG 01.02 | Other Identifier | Austalian NewZealand Melanoma Trials Group |
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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
| Australian and New Zealand Intensive Care Society Clinical Trials Group | NETWORK |
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This trial seeks to establish the role of post-operative radiotherapy in patients who have had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.
This is a randomised phase III trial which is being performed on patients at high risk of local recurrence after having a lymphadenectomy for stage 3 melanoma. The control arm is surgery alone with radiotherapy reserved for those who recur. The study arm is surgery plus post-operative radiotherapy. All 3 major node sites are eligible. The radiation dose administered is 48Gy in 20 fractions. It is likely to be the only study of its kind ever performed. The target is 230 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-operative RADIOTHERAPY | Active Comparator | Immediate post-operative RADIOTHERAPY |
|
| Delayed Radiotherapy | Experimental | OBSERVATION with delayed radiotherapy for relapse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | 48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control | Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) | |
| Overall survival | Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Burmeister | Princess Alexandra Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Mater Hospital - North sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26206146 | Derived | Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant lymph-node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy (ANZMTG 01.02/TROG 02.01): 6-year follow-up of a phase 3, randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1049-1060. doi: 10.1016/S1470-2045(15)00187-4. Epub 2015 Jul 20. | |
| 22575589 |
| Label | URL |
|---|---|
| Click here for more information about this study on the TROG official website | View source |
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| Toxicity | Interim analysis will occur on annual basis. |
| Quality of life | Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) |
| Crows Nest |
| New South Wales |
| 1585 |
| Australia |
| Calvary Mater Newcastle | Newcastle | New South Wales | 2298 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Westmead Hospital | Wentworthville | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Royal Brisbane Hospital | Herston | Queensland | 4029 | Australia |
| Mater QRI | South Brisbane | Queensland | 4101 | Australia |
| East Coast Cancer Centre | Tugun | Queensland | 4224 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Launceston General Hospital | Launceston | Tasmania | 7250 | Australia |
| Peter MacCallum Cancer Centre | East Melbourne | Victoria | 8006 | Australia |
| Andrew Love Cancer Care Centre, Geelong Hospital | Geelong | Victoria | 3220 | Australia |
| Alfred Hospital | Prahran | Victoria | 3181 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Hospital do Cancer | São Paulo | Brazil |
| Groningen University Hospital | Groningen | Netherlands |
| Auckland Hospital | Auckland | 1001 | New Zealand |
| Christchurch Hospital | Christchurch | 4710 | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Wellington Hospital | Wellington | 7902 | New Zealand |
| Derived |
| Burmeister BH, Henderson MA, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant radiotherapy versus observation alone for patients at risk of lymph-node field relapse after therapeutic lymphadenectomy for melanoma: a randomised trial. Lancet Oncol. 2012 Jun;13(6):589-97. doi: 10.1016/S1470-2045(12)70138-9. Epub 2012 May 9. |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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