A trial of surgery versus surgery plus adjuvant radiotherapy in patients with resected nodal metastatic melanoma.

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Skin cancer is extremely common in Australia but usually presents early and is highly curable. Malignant melanoma is the third commonest skin cancer, however is the most lethal. When melanoma spreads away from its primary site on the skin it most frequently presents as a lump in the regional node basin (lymph node metastases). The region containing malignant lymph nodes (or glands) is dependent on where the primary melanoma occurred on the skin. Thus a primary melanoma on the arm or chest would be expected to spread to nodes in the axilla (armpit) or on the leg to the groin, or on the face to the neck. The standard treatment is surgery (lymphadenectomy, therapeutic lymph node dissection) to remove the malignant nodes, and is usually very effective treatment. However some patients suffer recurrence of the melanoma in the region of the lymph node surgery which can become difficult to control. Early radiotherapy has been variably used soon after the lymph node surgery (called adjuvant radiotherapy as all the known cancer has been removed by surgery) to try and reduce the risk of the melanoma regrowing in the region of the surgically removed (completely resected) nodes. This trial is designed to answer the question as to whether the addition of radiotherapy to the region of lymph node surgery does improve outcomes for patients with this diagnosis. These outcomes include potentially reducing the rate of recurrence of melanoma in the region of the lymph node surgery, finding out the difference in the frequency and severity of side effects for each of the treatments (surgery versus surgery plus radiotherapy) and as a result whether patients on the whole have any difference in their quality of life. The trial will also study what signs in the pathology specimen taken at the time of the operation might indicate when radiotherapy would be best employed. The trial aims to accrue 270 patients over 4 years from multiple centres around Australia and New Zealand.