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

皮肤癌在澳大利亚非常常见，但通常出现在早期，并且是高度可治愈的。恶性黑色素瘤是第三常见的皮肤癌，但却是最致命的。当黑色素瘤从皮肤上的原发部位扩散时，它最常表现为区域淋巴结盆中的肿块（淋巴结转移）。含有恶性淋巴结（或腺体）的区域取决于皮肤上原发性黑色素瘤发生的位置。因此，手臂或胸部的原发性黑色素瘤预计会扩散到腋窝（腋窝）的淋巴结，或腿上的淋巴结扩散到腹股沟，或面部淋巴结扩散到颈部。标准治疗是手术（淋巴结切除术，治疗性淋巴结清扫术），以消除恶性淋巴结，通常是非常有效的治疗。然而，一些患者在淋巴结手术区域中遭受黑色素瘤复发，这可能变得难以控制。淋巴结手术后不久，早期放射治疗已被重新使用（称为辅助放射治疗，因为所有已知的癌症都已通过手术切除），以尝试降低手术切除（完全切除）淋巴结区域中黑色素瘤重新生长的风险。本试验旨在回答淋巴结手术区域增加放疗是否能改善该诊断患者的结局。这些结果包括可能降低淋巴结手术区域黑色素瘤的复发率，找出每种治疗（手术与手术加放疗）副作用的频率和严重程度的差异，以及患者总体上是否有任何生活质量差异。该试验还将研究在手术时采集的病理标本中的哪些迹象可能表明何时最好采用放射治疗。该试验的目标是在4年内从澳大利亚和新西兰的多个中心招募270名患者。

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.