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

对切​​除的淋巴结转移性黑色素瘤患者进行手术与手术加辅助放疗的试验。

• 批准号: nhmrc : 251732
• 负责人: A/Pr Richard Fisher
• 金额: $ 20.34万
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2003
• 资助国家: 澳大利亚
• 起止时间: 2003-01-01 至 2005-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/trial-surgery-versus-metastatic-melanoma/95182
• 关键词: trial; surgery; versus; plus; adjuvant

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.

皮肤癌在澳大利亚非常常见，但通常出现得很早，而且治愈率很高。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，最常见的表现为区域结盆内的肿块(淋巴转移)。含有恶性淋巴结(或腺体)的区域取决于皮肤上发生原发黑色素瘤的位置。因此，手臂或胸部的原发黑色素瘤可能会扩散到腋下(腋窝)或腿部到腹股沟，或面部到颈部的结节。标准的治疗方法是手术(淋巴清扫术、治疗性淋巴清扫术)切除恶性结节，通常是非常有效的治疗方法。然而，一些患者的黑色素瘤复发在淋巴结手术区域，这可能会变得难以控制。早期放射治疗在淋巴结手术后不久(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)被不同程度地使用，以试图降低黑色素瘤在手术切除(完全切除)的淋巴结区域重新生长的风险。这项试验旨在回答这样一个问题，即在淋巴结手术区域增加放射治疗是否确实改善了患有这种诊断的患者的预后。这些结果包括潜在地降低淋巴结手术区域的黑色素瘤复发率，找出每种治疗(手术和手术加放射治疗)副作用的频率和严重程度的差异，以及患者总体上是否在他们的生活质量方面有任何差异。这项试验还将研究手术时采集的病理标本中的哪些迹象可能表明何时最佳使用放射治疗。这项试验的目标是在4年内从澳大利亚和新西兰的多个中心招募270名患者。