Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 41
- 主要终点
- Locoregional control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Regional macroscopic nodal metastatic melanoma in one nodal basin region only which has been completely resected.
- •melanoma involving lymph nodes at high risk of local recurrence (details in protocol)
- •No evidence of metastases
- •No active major cancer within 5 years
- •Normal blood tests
- •WHO performance status of 0 or 1
- •Radiotherapy must be able to be commenced within 12 weeks of lymphadenectomy
- •Patient must not be pregnant and if fertile must use a medically acceptable contraceptive throughout treatment
- •No major concurrent illnesses likely to cause death within 2 years
- •Written informed consent has been given
排除标准
- •Evidence of active or previous local recurrence or in transit disease
- •Evidence of distant metastases on clinical or radiological investigation
- •Patients with prior cancers
结局指标
主要结局
Locoregional control
时间窗: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
次要结局
- 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))
- 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))