A Prospective Randomized Multicenter Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of Stage IIb-c and III Cutaneous Malignant Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,300
- 试验地点
- 28
- 主要终点
- Overall survival
研究概览
简要总结
It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.
详细描述
The patients are randomized 1:1 to routine follow up for 3 years with regular doctors´ appointments according to national guidelines and the same follow up but with the addition of whole body CT or Positron Emission Tomography (PET) scans and blood tests. An interim analysis will be conducted when 1000 patients have been included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •At least 18 years of age.
- •Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III.
- •Sufficient renal function for i.v. contrast scannings.
排除标准
- •The patient is assessed as unfit to receive treatment in the case of recurrence.
- •Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis).
- •Inability to provide informed consent or refusal to do so.
- •Inability to comply with the control or intense follow-up program.
- •Participation in other clinical trials interfering with the control-program.
- •Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer).
- •Pregnancy or currently planned pregnancy.
结局指标
主要结局
Overall survival
时间窗: At 5 years
Measured from date of inclusion
次要结局
- Quality of life/QLQ30(During the 3 year intervention period)
- Quality of life/HAD(During the 3 year intervention period)