Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 10
- 主要终点
- Proportion of patients developing symptomatic brain metastasis
研究概览
简要总结
For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.
详细描述
For this group of patients, brain metastases are one of the major sites of tumor failure. Radical therapy of symptomatic brain metastases is seldom possible and only very rarely, long term survival can be achieved. PCI has shown to reduce the incidence of brain metastases in patients with non-small cell lung cancer to the same extent as in limited disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient, treated with contemporary chemo-radiation schedule with or without surgery, remains unsettled. Therefore this study is launched, in order to investigate whether PCI should become the standard of care in patients with stage III NSCLC who are treated with curative intention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology)
- •Whole body FDG-PET-scan before start of therapy available: No distant metastases
- •CT or MRI of the brain before the start of radical therapy available: No brain metastases
- •Platinum-based chemotherapy is mandatory
- •Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery
- •Radiotherapy dose without surgery at least a biological equivalent of 60Gy
- •No prior cranial irradiation
- •Patients must sign a study-specific informed consent at the time of registration
排除标准
- •The opposite of the above
结局指标
主要结局
Proportion of patients developing symptomatic brain metastasis
时间窗: 24 months after randomisation
次要结局
- Time to develop neurological symptoms (confirmed or unconfirmed by imaging)(24 months after randomisation)
- Measurement of side effects (CTCAE3.0)(24 months after randomisation)
- Quality of Life(24 months after randomisation)