NCT00745797终止3 期
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial
Yi-Long Wu1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .
研究概览
简要总结
- Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.
- The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
- The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).
详细描述
- Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .
- PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
- But its impact on overall and disease free survival is uncertain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
- •No previous history of radiotherapy and surgery of brain
- •Agree to radiotherapy
- •age > 18 and <75 years
- •ECOG performance status 1 or less
- •Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
- •Have provided informed consent
排除标准
- •Seizure cannot be controled by the drugs
- •Combined with other disease of the brain such as tumour or infarction
- •Hypersensitivity to MR enhancer
结局指标
主要结局
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .
时间窗: 2.5years
次要结局
- 1year survival,overall survival,incidence rate of radioactive brain injured(2 years)
研究者
Yi-Long Wu
Professor, director
Chinese Society of Lung Cancer
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLCNon Small Cell Lung Cancer (NSCLC)Radical TreatmentStage III Non-Small Cell Lung CancerNCT01282437Maastricht Radiation Oncology315
招募中
3 期
Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small cell lung cancer: A phase III randomized study (NVALT-11/ DLCRG-02).10038666lung cancerNL-OMON35252ederlandse Vereniging van artsen voor Longziekten en Tuberculose450
已完成
2 期
Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Active Brain MetastasisNSCLC Stage IVNCT06501378Fudan University40
招募中
2 期
Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Stable Brain MetastasisNSCLC Stage IVBrain MetastasesNCT06501391Fudan University54
已完成
不适用
Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) PatientsNSCLCNCT01290809Maastricht Radiation Oncology170