A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 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
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer
详细描述
OBJECTIVES:
Primary
Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
Secondary
Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.
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
- •good response( CR/PR) to Erlotinib or Gefitinib.
- •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 -
研究组 & 干预措施
prophylactic cranial irradiation
Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
干预措施: Prophylactic cranial irradiation (Radiation)
prophylactic cranial irradiation
Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
干预措施: Erlotinib /Gefitinib (Drug)
Conctrol
Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
干预措施: Erlotinib /Gefitinib (Drug)
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
- overall survival(baseline to date of death from any cause)