NCT00955695Unknown3 期
A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Nonprogressive on Gefitinib or Erlotinib
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 242
- 主要终点
- Time to symptomatic brain metastases
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Stage IIIB or IV disease
- •Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
- •At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
- •Stable disease allowed provided 1 of the following criteria is met:
- •EGFR mutation (exon 19 or 21)
- •Having ≥ 2 of the following 3 factors:
- •Never smoked
- •Histologically confirmed adenocarcinoma of the lung
- •No evidence of brain metastases by CT scan or MRI within the past 4 weeks
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 150,000/mm^3
- •Bilirubin < 1.5 mg/dL
- •Serum creatinine < 1.5 times upper limit of normal
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Received 1 or 2 prior systemic chemotherapy regimens
排除标准
- 未提供
结局指标
主要结局
Time to symptomatic brain metastases
次要结局
- Progression-free survival
- Overall survival
- Safety and tolerability of prophylactic cranial radiotherapy
- Psycho-neurological effects of prophylactic cranial radiotherapy
- Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically
研究者
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