NCT03595644已完成2 期
Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with a targeted agent such as gefitinib, erlotinib and icotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 must have biopsy proven metastatic NSCLC (Stage IV).
- •Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
- •Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.
- •Age 18 to 75 years old.
- •Patients must have measurable disease at baseline.
- •The amount of metastatic focus <
- •ECOG score 0-2
- •Adequate normal organ and marrow function for TKI treatment and radiotherapy.
- •Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)
- •Patients must provide written informed consent to participate in the study.
排除标准
- •Patients who previously received radiotherapy to the primary site.
- •Patient can't tolerate radiotherapy or targeted therapy;
- •Pregnant or nursing women
研究组 & 干预措施
SBRT plus TKI group
Experimental
SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment
干预措施: SBRT+TKI (Radiation)
TKI treatment group
Active Comparator
Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid
干预措施: TKI (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause
次要结局
- OS(3 year)
研究者
研究点 (1)
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