NCT00238875已完成2 期
A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
Haruhiko Fukuda16 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2004年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 16
- 主要终点
- 3-years overall survival
研究概览
简要总结
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
详细描述
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer，the following questions should be answered. Can SRT be an alternative standard treatment modality for inoperable patients? Can SRT can be a comparable standard treatment modality with lobectomy for operable patients? 12 Gy is the daily dose at the isocenter，and 48 Gy in total by 4 fractions will be irradiated by stereotactic irradiation over 4 to 8 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer
- •Stage IA with images within 28 days
- •No other intrathoracic lesions
- •Dose constraints of the organs at risk seem to be limited within range
- •Operable (Standard or Limited surgery) or Inoperable
- •No previous thoracic radiation
- •No previous chemotherapy
- •ECOG PS=0-2
- •Respiratory function (<=14 days) PaO2>=60 torr FEV1.0>=700 ml
- •Written informed consent
排除标准
- •No apparent radiation pneumonitis and fibrosis
- •No active tuberculosis without oral drugs
- •No double cancer
- •No pregnancy
- •No psychiatric disorder
- •No steroid administration
研究组 & 干预措施
1
Experimental
Procedure/Surgery: stereotactic body radiation therapy
干预措施: stereotactic body radiation therapy (Procedure)
结局指标
主要结局
3-years overall survival
时间窗: During the study conduct
次要结局
- Overall survival(During the study conduct)
- acute complications(within 8 weeks from starting treatment day)
- late complications(after 8 weeks from starting treatment day)
- patterns of relapse(During the study conduct)
- 3-years local relapse free survival(During the study conduct)
- relapse-free survival(During the study conduct)
- local-relapse free survival(During the study conduct)
- serious complication rate(During the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group
研究点 (16)
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