Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local regional progression free survival
研究概览
简要总结
This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC) non-small cell lung cancer (NSCLC).
详细描述
This study aims to prospectively investigate the local regional control, overall survival, treatment related toxicities and quality of life (QOF) of elderly stage I NSCLC patients receiving stereotactic ablative radiotherapy (SABR) with a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy). Patients' general characteristics, treatment modality, dose-volume histogram (DVH) parameters, toxicity profiling, quality of life, pattern of failure as well as survival time will be prospective recorded for the analysis.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed NSCLC
- •Stage T1- 2 N0M0 based on adequate workup
- •Peripheral tumor
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Inoperable NSCLC
排除标准
- •Pathologically or cytologically confirmed SCLC
- •Direct evidence of regional or distant metastasis
- •Central tumor
- •Past history of malignancy
- •Past history of thoracic irradiation
- •Past history of chemotherapy
- •Past history of thoracic surgery
- •Pure Bronchioalveolar adenocarcinoma
- •Active systemic, pulmonary or pleural lung diseases
- •Pulmonary infection
研究组 & 干预措施
SABR
SABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR)
干预措施: Stereotactic Ablative Radiotherapy (SABR) (Radiation)
结局指标
主要结局
Local regional progression free survival
时间窗: 2 year
Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.
次要结局
- Progression free survival(2 year)
- Overall survival(2 year)
- Grade ≥ 2 radiation induced normal tissue toxicity(1 year)
- Objective response rate(1 month after RT)
- Questionnaire on quality of life(2 year)
研究者
Luhua Wang
Deputy president, Cancer Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences