A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 20
- 主要终点
- Local Control
研究概览
简要总结
A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1/T2a N0 M0 NSCLC, either by: (a) histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and CT thorax and/or PET-CT evidence, or (b) a suspicious growing nodule on serial CT imaging, with malignant PET Fluorodeoxyglucose (FDG) avidity, for which a biopsy would be extremely risky.
- •Deemed medically inoperable (as reviewed by a thoracic surgeon and defined as surgically resectable but, because of underlying physiological medical problems [e.g. chronic obstructive pulmonary disease (COPD), heart disease], surgery is contraindicated) or Radiotherapy is preferred by the patient due to high operable risk.
排除标准
- •Less than 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
- •Prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer).
- •History of ataxia telangiectasia.
- •Previous radiotherapy (RT) in the vicinity of the tumour, such that significant overlap could occur.
- •Previous pneumonectomy with Stage I lung cancer in the remaining lung.
- •Diagnosis of idiopathic pulmonary fibrosis and/or interstitial lung disease.
- •Planned for other anticancer therapy (chemotherapy, biological targeted therapy).
- •Female, who is currently pregnant or lactating.
- •Geographic inaccessibility for follow-up.
- •Unable to provide informed consent.
结局指标
主要结局
Local Control
时间窗: 5 years
Local control is the absence of local recurrence during the study period. This is the time from randomization to primary tumour failure or marginal failure.
次要结局
- Lung Cancer-Specific Survival(5 years)
- Event-Free Survival(5 years)
- Toxicity(5 years)
- Disease-Free Survival(5 years)
- Overall Survival(5 years)
- Radiation Treatment-Related Death(1 to 12 months)
- Quality of Life(2 years)
- Cost-Utility(3 years)