Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART]
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free survival of patients with completely resected non-small cell lung cancer treated with conformal thoracic radiotherapy vs no radiotherapy.
Secondary
- Determine the toxicity, in particular cardiac and pulmonary toxicity, of these regimens in these patients.
- Compare the local control in patients treated with these regimens.
- Determine patterns of recurrence in patients treated with these regimens.
- Determine the overall survival of patients treated with these regimens.
- Assess second cancers in patients treated with these regimens.
- Assess prognostic factors and predictive factors of treatment effect on disease-free survival and overall survival of patients treated with these regimens.
- Determine the cost per recurrence-free year of life.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disease-free survival (DFS)
时间窗: assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward
次要结局
- Prognostic and predictive factors of treatment effect on DFS and OS(assessed up at the end of the study)
- Acute and late toxicity (with identification of predictive factors of toxicity)(assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event)
- Patterns of failure(assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event)
- Overall survival (OS)(assessed up In case of death whatever the cause)
- Cost per recurrence-free year of life(Assessed up at the end of the study)
- Local control(assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event)
- Second cancers(Assessed up in case of event)