A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection for Stage IIIA (N2) Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 429
- 试验地点
- 16
- 主要终点
- Median overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin, etoposide, and radiation therapy with or without surgery in treating patients who have stage IIIA non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival, median (2-year) survival, and long-term (5-year) survival in patients with newly diagnosed, stage IIIA (N2) non-small cell lung cancer treated with radiotherapy concurrently with cisplatin and etoposide with or without surgical resection.
Secondary
- Compare the patterns of local and distant failure in patients treated with these regimens.
- Determine the relationship of tobacco use, alcohol use, and diet with toxicity of these regimens and outcome in both men and women.
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
研究组 & 干预措施
RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
干预措施: cisplatin (Drug)
RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
干预措施: etoposide (Drug)
RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
干预措施: conventional surgery (Procedure)
RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
干预措施: radiation therapy (Radiation)
RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
干预措施: cisplatin (Drug)
RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
干预措施: etoposide (Drug)
RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Median overall survival
时间窗: From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
次要结局
- Median Progression-free survival(From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.)
- Patterns of local and distant failure(From randomization to date of failure (local, regional or distant progression). Analysis occurs after patients have been potentially followed for 2.5 years.)