NCT00433563已完成不适用
A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT]
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 547
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare overall survival of patients with limited stage small cell lung cancer treated with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily radiotherapy.
Secondary
- Compare local progression-free survival of patients treated with these regimens.
- Compare metastasis-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare response rates in patients treated with these regimens.
- Compare the cytotoxic dose intensity of these regimens in these patients.
- Compare the dose intensity of two different schedules of radiotherapy in these patients.
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
Overall survival
时间窗: August 2015
次要结局
- Radiotherapy dose intensity(August 2015)
- Local progression-free survival(August 2015)
- Metastasis-free survival(August 2015)
- Toxicity of treatment(August 2015)
- Cytotoxic dose intensity(August 2015)
研究者
研究点 (2)
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