Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the maximum tolerated dose of stereotactic radiosurgery in patients with locally advanced non-small cell lung cancer undergoing concurrent chemoradiotherapy. (Phase I)
- Assess the response rate (complete and partial response) in these patients by RECIST criteria. (Phase II)
Secondary
- Determine the tolerability. (Phase I)
- Assess the quality of life of these patients by QLQ-C30 v3. (Phase I)
- Assess the overall and disease-free survival of these patients. (Phase II)
- Assess progression-free survival of these patients. (Phase II)
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
- 18 Years 至 120 Years（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
CyberKnife irradiation
干预措施: CK (Device)
结局指标
主要结局
Maximum tolerated dose (phase I)
时间窗: 5 years
Overall response rate by RECIST (phase II)
时间窗: 5 years
次要结局
未报告次要终点