Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Overall Survival.
研究概览
简要总结
The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical stage 2, 3A or 3B (unresectable)
- •Histologic evidence of non-small cell carcinoma
- •Age > 18 years
- •Karnofsky performance status 70 or greater
- •No prior radiation to the chest
- •No previous chemotherapy
排除标准
- •Clinical stage 1 or 4
- •Previous malignancies except for non-melanoma skin cancer unless disease free for > 3 years
研究组 & 干预措施
Proton therapy with chemotherapy
Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks.
Proton therapy - 76 Gy in 5 weeks to lung tumor.
干预措施: Proton Radiation Therapy (Radiation)
Proton therapy with chemotherapy
Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks.
Proton therapy - 76 Gy in 5 weeks to lung tumor.
干预措施: Taxol (Drug)
Proton therapy with chemotherapy
Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks.
Proton therapy - 76 Gy in 5 weeks to lung tumor.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Survival.
时间窗: Monthly for duration of participant lifespan. Average lifespan 1-2 years
Median survival time following treatment.
次要结局
- Treatment Related Toxicities.(Monthly for duration of participant lifespan. Average lifespan 1-2 years)