Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination With Radiation for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II, Multi-Center Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of Grade 3-4 Esophagitis
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with selenomethionine and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
- Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosuppression, can be reduced with this regimen.
Secondary
- Estimate response rate, failure-free survival, and overall survival of these patients.
- Correlate selenium levels with degree of observed adverse events.
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
CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
干预措施: carboplatin (Drug)
CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
干预措施: paclitaxel (Drug)
CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
干预措施: selenomethionine (Dietary Supplement)
CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
干预措施: laboratory biomarker analysis (Other)
CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Incidence of Grade 3-4 Esophagitis
时间窗: During study treatment, up to 6 weeks
Incidence of Grade 3-4 Pneumonitis
时间窗: During study treatment, up to 6 weeks
Incidence of Grade 3-4 Myelosuppression
时间窗: During study treatment, up to 6 weeks
次要结局
- Failure-free Survival(Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.)
- Response Rate(1 month post-treatment, then q 3 months x 4)
- Selenium Level by Incidence of SAE(Pre-treatment and every week for 6 weeks prior to chemotherapy.)
- Overall Survival(Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter)