Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Probability of Overall Survival at One Year
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, 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. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel.
Secondary
- Assess the progression-free survival and overall survival.
- Assess the toxicity of this regimen.
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
Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
干预措施: Cisplatin (Drug)
Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
干预措施: Docetaxel (Drug)
Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
干预措施: Pemetrexed disodium (Drug)
Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Probability of Overall Survival at One Year
时间窗: at 1 year
Overall Survival at one year using Kaplan-Meier product-limit analysis
次要结局
- Progression-free Survival(Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.)
- Overall Survival(Date of registration to the date of death)
- Safety Outcomes(72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year)
研究者
Shirish M. Gadgeel
Principal Investigator
Barbara Ann Karmanos Cancer Institute