Preoperative Chemotherapy and Radiotherapy Concomitant to Cetuximab in Non-Small Cell Lung Cancer (NSCLC) Patients With IIIB Disease - A Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 15
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin 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. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see how well it works in treating patients with stage IIIB non-small cell lung cancer that can be removed by surgery.
详细描述
OBJECTIVES:
- To evaluate the efficacy and safety of neoadjuvant sequential chemoimmunotherapy comprising cetuximab, cisplatin, and docetaxel before radiotherapy and cetuximab followed by surgery in patients with resectable stage IIIB non-small cell lung cancer.
OUTLINE: This is a multicenter study.
- Chemoimmunotherapy (courses 1-3): Patients receive chemoimmunotherapy comprising cetuximab IV over 1-2 hours on days 1, 8, and 15; cisplatin IV over 1 hour on days 1 and 2; and docetaxel IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) on days 3-8 or a single dose of pegfilgrastim the day after chemotherapy. Treatment repeats every 3 weeks for 3 courses.
- Radiotherapy (course 4): Beginning on day 1 of week 10, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy 5 days a week for 3 weeks. Patients also receive cetuximab IV over 1 hour on days 1, 8, and 15.
- Surgery: Beginning 21-28 days after completion of radiotherapy, patients undergo surgery.
After completion of study treatment, patients are followed every 3 months for 2 years and every 6 months for 3 years.
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 75 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
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery
干预措施: cetuximab (Drug)
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery
干预措施: cisplatin (Drug)
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery
干预措施: docetaxel (Drug)
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery
干预措施: Radiotherapy (Radiation)
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery
干预措施: Surgery (Procedure)
结局指标
主要结局
Progression-free survival
时间窗: at 1 year (+/- 1 month)
次要结局
- Treatment-related death during chemoimmunotherapy, radioimmunotherapy, and perioperatively(30 days after surgery)
- Metabolic response evaluated by PET(At baseline and after chemo-immunotherapy)
- Complete pathological response(After surgery)
- Response status after chemoimmunotherapy and radioimmunotherapy(After chemoimmunotherapy and after radioimmunotherapy)
- Operability(Before trial treatment)
- Overall survival(At the end of the follow-up phase (max. 5 years after treatment termination or surgery))
- Adverse events(During the all trial treatment until 30 days after surgery or treatment stop)