Concurrent Nimotuzumab and Intensity-modulated Radiotherapy for Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete response (CR) rate at 1 month after radiotherapy
研究概览
简要总结
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
详细描述
Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma
排除标准
- •A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions, supposed to live less than 6 months.
研究组 & 干预措施
Nimotuzumab
Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).
干预措施: Nimotuzumab (Drug)
Nimotuzumab
Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).
干预措施: Radiation (Radiation)
结局指标
主要结局
Complete response (CR) rate at 1 month after radiotherapy
时间窗: 1 month after radiotherapy
CR was defined as a complete lack of unequivocal soft tissue mass in the primary site and cervical lymph nodes with a short axis of less than 10 mm assessed by fiber-optic nasopharyngoscopy and MRI of the head and neck according to the Response Evaluation Criteria in Solid Tumors V.1.1 (RECIST V.1.1).
次要结局
未报告次要终点
研究者
Chen Xiaozhong
Director of department
Zhejiang Cancer Hospital