IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and tolerability
研究概览
简要总结
The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed untreated NPC patients
- •locoregionally advanced (T3-4 or N2-3 M0)
- •18-65 years
- •with MRI examinations
- •With written consent
排除标准
- •Without a second cancer
- •Pregnancy
- •With other severe diseases (blood,liver ,kidney or heart diseases)
- •Could not be staged properly
- •Without written consent
研究组 & 干预措施
cetuximab
Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.
干预措施: Intensity-modulated radiotherapy (Radiation)
cetuximab
Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.
干预措施: Concurrent chemotherapy with paclitaxel and nedaplatin (Drug)
cetuximab
Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.
干预措施: Cetuximab (Biological)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and tolerability
时间窗: 6 months
Number of Participants with Adverse Events as a Measure of Safety
时间窗: 6 months
次要结局
- Progress free survival(24 months)
研究者
Dr. Xia He
Director of the department of radiation oncology
Jiangsu Cancer Institute & Hospital