NCT00609284已完成3 期
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Groupe Oncologie Radiotherapie Tete et Cou5 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2008年2月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 5
- 主要终点
- Progression free survival
研究概览
简要总结
The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
- •Stage III - IV (T0-T4, N0-N2b, M0)
- •Not resected
- •Karnofsky PS>=80
- •Informed consent signed
排除标准
- •Contra indication to chemotherapy or cetuximab
研究组 & 干预措施
1
Experimental
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
干预措施: cetuximab (Drug)
1
Experimental
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
干预措施: Carboplatin, 5FU concomitant (Drug)
1
Experimental
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
干预措施: Radiotherapy (Radiation)
2
Active Comparator
Radiotherapy 70Gy, Erbitux
干预措施: cetuximab (Drug)
2
Active Comparator
Radiotherapy 70Gy, Erbitux
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: 3 years
次要结局
- Loco-regional control(3 years)
研究者
研究点 (5)
Loading locations...
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