NCT01345669终止3 期
A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 617
- 试验地点
- 162
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（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
Afatinib (BIBW 2992)
Experimental
Once daily
干预措施: Afatinib (Drug)
Placebo
Placebo Comparator
Once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: Up to 5 years
Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.
次要结局
- Disease Free Survival (DFS) Rate at 2 Years(Up to 2 years)
- Percentage of Patient Deaths (Overall Survival (OS))(Up to 5 years)
- Patients With Improved Health Related Quality of Life (HRQOL)(Up to 5 years)
- Time to Deterioration in Health Related Quality of Life (HRQOL)(Up to 5 years)
- Health Related Quality of Life (HRQOL) Scores Over Time(Baseline and 5 years)
研究者
研究点 (162)
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