NCT01301248Unknown2 期
Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
Theagenio Cancer Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Determine safety and toxicity of combination
研究概览
简要总结
To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment
详细描述
Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio). Groups will be matched age, sex, PS, and disease site.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed HNSCC of oral cavity, larynx, oropharynx or
- •hypopharynx; age of 18 years or more
- •adequate liver (SGOT, SGPT, ALP ≤ 3x normal)
- •kidneys (creatinine clearance ≥ 60ml/min
- •heart (no arrythmias, no heart failure) and
- •bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function
- •ECOG performance status 0 or 1 and
- •stage III or IVa to b with measurable lesions
- •written informed consent
排除标准
- •prior radiotherapy
- •chemotherapy
- •concurrent active malignancies
- •pregnancy
- •breast-feeding
结局指标
主要结局
Determine safety and toxicity of combination
时间窗: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.
次要结局
- Overall survival time(Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months)
- Progression-free survival time(Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months)
- Response(Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months)
研究者
研究点 (2)
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