NCT00623558已完成2 期
A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.
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
- •Unresectable, locally advanced (cT4b &/or cN2-3) HNSCC
- •ECOG performance status 0-1
- •Age 18 or older than 18 years
- •Measurable disease by RECIST criteria
- •Having signed informed consent
- •ALT and AST<2.5 times ULN
- •Serum albumin level ≥3.0g/dL
- •Serum AKP < 2.5 times ULN
- •Bilirubin level < 1.5mg/dL
- •Serum creatinine <1.5 times ULN
- •WBC>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet>75,000/mm3, Hb>9g/dl
排除标准
- •Previous cytotoxic chemotherapy for HNSCC
- •Radiotherapy for targeted lesions within six months
- •Previous EGFR pathway-targeting therapy
- •Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
- •Distant metastatic disease
- •Heart failure, coronary artery disease, myocardial infarction within the last 6 months
- •Known allergy to any study treatment
- •Pregnancy or lactation period
- •Any investigational agent within the past 28 days
- •Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
- •Legal incapacity
研究组 & 干预措施
1
Active Comparator
Docetaxel+CDDP
干预措施: Docetaxel (Drug)
1
Active Comparator
Docetaxel+CDDP
干预措施: Cisplatin (Drug)
2
Experimental
Docetaxel+CDDP+Cetuximab
干预措施: Cetuximab (Drug)
2
Experimental
Docetaxel+CDDP+Cetuximab
干预措施: Docetaxel (Drug)
2
Experimental
Docetaxel+CDDP+Cetuximab
干预措施: Cisplatin (Drug)
结局指标
主要结局
Response rate
时间窗: after induction treatment
次要结局
未报告次要终点
研究者
Dae Seog Heo
Professor
Seoul National University Hospital
研究点 (1)
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