NCT01271439已完成2 期
A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3 Month Complete Response Rate + Partial Response Rate
研究概览
简要总结
This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologic diagnosis of nasopharyngeal carcinoma
- •Range from 18～69 years old
- •T3-4，N0-2，M0 (AJCC 2009)
- •Nonmetastatic diseases
- •WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- •ALT or AST < 1.5×ULN、bilirubin < 1.5×ULN
- •0Serum creatinine < 1.5×ULN
排除标准
- •Distance metastases
- •Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy)
- •Second malignancy within 5 years
- •Precious therapy with an investigational agent
- •Uncontrolled seizure disorder or other serious neurologic disease
- •≥ Grade Ш allergic reaction to any drug including in this study
- •Clinically significant cardiac or respiratory disease
- •Creatinine clearance < 30ml/min
- •Drug or alcohol addition
- •Do not have full capacity for civil acts
- •Severe complication, active infection
- •Concurrent immunotherapy or hormone therapy for other diseases
- •Pregnancy or lactation
研究组 & 干预措施
cetuximab
Experimental
干预措施: Cetuximab (Drug)
结局指标
主要结局
3 Month Complete Response Rate + Partial Response Rate
时间窗: 3 Months
According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions.
次要结局
- One-year locoregional control rate(1 year)
- Three-year locoregional control rate(3 years)
- One-year disease free survival rate(1 year)
- Three-year disease free survival rate(3 years)
- One-year overall survival rate(1 year)
- Three-year overall survival rate(3 years)
- The relationship between 3 years overall survival rate and expression of EGFR(3 years)
- Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life(3 years)
- The relationship between 3 years overall survival rate and amplification of EGFR(3 years)
- The relationship between 3 years overall survival rate and mutation of EGFR(3 years)
研究者
Zhao Chong
MD
Sun Yat-sen University
研究点 (1)
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