NCT01280318已完成1 期
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth
研究概览
简要总结
The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome
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
- •Age 18 years and over
- •_ histological proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharinx or larynx
- •Patients selected for a primary surgical treatment
- •no distant metastases
- •no active second malignancy during the last 5 years except non melanoma skin cancer or carcinoma in situ of the cervix
- •no prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery
- •life expectancy of more than 3 months
- •not pregnant or nursing; fertile patients both male and female, must use effective contraception
- •absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •signed informed consent
- •performance status ECOG 0-1
排除标准
- •Nasopharynx cancer
- •past or current malignancy other than HNSCC
- •performance ECOG status more than 2
- •concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •use of any investigational agents within 4 weeks prior to entry
- •Previous exposure to EGFR targeting therapy
- •known grade hypersensitivity to cetuximab
- •legal incapacity or limited legal capacity or medical or psychological condition which in the opiniion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
结局指标
主要结局
identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth
时间窗: 5 months
次要结局
- Compare the results of group I with groups II and III(5 months)
研究者
研究点 (2)
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