NCT01104714已完成不适用
Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
Centre Hospitalier Universitaire de Nīmes14 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- %change in tumor volume before and after chemotherapy (baseline versus 62 days)
研究概览
简要总结
The purpose of this study is to determine if there is a correlation between tumor response after 3 doses of chemotherapy by induction using Docetaxel, Cisplatine and 5-Fluorouracile for advanced stage epidermoid carcinomas of the upper aero digestive tract and the presence of one or a combination of 3 genetic polymorphisms and/or 5 intra-tumoral transcriptional modifications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Squamous cell carcinoma originating in the mouth, oropharynx, larynx or hypopharynx has been histologically documented.
- •The disease is at one of the following UICC 2002 stages, regardless of ganglion status: T3 MO or T4 MO
- •Treatment via chemotherapy, radiotherapy or surgery (except for the diagnostic biopsy) has not started
- •The pluridisciplinary committee as ruled out surgical options for technical or functional reasons
- •Absence of distant metastases
- •OMS general health status between 0 and 2
- •Patient has given informed consent
- •Patient is affiliated with a social security system
排除标准
- •Undifferentiated squamous cell carcinomas in the nasopharynx (UCNT)
- •Another cancer priorly treated with one of the following chemotherapies: Docetaxel, Cisplatin, 5-Fluorouracile
- •Creatininemia > 2 mg/dl and/or creatinine clearance < 60ml/min
- •Patient under guardianship
- •Presence of another severe pathology including:
- •severe or chronic cardiac, renal and/or hepatic insufficiencies
- •severe medullary hypoplasia
- •severe autoimmune disease
- •psychosis or senility
结局指标
主要结局
%change in tumor volume before and after chemotherapy (baseline versus 62 days)
时间窗: 62 days
Tumor volume is calculated according to Labadie et al 2000
次要结局
未报告次要终点
研究者
研究点 (14)
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