NCT00772681已完成4 期
Phase IV Clinical Study Evaluating The Efficacy of Chemoradiotherapy Following Neoadjuvant Treatment With Docetaxel and Cisplatin in Indifferentiated and Non-keratinized Squamous Cell Carcinoma of Nasopharynx
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Complete response rate after neoadjuvant chemotherapy
研究概览
简要总结
- To assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival.
- Time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed, patients with stage T2b-T4N1 or TanyN2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy.
- •ECOG Performance Status is 0-1
- •Weight loss within last 6 months <10% of body weight
- •Acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
排除标准
- •Patients with stage IVC or metastatic disease
- •Patients treated with chemotherapy for nasopharyngeal cancer
- •Patients treated with radiotherapy to head and neck region
- •Concomitant use of another anti-cancer therapy
- •Patients treated with amifostine or pilocarpine during protocol treatment.
- •Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 6 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
- •Presence of other tumours different from carcinoma of the skin except melanoma and carcinoma in situ of the breast and cervix with disease free survival less than 5 years.
- •Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
- •Social or psychological condition that render the patient inadequate for the follow-up of the study
- •Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: docetaxel and cisplatin (Drug)
结局指标
主要结局
Complete response rate after neoadjuvant chemotherapy
时间窗: From the start date of the treatment to the date of first documented progression of disease or at least until 2 years follow-up period
次要结局
- Percentage of patients whose is disease controlled locally or regionally(from the start date of the treatment to the date of first documented local or regional tumor progression)
- Median length of overall survival(time interval from the date of treatment to the date of death or at least until 2 years follow-up period)
- Median length of disease free survival(time interval from the date of treatment to the date of death or at least until 2 years follow-up period)
- Percentage of alive patients without metastatis(from the start date of the treatment to the date of first documented distant metastasis)
研究者
研究点 (1)
Loading locations...
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