NCT00521521已完成2 期
A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer
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
- Sanofi
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Objective response rates
研究概览
简要总结
To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx.
- •Locally advanced tumors which are inoperable, or operable but the patient refuses surgery.
- •Age ≥ 18 years and ≤ 70 years.
- •Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial.
排除标准
- •Any metastases (other than cervical ganglia).
- •Cancer of the cavum and the facial structure.
- •Any previous chemotherapy or radiotherapy, irrespective of the reason.
- •Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
- •Weight loss ≥10% of total body weight during the last 3 months.
- •Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular).
- •Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception.
- •Poorly controlled progressive infection.
- •Peripheral neuropathy with NCI grade ≥
- •Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment.
- •Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment.
- •Any other concomitant investigational treatment.
- •Any other concomitant anticancer treatment.
- •Allergy to polysorbate
- •Definitive formal contraindication to corticosteroids.
- •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
docetaxel and cisplatin
Active Comparator
干预措施: docetaxel and cisplatin (Drug)
docetaxel
Experimental
干预措施: docetaxel (Drug)
结局指标
主要结局
Objective response rates
时间窗: evaluated 8 weeks after the end of radiotherapy
次要结局
- Duration of the responses and overall survival(time until progression)
研究者
研究点 (1)
Loading locations...
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