EUCTR2006-002187-25-SE进行中（未招募）不适用
A multicenter, open label, non-randomised phase II study with induction chemotherapy with Cisplatin and 5-fluorouracil as combined with accelerated radiotherapy and Erbitux for locally advanced unresectable squamous cell carcinoma
Radiumhemmet, Karolinska University Hospital0 个研究点目标入组 90 人开始时间: 2006年12月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed squamous cell carcinoma of the head and neck - stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable.
- •Patients must have evaluable and/or measureable disease
- •Age =18 years
- •Performance status (WHO) of 0-1.
- •Patient must have a life expectancy of at least 3 months allowing adequate follow-up of toxicity evaluation.
- •Previously untreated with chemo-, immuno- or radiotherapy
- •Adequate hematological function defined as WBC =3 x 109/litre and platelets =100 x 109litre, ANC ³1.5 x 109litre and HB > 100 g/L
- •Adequate renal function defined as creatinine clearence = 50 ml/min
- •Written informed consent must be obtained according to the local Ethics Committee requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient with distant metastatic disease
- •Oral stage I-II, oropharyngeal ca T1-T2 or N0-N1, nasopharyngeal, lipcancer, glottic ca stage I-II and cancer of the paranasal sinuses.
- •Previous or some other concomitant malignancy, less than 5 years, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer
- •Inability to follow the treatment and evaluation schedule
- •Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient of interfere with the study objectives
- •Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth-control
- •Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
- •Known hypersensitivity to any of the components of the treatment
- •Pre-existing history of severe lung disease
- •Legal incapacity.
研究者
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