EUCTR2010-022924-57-SE进行中（未招募）1 期
Randomised phase II study with cetuximab (Erbitux®) in combination with 5-FU and cisplatin or carboplatin versus cetuximab (Erbitux®) in combination with paclitaxel and carboplatin for treatment of patients with relapsed or metastatic squamous cell carcinoma of the head and neck - CETMET
Radiumhemmet Karolinska University Hospital0 个研究点目标入组 120 人开始时间: 2011年7月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •? > 18 years
- •? Histologically or cytologically confirmed SCCHN, relapsed and/or metastatic
- •Patient must have a life expectancy of at least 3 months allowing adequate follow-up toxicity evaluation.
- •At least 1 dimensionally measurable lesion either by CT scan or MRI or physical examination. PS WHO 0-1 at study entry
- •Adequate hematological function defined as WBC =3 x 109/litre and platelets =100 x 109/litre, ANC > 1.5 x 109/litre and Hb > 100 g/L
- •Adequate liver function: Bilirubin <1.5 x UNL, ALAT or ASAT <3,0 UNL, alkaline phosphates < 2.5 UNL
- •Creatinine clearance > 50mL/min when treated with Cisplatin
- •Written informed consent must be obtained according to the local Ethics committee.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Nasopharyngeal ca, and cancer of the paranasal sinuses
- •Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient or 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 any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment.
- •Legal incapacity.
- •Clinically significant cardiovascular disease, , or history of myocardial infarction in the last 6 months.
- •Patients with clinically relevant neuropathy
- •Previously treated for relapsed or metastatic SCCHN except radiotherapy
- •Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry
研究者
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Randomised phase II study with cetuximab (Erbitux®) in combination with 5-FU and cisplatin or carboplatin versus CETuximab (Erbitux®) in combination with paclitaxel and carboplatin for treatment of patients with relapsed or METastatic squamous cell carcinoma of the head and neck - CETMETPatients with metastatic or recurrent squamous cell carcinoma of the head and neck, not suitable for local treatmentMedDRA version: 19.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022924-57-DKRadiumhemmet, Karolinska University Hospital, Stockholm, Sweden120
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