EUCTR2009-011455-51-DK进行中（未招募）不适用
Palliative treatment of ulcerated cutaneous metastases: Randomised trial between electrochemotherapy and radiotherapy
Department of Oncology, University Hospital Herlev0 个研究点开始时间: 2009年4月16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
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
- •1)Age = 18 years
- •2)Histological proven cancer
- •3)Progressive and/or metastatic disease
- •4)One or more ulcerated cutaneous lessions
- •5)Patient need for palliative tretment for the cutaneous lession(s)
- •6)Target lession = 1 cm and = 5 cm, max 5 target lessions
- •7)The cutaneous lession(s) must be stationary or progressive if the patient at the same time is treated with chemotherapy.
- •8)WHO performancestatus = 2
- •9)Life expectancy =3 months
- •10)Platelets = 50 mia/l, pp = 40, APTT in normal area. Medical correction is alloved.
- •11)Sexually active men and women in the reproductive age must use safe anticonception during and up to 6 months after treatment.
- •12)Written informed consent must be obtained according to the local Ethics Commitee 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
- •1)Previous electrochemotherapy or radiotherapy of the target area
- •2)Acute lunginfection
- •3)Previous bleomycin treatment exceeding 200.000 Units/m2
- •4)Known hypersensitivity to any of the components of the treatment
- •5)Known hypersensitivity to any of the components used in the planned anaesthesia
- •6)Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood.
- •7)Treatment with granulocyt colony stimulating factor (G-CSF) or other cytokines.
- •8)If creatinin is over 150 mikromolær, glomerular filtration rate must be investigated by Crom-EDTA-clearance. If Crom-EDTA-clearance < 48 ml/min the patient can not be offered treatment in the protocol.
- •9)Lungdiffusion kapacity (DLCO test) under the normal area. DLCO test is carried out if clinical or anamnestic suspicion of reduced lungkapacity.
研究者
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