ISRCTN78463063已完成不适用
ocal treatment of HN cancer by electrochemotherapy. Analysis of the efficacy of the procedure in tumor control and survival
IRCCS Policlinico San Matteo Foundation (Italy)0 个研究点目标入组 120 人开始时间: 2015年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- Observational
入排标准
- 性别
- All
入选标准
- •1. Histologically verified cancer of any type
- •2. Progressive and/or metastatic disease
- •3. Primary disease not eligible for surgery for patient’s general conditions or for the need of extensive surgery
- •4. Patients must have offered standard treatments
- •5. Measurable lesions suitable for application of electric pulses
- •6. Age> 18 yrs
- •7. Performance status (Karnofsky = 70; WHO = 2)
- •8. Life expectancy> 3 months
- •9. Treatment free interval of at least 4 weeks after previously applied chemo- or radiotherapyto the target lesions
- •10. Patients must be mentally capable of understanding the information given and sign informed consent
排除标准
- •1. Other symptomatic lesions not under control
- •2. Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.)
- •3. Acute lung infection
- •4. Symptoms of poor lung function necessitates DLCO and patient can not be treated if this is abnormal
- •5. Severe coagulation disorders not correctable
- •6. Previous allergic reactions to bleomycin
- •7. If cumulative dose of 240000 IU BLM/m2 was previously exceeded
- •8. Chronic renal dysfunction (creatinine> 150 µmol/L)
- •9. Pregnancy or lactation
研究者
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