ISRCTN16726595进行中(未招募)未知
Electrochemotherapy of gynecological cancers
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Local or regional recurrences of gynecologic tumors in which standard treatment has been exhausted
- •2. Age over 18 years
- •3. Life expectancy of more than 3 months
- •4. Karnofsky body capacity = 70 or 5. At least 2 weeks have elapsed since the last possible treatment
- •6. The patient should be able to understand the treatment process and any side effects that may occur with the treatment
- •7. The patient must be able to sign inform consent to participate in the clinical study
- •8. Before entering the study, the patient must be presented at the multidisciplinary board
- •9. Suitable for procedures in anesthesia
排除标准
- •1. Lesions not suitable for treatment with electrochemotherapy (invasion of bone, infiltration of large vessels)
- •2. A life-threatening infection and/or heart failure and/or liver failure and/or other threatening systemic diseases
- •3. A significant decline in lung function that requires DLCO determination. We are not allowed to treat patients if DLCO is abnormal
- •4. Age under 18 years
- •5. Major disruptions in the coagulation system (which do not respond to the standard therapy – supplementation of vitamin K or freshly frozen plasma)
- •6. A previously received cumulative dose of bleomycin= 400 mg / m²
- •7. A chronic decline in the kidney function (creatinine > 150 µmol/L)
- •8. Epilepsy
- •9. Pregnancy
- •10. The patients’ uncapatibily of comprehending the purpose or course of the trial, or not agreeing to be included in the trial
研究者
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