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临床试验/ISRCTN16726595
ISRCTN16726595进行中(未招募)未知

Electrochemotherapy of gynecological cancers

Institute of Oncology Ljubljana0 个研究点目标入组 30 人开始时间: 2020年2月26日最近更新:
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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