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临床试验/DRKS00034205
DRKS00034205招募中不适用

Registry to collect clinical data on the effect and symptom control of electrochemotherapy for head and neck tumors

niversitätsklinikum Jena, Klinik für Hals-, Nasen- und Ohrenheilkunde0 个研究点目标入组 150 人开始时间: 2024年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150

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

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • ? Histologically confirmed malignant neoplasm of any kind
  • ? Progressive and / or metastatic disease or
  • ? Primary disease that is not suitable for surgery due to the patient's general condition or the need for a very extensive surgical procedure or
  • ? Patient refuses standard treatments or provides written informed consent. Inclusion is possible if the patient refuses another form of standard treatment. Patient gives written consent for treatment with electrochemotherapy.
  • ? Measurable lesions that are suitable for the application of electrical impulses
  • ? Treatment-free interval of at least 4 weeks after previous chemotherapy or radiotherapy of the target lesions
  • ? Patients must be mentally capable of understanding the information and signing the consent form

排除标准

  • ? Patients with symptomatic or rapidly progressive metastases outside the ENT area
  • ? Presence of lesions that are not indicated for treatment with ECT (bony infiltration, infiltration of large vessels, etc.)
  • ? Acute pneumonia
  • ? Pulmonary dysfunction
  • ? Unrecoverable severe coagulation disorders
  • ? Previous allergic reactions to bleomycin
  • ? Cumulative dose of 240,000 IU BLM/m² was previously exceeded
  • ? Chronic renal dysfunction (creatinine > 150 µmol/L)
  • ? Pregnancy or breastfeeding

研究者

发起方
niversitätsklinikum Jena, Klinik für Hals-, Nasen- und Ohrenheilkunde

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