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
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