Efficiency of electrochemotherapy in treatment of head and neck cancer: a multicentre, interventional study

jubljana University Medical Centre0 个研究点目标入组 78 人开始时间: 2016年1月7日最近更新: 2022年10月31日

适应症

试验速览

•1. Histologicaly or citologicaly confirmed carcinoma and/or recurrent disease and/or multiple nodules on different sites and/or tumors that require reconstruction with the local and / or remote lobes and/or tumors located at the sites where after excision poor aesthetic outcome is expected and/or patients who refuse other treatment options
•2. Age over 18
•3. The life expectancy more than 3 months
•4. Performance status Karnofsky = 70 or (World Health Organization) WHO = 2
•5. Chemotherapy free interval at least 2 weeks
•6. Patient must be mentally capable of understanding the information given
•7. Patient must give informed consent
•8. Patient must be discussed at the multidisciplinary team

•1. Lesions which are not suitable for treatment with electrochemotherapy (invasion into the bone, infiltration of large vessels)
•2. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies
•3. Significant reduction in respiratory function
•4. Age less than 18 years
•5. Coagulation disturbances
•6. Cumulative dose of 250 mg/m2 bleomycin received
•7. Allergic reaction to bleomycin
•8. Impaired kidney function (creatinin > 150 µmol/l)
•9. Patients with epilepsy
•10. Pregnancy
•11. Patients incapable to understand the aim of the study or those who do not agree with the inclusion

发起方

jubljana University Medical Centre