Cancer in the head and neck region Cancer Head and neck
Conditions
Interventions
All patients are treated with electrochemotherapy with bleomycin, according to European Standard Operating Procedures of Electrochemotherapy. Bleomycin will be injected intravenously in a dose of 15,0
Sponsors
Ljubljana University Medical Centre
Institute of Oncology Ljubljana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Antitumor efficiency of electrochemotherapy, evaluated by measurement of tumor response in accordance with RECIST criteria, 1 and 2 months after the treatment 2. Safety of electrochemotherapy. Any adverse events will be recorded according to National Cancer Institute (NCI) criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Setting a time frame of optimal concentration of bleomycin in tumors and plasma for effective electrochemotherapy treatment. | — |
Countries
Slovenia
Outcome results
None listed