Efficiency of electrochemotherapy in treatment of head and neck cancer

Not Applicable

Completed

• Conditions: Cancer in the head and neck region; Cancer; Head and neck

• Registration Number: ISRCTN37372189
• Lead Sponsor: jubljana University Medical Centre

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26992379 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-07
• Study Completion: 2017-12-31
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Antitumor efficiency of electrochemotherapy, evaluated by measurement of tumor response in accordance with RECIST criteria, 1 and 2 months after the treatment<br> 2. Safety of electrochemotherapy. Any adverse events will be recorded according to National Cancer Institute (NCI) criteria<br>

Secondary Outcome Measures

Name	Time	Method
Setting a time frame of optimal concentration of bleomycin in tumors and plasma for effective electrochemotherapy treatment.