Efficiency of electrochemotherapy in treatment of head and neck cancer

• Register: ISRCTN
• Last refreshed on: 31 October 2022
• Main ID: ISRCTN37372189
• Date of registration: 07/01/2016
• Prospective Registration: No
• Primary sponsor: Ljubljana University Medical Centre
• Public title: Efficiency of electrochemotherapy in treatment of head and neck cancer
• Scientific title: Efficiency of electrochemotherapy in treatment of head and neck cancer: a multicentre, interventional study
• Date of first enrolment: 01/07/2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN37372189
• Study type: Interventional
• Study design: Multicentre interventional study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Slovenia

Contacts

• Name: Gregor Sersa

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer in the head and neck region
Cancer
Head and neck

Intervention(s)

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 15,000 IU/m2 skin surface. The electric pulses will be delivered by electrodes to the tumors generated by electric pulse generator Cliniporator (IGEA, Carpi, Italy) 8-28 minutes after bleomycin injection. During the procedure tumor tissue and blood samples will be collected for the purpose of pharmacological analysis. Patients will be followed up at 1, 2, 4, 8, 12, 18 and 24 months after the treatment.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Javna Agencija za Raziskovalno Dejavnost RS

Secondary Sponsor(s)

Institute of Oncology Ljubljana

Ethics review

Status:
Approval date:
Contact:

Republic of Slovenia National Ethics Committee, 23/06/2015, ref: KME 058/06/15

Results

• Results available: Yes
• Date Completed: 31/12/2017