Plain English Summary
Background and study aims
Electrochemotherapy is a cancer treatment. It works though injection of a chemotherapeutic drug (such as bleomycin) and then applying an electric pulse to send the chemotherapy into the cancer cells. Between 70-80% of tumours respond to this treatment. It is currently used for treating skin cancer in 150 centres throughout Europe. The aim of this study is to test how effective and safe electrochemotherapy is in patients with head and neck cancers and measure the concentration of drug bleomycin in the serum (blood) and in the tumour itself.
Who can participate?
Adults (aged over 18) with head or neck cancer, that have not had chemotherapy for at least 2 weeks and are expected to live for more than 3 months.
What does the study involve?
All participants have the electrochemotherapy treatment. The procedure is standardized and is performed according to the published Standard Operating Procedure (SOP) for electrochemotherapy. The chemotherapy drug Bleomycin is injected intravenously (though a needle in a vein) in dose of 15,000 IU/m2. After 8 minutes, electric pulses are delivered to the tumour in order to send the bleomycon into the cancer cells. The response of the tumour to the treatment is assessed at one month and again at two months.
What are the possible benefits and risks of participating?
So far minimal or no side effects have been reported. Due to the pain caused by the electric pulses, local or general anaesthesia will be needed. There may be some reddening of the skin but no pain after the treatment is complete is expected.
Where is the study run from?
The University Medical Centre Ljubljana and Institute of Oncology Ljubljana (Slovenia)
When is the study starting and how long is it expected to run for?
July 2015 to December 2017
Who is funding the study?
Slovenian Research Agency
Who is the main contact?
1. Professor Gregor Sersa (scientific)
gsersa@onko-i.si
2. Mr Ales Groslj (public)
ales.groselj@kclj.si
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gregor Sersa
ORCID ID
http://orcid.org/0000-0002-7641-5670
Contact details
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
+386 1/5879434
gsersa@onko-i.si
Type
Scientific
Additional contact
Mr Ales Groselj
ORCID ID
Contact details
Department of Otorhinolaryngology and Cervicofacial Surgery
University Medical Centre Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
+38615222153
ales.groselj@kclj.si
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficiency of electrochemotherapy in treatment of head and neck cancer: a multicentre, interventional study
Acronym
NECT
Study hypothesis
The aim of the study is to evaluate the efficacy and safety of electrochemotherapy with bleomycin and improvement of therapeutic procedures in patients with cancer in head and neck region treated with electrochemotherapy.
Ethics approval
Republic of Slovenia National Ethics Committee, 23/06/2015, ref: KME 058/06/15
Study design
Multicentre interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Cancer in the head and neck region
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 measures
Setting a time frame of optimal concentration of bleomycin in tumors and plasma for effective electrochemotherapy treatment.
Overall trial start date
01/07/2015
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/07/2015
Recruitment end date
30/09/2017
Locations
Countries of recruitment
Slovenia
Trial participating centre
Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
Trial participating centre
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
Sponsor information
Organisation
Clinic of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana
Sponsor details
Zaloska 2
Ljubljana
1000
Slovenia
Sponsor type
Hospital/treatment centre
Website
Organisation
Institute of Oncology Ljubljana
Sponsor details
Zaloska 2
Ljubljana
1000
Slovenia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Javna Agencija za Raziskovalno Dejavnost RS
Alternative name(s)
Slovenian Research Agency, ARRS
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Slovenia
Results and Publications
Publication and dissemination plan
1. Pharmacological study will be performed in order to determine the optimal therapeutic window for electrochemotherapy (article in preparation)
2. Clinical response data will be collected and analysed, for evaluation of the therapeutic effectiveness of electrochemotherapy in patients with cancer in head and neck region. (article will be prepared at the end of the study)
3. The data of the bleomycin content in tumours at the time of electrochemotherapy will be correlated with the treatment outcome. (article will be prepared at the beginning of 2017)
Intention to publish date
31/12/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list