Efficiency of electrochemotherapy in treatment of head and neck cancer

ISRCTN ISRCTN37372189
DOI https://doi.org/10.1186/ISRCTN37372189
Secondary identifying numbers N/A
Submission date
04/01/2016
Registration date
07/01/2016
Last edited
18/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Gregor Sersa
Scientific

Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

ORCiD logoORCID ID 0000-0002-7641-5670
Phone +386 1/5879434
Email gsersa@onko-i.si
Mr Ales Groselj
Scientific

Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

Phone +38615222153
Email ales.groselj@kclj.si

Study information

Study designMulticentre interventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEfficiency of electrochemotherapy in treatment of head and neck cancer: a multicentre, interventional study
Study acronymNECT
Study objectivesThe 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(s)Republic of Slovenia National Ethics Committee, 23/06/2015, ref: KME 058/06/15
Health condition(s) or problem(s) studiedCancer in the head and neck region
InterventionAll 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 typeProcedure/Surgery
Primary outcome measure1. 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 measuresSetting a time frame of optimal concentration of bleomycin in tumors and plasma for effective electrochemotherapy treatment.
Overall study start date01/07/2015
Completion date31/12/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Total final enrolment78
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/07/2015
Date of final enrolment30/09/2017

Locations

Countries of recruitment

  • Slovenia

Study participating centres

Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Ljubljana University Medical Centre
Hospital/treatment centre

Clinic of Otorhinolaryngology and Cervicofacial Surgery
Zaloska 2
Ljubljana
1000
Slovenia

Website http://www.kclj.si/
ROR logo "ROR" https://ror.org/01nr6fy72
Institute of Oncology Ljubljana
Hospital/treatment centre

Zaloska 2
Ljubljana
1000
Slovenia

Funders

Funder type

Government

Javna Agencija za Raziskovalno Dejavnost RS
Government organisation / National government
Alternative name(s)
Slovenian Research Agency, Javna agencija za raziskovalno dejavnost RS v angleškem jeziku: Slovenian Research Agency, Javna Agencija za Raziskovalno Dejavnost RS, The Slovenian Research and Innovation Agency (ARIS), Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije, ARRS, ARIS
Location
Slovenia

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination plan1. 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)
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available. The data will be held in an institutional electrochemistry database.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2016 Yes No
Protocol file 30/08/2022 No No
Protocol file 30/08/2022 No No

Additional files

ISRCTN37372189_PROTOCOL.pdf
ISRCTN37372189_PROTOCOL_Slovenian.pdf

Editorial Notes

18/10/2022: Total final enrolment and IPD sharing statement added.
30/08/2022: Protocol files uploaded.
11/12/2018: Publication reference added.
18/10/2017: Internal review.