Condition category
Cancer
Date applied
04/01/2016
Date assigned
07/01/2016
Last edited
06/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
+3861 5879 434
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 measures

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

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes