Plain English Summary
Background and study aims
Electrochemotherapy (ECT) is a treatment to get chemotherapy into cancer cells. Firstly, a chemotherapy drug (for example, cisplatin or bleomycin) is injected into the tumour. An electric pulse is then applied, altering the outer layer of the cancer cell and making it easier for the drug to enter. ECT is used to control of recurrent or new skin or mucosal cancers in the head and neck region that are not suitable for chemoradiation or surgery. The aim of this study is to test the performance of ECT as an alternative to standard palliative treatments for head and neck cancers. It is hoped that it will work as well as the standard treatments but without as many side effects.
Who can participate?
Adults (aged over 18) with recurrent, metastatic or primary head and neck cancer not suitable for surgery or chemoradiotherapy.
What does the study involve?
Each eligible participant receives an intravenous (i.v.) or intratumoral (i.t.) administration of bleomycin (a drug used for chemotherapy) at a very low dosage and 8 min after the i.v. injection or immediately after the i.t. injection the tumor cells receive an electric stimulation with specific needle electrodes (the process is called electroporation). The procedure can be done under local or general anaesthesia according to the position and the numbers of tumors that have to be treated. The tumor response is investigated after two months and all the patients with complete healing of the lesions have visits at 4, 8 and 12 months after treatment.
What are the possible benefits and risks of participating?
Patients who will partially or totally respond to this treatment are likely to live longer and have a better quality of life (less pain, less bleeding, less anatomical or functional compromise).
Where is the study run from?
This study is run in 6 University or Major Head and Neck Departments in Italy (Pavia), Denmark (Copenhagen), Netherlands (Amsterdam), Spain (Barcelona), UK (London) and Slovenia (Lubljiana).
When is the study starting and how long is it expected to run for?
June 2011 to September 2015
Who is funding the study?
IRCCS Policlinico San Matteo Foundation (Italy)
Who is the main contact?
Dr Giulia Bertino
giulia.bertino@tin.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Giulia Bertino
ORCID ID
http://orcid.org/0000-0003-2840-5184
Contact details
Dept. of Otolaryngology Head & Neck Surgery
University of Pavia
IRCCS Policlinico San Matteo Foundation
P.le Golgi 2
Pavia
27100
Italy
+39 (0)382 526 218
giulia.bertino@tin.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Local treatment of HN cancer by electrochemotherapy. Analysis of the efficacy of the procedure in tumor control and survival
Acronym
EURECA
Study hypothesis
The primary aim is the evaluation of tumor response (one target lesion) according to RECIST criteria (version 1.1) at 2 months follow-up; the secondary aims are the data evaluation about safety (toxicity) of the procedure, analysis of overall and progression free survival and quality of life. In case of execution of PET-CT another secondary aim will be the evaluation of PET-CT uptake change between pre treatment and 8 weeks post treatment.
Ethics approval
Bioethic Committee of the IRCCS Policlinico San Matteo Foundation, 24/11/2011, refs: 20110005216 & P-20110034090
Study design
Phase II observational study
Primary study design
Observational
Secondary study design
Longitudinal 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
Recurrent, metastatic HN cancer or primary cancer in patients with severe co-morbidities and/or which only regular treatment with extensive morbidity is available
Intervention
Collection of the data about tumor response, safety, toxicity, survival and quality of life (QoL) of patients submitted to intravenous administration of 15000 IU BLM/m2 within 1 min, after 8 min electroporation (with Cliniporator and specific electrodes) of the lesion with a 1 cm of safe margin. Procedure has to be finished within 30 min.
4 weeks after procedure:
1. CT or MRI (same imaging as pre-operative evaluation)
2. Evaluation of tumor response in accordance with RECIST criteria (version 1.1)
3. Photographic documentation
4. QOL assessments (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ_5D)
5. In case of residual disease a second ECT can be considered (if residual disease after the 2nd ECT other treatment options must be considered).
8 weeks after procedure:
1. CT or MRI and PET-CT
2. Evaluation of tumor response in accordance with RECIST criteria (version 1.1)
3. Photographic documentation
4. QOL assessments (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ_5D)
5. Biopsy on indication
6. In case of residual disease a second ECT can be considered (if residual disease after the 2nd ECT other treatment options must be considered).
7. All the CR must be followed up at 4, 8, 12 months after treatment
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Evaluation of tumor response (only one target lesion) at 2 months after the procedure
Secondary outcome measures
1. Safety (toxicity) of the procedure
2. Analysis of overall and progression free survival
3. “Quality of life” (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ_5D)
The evaluation of the secondary aims will be performed at each follow-up visit till one year of follow up in case of complete responders or till the last follow up visit before exit the protocol in case of partial responders, stable or progressive disease or death or patient unwilling/unable to continue follow-up.
Overall trial start date
15/06/2011
Overall trial end date
30/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically verified cancer of any type
2. Progressive and/or metastatic disease
3. Primary disease not eligible for surgery for patient’s general conditions or for the need of extensive surgery
4. Patients must have offered standard treatments
5. Measurable lesions suitable for application of electric pulses
6. Age> 18 yrs
7. Performance status (Karnofsky ≥ 70; WHO ≤ 2)
8. Life expectancy> 3 months
9. Treatment free interval of at least 4 weeks after previously applied chemo- or radiotherapyto the target lesions
10. Patients must be mentally capable of understanding the information given and sign informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Other symptomatic lesions not under control
2. Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.)
3. Acute lung infection
4. Symptoms of poor lung function necessitates DLCO and patient can not be treated if this is abnormal
5. Severe coagulation disorders not correctable
6. Previous allergic reactions to bleomycin
7. If cumulative dose of 240000 IU BLM/m2 was previously exceeded
8. Chronic renal dysfunction (creatinine> 150 µmol/L)
9. Pregnancy or lactation
Recruitment start date
01/11/2011
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Denmark, Italy, Netherlands, Slovenia, Spain, United Kingdom
Trial participating centre
Department of Otolaryngology Head & Neck Surgery, University of Pavia, IRCCS Policlinico San Matteo Foundation
P.le Golgi 2
Pavia
27100
Italy
Trial participating centre
Dept. of Otolaryngology, Head and Neck Surgery, VU University Medical Center
Amsterdam
1007 MB
Netherlands
Trial participating centre
Oncologic Service Hospital Clinic
Barcelona
-
Spain
Trial participating centre
Dept. of Oncology, Dept. of Otolaryngology, Head Neck Surgery, Copenhagen University Hospital
Copenhagen
2100
Denmark
Trial participating centre
Dept. of Maxillofacial/Head Neck Surgery Royal Marsden Hospital
London
SW3 6JJ
United Kingdom
Trial participating centre
Dept. of Otolaryngology, University Clinical Center Institute of Oncology
Ljubliana
SI - 1000
Slovenia
Sponsor information
Organisation
IRCCS Policlinico San Matteo Foundation (Italy)
Sponsor details
c/o Prof. Marco Benazzo
Dept. of Otolaryngology Head & Neck Surgery
University of Pavia
IRCCS Policlinico San Matteo Foundation
P.le Golgi 2
Pavia
27100
Italy
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
IRCCS Policlinico San Matteo Foundation (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish results of the EURECA protocol for skin cancer for the end of 2015 and for mucosal cancer for 2016.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27267144