Plain English Summary
Background and study aims
Electrochemotherapy (ECT) is a safe skin-directed treatment for cancer which combines drug treatment with short electric pulses to the tumor. The procedure lasts 20-40 minutes and is generally performed under sedation. It generally allows for a fast recovery with low discomfort. The aims of this study are to find out how well ECT works in patients with breast cancer that has spread to the skin (cutaneous metastases), and to find out which patients have the best response to the treatment.
Who can participate?
Women (men can be also included) with skin metastases from breast cancer who are not suitable candidates for surgery, radiotherapy or systemic treatments
What does the study involve?
All participants receive ECT treatment according to routine clinical practice under general sedation or local anaesthetic, according to the amount of tumor. The patients have to stay in hospital 4-6 hours after the procedure or until the following day, according to their general conditions and specific requirements. After discharge, the patients attend outpatient clinics for regular clinical examination of treated tumors. They are asked to answer to some brief questionnaires regarding their quality of life and symptoms related to skin metastases.
What are the possible benefits and risks of participating?
Taking part in this study can have many benefits for breast cancer patients with skin metastases. Participants have the support of an experienced team of health care providers, who closely monitor the tumor response to ECT, its possible side effects as well as the disease course. Collecting information about other cancer treatments given before or after ECT could help with finding new effective treatment strategies. Finally, the information gathered will help to gain insights into patient quality of life and to improve the overall treatment of other patients with skin metastases. There are no specific risks related to this study, as the treatment is part of routine clinical practice. As such, it is expected that patients may have local side effects (skin toxicity) and, very rarely, systemic side effects (fever, lung toxicity) from the ECT treatment.
Where is the study run from?
This study is being run by the Italian Senologic Group for Electrochemotherapy (GISEL) and takes place in several hospitals across Italy.
When is the study starting and how long is it expected to run for?
April 2016 to October 2021
Who is funding the study?
Associazione Piccoli Punti Onlus (Italy)
Who is the main contact?
Dr Luca G. Campana
luca.campana@iov.veneto.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Luca Giovanni Campana
ORCID ID
http://orcid.org/0000-0002-8466-8459
Contact details
Veneto Institute of Oncology IOV-IRCCS
Via Gattamelata
64
Padova
35128
Italy
+39 (0)49 821 5526
luca.campana@iov.veneto.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
GISEL (Gruppo Italiano Senologico per l'ELettrochemioterapia) protocol: prospective multicenter registry of breast cancer patients with skin metastases treated by electrochemotherapy
Acronym
GISEL (Italian Senologic Group for Electrochemotherapy)
Study hypothesis
The primary objective of the study is to confirm the results obtained in the previous multicenter retrospective study from the GISEL group. In that study, the breast cancer patients with "luminal A-like" disease who underwent electrochemotherapy with bleomycin achieved a significantly higher complete response rate compared with other surrogate subtypes, defined according to the St. Gallen classification. (73.9% vs 54.7%, P = 0.02). In the present study the trialists intend to verify, on a large perspective series, if the rate of complete response in patients with “luminal A-like" breast cancer is significantly higher than in other subgroups.
Ethics approval
Veneto Institute of Oncology, Padova, Italy; Ethics Committee for Clinical Trial (Istituto Oncologico Veneto IOV-IRCCS, Padova; Comitato Etico per la Sperimentazione Clinica (CESC)), 20/02/2017, ref: CE IOV: 2017/11
Study design
Prospective multicenter observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available
Condition
Cutaneous metastases from breast cancer
Intervention
Patients will be enrolled based on the inclusion criteria currently employed in the clinical practice. The percentage of women with "luminal A-like" breast cancer in the previous, retrospective study was 18.4%. The trialists hypothesize to have the same patient distribution in the present study. In order to test the hypothesis of a significant difference between “luminal A-like” tumors and the other surrogate subtypes with a statistical power of 90% and a significance level of 5%, some 351 patients are required (64 in the "A luminal-like" group and 287 in the group non-"luminal A-like"). Taking into account also a 15% patient dropout, it is necessary to recruit a study population of 404 patients.
All patients will receive treatment with electrochemotherapy according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE). Participating in this study involves receiving treatment with ECT under general sedation or local anaesthesia, according to the amount of skin tumor involvement; the patients will have to stay in hospital 4-6 hours after the procedure or until the following day, according to their general conditions and specific requirements. After discharge, the patients will attend the outpatient clinics for regular clinical examination of treated tumors. They will be asked to answer to some brief questionnaires regarding their quality of life and symptoms related to skin metastases. The planned follow-up time planned for each patient is 12 months leading to a total study duration of four years. After the fourth year, the database could be maintained open to further accrual in the event of insufficient patient accrual or if, based on collected data, additional research questions arise.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Local response to the treatment, assessed using clinical examination and graded according to the Response Evaluation Criteria In Solid Tumors (RECIST) at 4 and 8 weeks
2. Treatment toxicity, assessed using clinical examination and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) at 1 and 2 weeks and 1, 2, 3, 6 and 12 months
Secondary outcome measures
1. Local progression-free survival (LPFS), assessed using physical examination at 1, 2 , 3 , 6 and 12 months (and every 6 months thereafter)
2. Quality of life, measured using the EQ-5D questionnaire at 1 and 2 weeks, and at 1, 2, 3, 6 and 12 months
Overall trial start date
22/04/2016
Overall trial end date
21/10/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Cutaneous metastases from breast cancer
2. No indication to surgical resection
3. No indication to treatment with radiotherapy
4. Ineligibility or unresponsiveness to systemic cancer treatment
5. Maximum tumor depth (from the skin layer): 3 cm
6. Patient's life expectancy greater than 4 months
7. Normal hematology, hepatic and renal function
8. Performance status (ECOG) ≤2
9. At least 18 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
404
Participant exclusion criteria
1. History of allergic reaction to bleomycin
2. Exceeding the maximum cumulative dose of bleomycin (250,000 IU / m2)
3. Severe impairment of lung, liver or kidney function
4. History of epilepsy
5. Presence of a cardiac pacemaker
6. Serious cardiac arrhythmias
7. Pregnancy or lactation
8. Unwillingness to attend the clinic for follow-up visits
9. Impaired respiratory function or presence of pulmonary fibrosis
Recruitment start date
06/03/2017
Recruitment end date
06/03/2021
Locations
Countries of recruitment
Italy
Trial participating centre
Veneto Institute of Oncology IOV-IRCCS
Padova
35128
Italy
Trial participating centre
University of Naples
Naples
80138
Italy
Trial participating centre
Ospedale Sant'Orsola-Malpighi
Bologna
40138
Italy
Trial participating centre
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milano
20133
Italy
Trial participating centre
IRCCS San Martino-IST
Genova
16132
Italy
Trial participating centre
Fondazione Tommaso Campanella
Catanzaro
88100
Italy
Trial participating centre
Istituto Tumori "Giovanni Paolo II"
Bari
70124
Italy
Trial participating centre
IRCCS CROB
Rionero in Vulture
85028
Italy
Trial participating centre
Istituto Dermatologico San Gallicano
Roma
00144
Italy
Trial participating centre
Istituto Tumori Napoli - Fondazione G. Pascale
Naples
80131
Italy
Trial participating centre
Ospedale Oncologico Armando Businco
Cagliari
09121
Italy
Trial participating centre
A.O.U. Citta della Salute e della Scienza di Torino
Torino
10126
Italy
Trial participating centre
Policlinico Umberto I - Università La Sapienza
Rome
00161
Italy
Trial participating centre
Humanitas Centro Catanese di Oncologia
Catania
95126
Italy
Sponsor information
Organisation
Veneto Institute of Oncology IOv-IRCCS
Sponsor details
Surgical Oncology Unit
Via Gattamelata
64
Padova
35128
Italy
Sponsor type
Hospital/treatment centre
Website
Organisation
University of Padova
Sponsor details
Department of Surgery Oncology and Gastroenterology
Via Giustiniani
2
Padova
35128
Italy
+39 (0)49 8214397
dipartimento.discog@pec.unipd.it
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Associazione Piccoli Punti Onlus (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of this study will be presented as a research article and submitted to a high-impact peer reviewed journal.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Luca G. Campana (luca.campana@unipd.it or luca.campana@iov.veneto.it).
Intention to publish date
15/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list