Condition category
Cancer
Date applied
27/03/2017
Date assigned
29/03/2017
Last edited
29/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://inspectgisel.wng.it

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 measures

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

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

http://www.discog.unipd.it/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes