CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 205 enrolled
Drug / intervention
Bleomycin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06683404
NCT06683404N/ACompleted

GISEL (Italian Senologic Group for Electrochemotherapy): Prospective Multicenter Registry of Breast Cancer Patients With Skin Metastases Treated by Electrochemotherapy

Istituto Oncologico Veneto IRCCS·observational·Posted Nov 12, 2024·Updated Nov 12, 2024

In Brief

An observational study evaluating Electrochemotherapy (ECT) and Bleomycin for Breast Cancer and 2 related conditions. Completed, enrolled 205 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 12, 2024
Enrollment StartApr 22, 2016
Primary CompletionOct 21, 2021
Study CompletionDec 10, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 1.6 years ago

Interventions

Electrochemotherapy (ECT)device

Electrochemotherapy (ECT) is characterized by the association between the administration of a chemotherapic agent (Bleomycin) with the temporary raise of permeability of the cellular membrane induced by the local administration of electrical impulses (electroporation). ECT represents an effective therapy for loco-regional control of this disease.

Bleomycindrug

Electrochemotherapy (ECT) is characterized by the association between the administration of a chemotherapic agent (Bleomycin) with the temporary raise of permeability of the cellular membrane