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Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II

NCT02352259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-03-24

Study results available
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Summary

The study is prospective, phase II study, The primary objective of the study is evaluation of the feasibility and safety of intraoperative electrochemotherapy of colorectal liver metastases. The secondary objective is to determine the efficacy of electrochemotherapy treatment, based on histological and radiological evaluation of treated metastases. The endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST criteria.

Conditions

  • Liver Metastases

Interventions

PROCEDURE

Electrochemotherapy

Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin, within 8-30 min after administration of bleomycin application of electric pulses, removal of electrodes.

DEVICE

Cliniporator Vitae®

Positioning of electrodes, within 8-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.

DRUG

Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Intravenous in bolus administration of bleomycin (15 mg/m2), 8 minutes before application of electric pulses

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    collaborator OTHER

  • University Medical Centre Maribor

    collaborator OTHER

  • University of Ljubljana

    collaborator OTHER

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Gregor Sersa, PhD · Institute of Oncology Ljubljana, Ljubljana, Slovenia

  • Ibrahim Edhemovic, MD, PhD · Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352259 on ClinicalTrials.gov