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Treatment of Liver Metastases With Electrochemotherapy

NCT01264952 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-11-24

Study results available
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Summary

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I and II.

The study will include 10-15 patients with colorectal cancer with synchronous or metachronous liver metastases, but electrochemotherapy will be performed on metastasis not more than 3 cm in the largest diameter.

Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and ultrasonography (US) in a monthly interval. Two or three month after the first operation the treated and untreated metastases will be resected and through histological analyses performed.

The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.

Conditions

  • Liver Metastases

Interventions

PROCEDURE

Electrochemotherapy

Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin (15 mg/m2), within 5-30 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. The maximum duration of procedure is 90 minutes.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    collaborator OTHER

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Eldar Gadzijev, MD, PhD · Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia

  • Gregor Sersa, PhD (Biol.) · Institute of Oncology Ljubljana, Department of Experimental 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
2008-11-30
Primary Completion
2013-03-31
Completion
2013-11-30

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 NCT01264952 on ClinicalTrials.gov