Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II

NCT02352259 | Completed Phase 2 Results DMC

• 1 other identifier: 03-Z/KESOPKR-28
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Liver metastases of colorectal cancer Electrochemotherapy; Bleomycin; Electrochemotherapy

Outcome Measures

Primary Outcomes (1)

• Evaluation of Safety Related to Electrochemotherapy

  Recording of adverse events according to CTCAE criteria

  After operation on day 7

Secondary Outcomes (1)

• Response to Treatment (Determined by Modified RECIST Criteria).

  After operation on the days 30, 60, 90 and 120

Study Arms (1)

Electrochemotherapy

EXPERIMENTAL

Procedure: Electrochemotherapy; Device: Cliniporator Vitae®; Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Interventions

Electrochemotherapy PROCEDURE

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.

Electrochemotherapy

Cliniporator Vitae® DEVICE

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.

Electrochemotherapy

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

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

Electrochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and/or cytologically confirmed colorectal cancer.
• Age over 18.
• Life expectancy more than 3 month.
• Performance status Karnofsky ≥ 70 or (World Health Organization) WHO ≤ 2.
• Chemotherapy free interval 2-5 weeks, depending on the drugs used.
• Patient must be mentally capable of understanding the information given.
• Patient must give informed consent.
• Patient must be discussed at the multidisciplinary team for tumors of the gastrointestinal tract before entering the trial.

You may not qualify if:

• Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma
• Visceral, bone or diffuse metastases.
• Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
• Clinically significant ascites.
• Significant reduction in respiratory function.
• Age less than 18 years.
• Coagulation disturbances.
• Cumulative dose of 250 mg/m2 bleomycin received.
• Allergic reaction to bleomycin.
• Impaired kidney function (creatinin \> 150 µmol/l).
• Patients with epilepsy.
• Patients with arrhythmias.
• Patients with pacemaker or defibrillator.
• Pregnancy.
• Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead
• University Medical Centre Ljubljana: collaborator
• University Medical Centre Maribor: collaborator
• University of Ljubljana: collaborator

Study Sites (4)

Faculty of Electrical Engineering, University of Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

University Medical Centre Maribor, Maribor, Slovenia

Maribor, 2000, Slovenia

Location

Related Publications (2)

• Edhemovic I, Brecelj E, Gasljevic G, Marolt Music M, Gorjup V, Mali B, Jarm T, Kos B, Pavliha D, Grcar Kuzmanov B, Cemazar M, Snoj M, Miklavcic D, Gadzijev EM, Sersa G. Intraoperative electrochemotherapy of colorectal liver metastases. J Surg Oncol. 2014 Sep;110(3):320-7. doi: 10.1002/jso.23625. Epub 2014 Apr 30.

  PMID: 24782355 BACKGROUND

• Edhemovic I, Gadzijev EM, Brecelj E, Miklavcic D, Kos B, Zupanic A, Mali B, Jarm T, Pavliha D, Marcan M, Gasljevic G, Gorjup V, Music M, Vavpotic TP, Cemazar M, Snoj M, Sersa G. Electrochemotherapy: a new technological approach in treatment of metastases in the liver. Technol Cancer Res Treat. 2011 Oct;10(5):475-85. doi: 10.7785/tcrt.2012.500224.

  PMID: 21895032 BACKGROUND

MeSH Terms

Interventions

Electrochemotherapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Results Point of Contact

• Title: Dr Gregor Serša
• Organization: Institute of Oncology Ljubljana

gsersa@onko-i.si

+38615874343

Study Officials

• Gregor Sersa, PhD

  Institute of Oncology Ljubljana, Ljubljana, Slovenia

  STUDY DIRECTOR

• Ibrahim Edhemovic, MD, PhD

  Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: February 2, 2015
• Study Start: September 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Locations

SL (4)