Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352259
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
University Medical Centre Ljubljana
University Medical Centre Maribor
University of Ljubljana
Information provided by (Responsible Party):
Institute of Oncology Ljubljana

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.

Condition or disease Intervention/treatment Phase
Liver Metastases Procedure: Electrochemotherapy Device: Cliniporator Vitae® Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Study Start Date : September 2013
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Evaluation of safety related to electrochemotherapy (according to CATCE criteria) [ Time Frame: After operation on day 7 ]
    Biochemistry, blood test


Secondary Outcome Measures :
  1. Changes is clinical response- Number of Adverse events [ Time Frame: After operation on the days 2, 7, 30 ]
    Biochemistry, blood test, CT

  2. Response to treatment (determined by Modified RECIST criteria). [ Time Frame: After operation on the days 30, 60, 90 and 120 ]
    Imaging methods for the evaluation of the treated lesions in the liver.

  3. Changes in quality of life [ Time Frame: After operation on the days 7 and 30 ]
    EORTC QLQ30



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352259


Locations
Layout table for location information
Slovenia
Faculty of Electrical Engineering, University of Ljubljana, Slovenia
Ljubljana, Slovenia, 1000
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
University Medical Centre Ljubljana, Ljubljana, Slovenia
Ljubljana, Slovenia, 1000
University Medical Centre Maribor, Maribor, Slovenia
Maribor, Slovenia, 2000
Sponsors and Collaborators
Institute of Oncology Ljubljana
University Medical Centre Ljubljana
University Medical Centre Maribor
University of Ljubljana
Investigators
Layout table for investigator information
Study Director: Gregor Sersa, PhD Institute of Oncology Ljubljana, Ljubljana, Slovenia
Principal Investigator: Ibrahim Edhemovic, MD, PhD Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia
Publications:
Layout table for additonal information
Responsible Party: Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier: NCT02352259    
Other Study ID Numbers: 03-Z/KESOPKR-28
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Keywords provided by Institute of Oncology Ljubljana:
Liver metastases of colorectal cancer Electrochemotherapy
Bleomycin
Electrochemotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents