Treatment of Liver Metastases With Electrochemotherapy (ECTJ)

This study has been completed.
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier:
NCT01264952
First received: December 15, 2010
Last updated: December 19, 2014
Last verified: December 2014
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Metastases
Intervention: Procedure: Electrochemotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group I The first group included patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
Group II The second group (group II) included patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
Group III The third group included patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.

Participant Flow:   Overall Study
    Group I     Group II     Group III  
STARTED     6     2     8  
COMPLETED     6     2     8  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group I Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
Group II Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
Group III Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
Total Total of all reporting groups

Baseline Measures
    Group I     Group II     Group III     Total  
Number of Participants  
[units: participants]
  6     2     8     16  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     2     7     12  
>=65 years     3     0     1     4  
Age  
[units: years]
Median (Standard Deviation)
  60.0  (6.4)     45.5  (19.1)     57.3  (10.7)     56.8  (10.6)  
Gender  
[units: participants]
       
Female     1     0     3     4  
Male     5     2     5     12  
Region of Enrollment  
[units: participants]
       
Slovenia     6     2     8     16  



  Outcome Measures
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1.  Primary:   Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)   [ Time Frame: After operation on day 7 ]

2.  Secondary:   Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment)   [ Time Frame: After operation on tha days 2, 7, 30, monthly ]

3.  Secondary:   Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology   [ Time Frame: After operation or 1st day after operation, 7th day, 30th day, monthly ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gregor Sersa, PhD
Organization: Institute of Oncology Ljubljana
phone: +386 1 5879 434
e-mail: gsersa@onko-i.si


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier: NCT01264952     History of Changes
Other Study ID Numbers: 03-Z 16/KSOPKR-6
Study First Received: December 15, 2010
Results First Received: December 19, 2014
Last Updated: December 19, 2014
Health Authority: Slovenia: Ethics Committee