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Treatment of Liver Metastases With Electrochemotherapy (ECTJ)

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ClinicalTrials.gov Identifier: NCT01264952
Recruitment Status : Completed
First Posted : December 22, 2010
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Institute of Oncology Ljubljana

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Metastases
Intervention Procedure: Electrochemotherapy
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 6 2 8
Completed 6 2 8
Not Completed 0 0 0
Arm/Group Title Group I Group II Group III Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 6 2 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  50.0%
2
 100.0%
7
  87.5%
12
  75.0%
>=65 years
3
  50.0%
0
   0.0%
1
  12.5%
4
  25.0%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 2 participants 8 participants 16 participants
60.0  (6.4) 45.5  (19.1) 57.3  (10.7) 56.8  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 8 participants 16 participants
Female
1
  16.7%
0
   0.0%
3
  37.5%
4
  25.0%
Male
5
  83.3%
2
 100.0%
5
  62.5%
12
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovenia Number Analyzed 6 participants 2 participants 8 participants 16 participants
6 2 8 16
1.Primary Outcome
Title Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)
Hide Description [Not Specified]
Time Frame After operation on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 6 2 8
Measure Type: Number
Unit of Measure: Toxicity, symptoms
0 0 0
2.Secondary Outcome
Title Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment)
Hide Description [Not Specified]
Time Frame After operation on tha days 2, 7, 30, monthly
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 6 2 8
Measure Type: Number
Unit of Measure: patients with non-severe adverse events
3 2 7
3.Secondary Outcome
Title Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology
Hide Description [Not Specified]
Time Frame After operation or 1st day after operation, 7th day, 30th day, monthly
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 6 1 8
Overall Number of Units Analyzed
Type of Units Analyzed: Metastases
12 1 14
Measure Type: Number
Unit of Measure: complete response (CR)
10 1 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Group I Group II Group III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group I Group II Group III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   1/2 (50.00%)   3/8 (37.50%) 
Gastrointestinal disorders       
Small bowl obstruction  0/6 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Colon perforation  1/6 (16.67%)  0/2 (0.00%)  1/8 (12.50%) 
Abdominal abcess  0/6 (0.00%)  1/2 (50.00%)  1/8 (12.50%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group I Group II Group III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   2/2 (100.00%)   7/8 (87.50%) 
Cardiac disorders       
Atrial fibrilation  1/6 (16.67%)  0/2 (0.00%)  0/8 (0.00%) 
Supraventricular tachycardia  0/6 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders       
Ascites  0/6 (0.00%)  0/2 (0.00%)  2/8 (25.00%) 
Hepatobiliary disorders       
Transient liver failure  0/6 (0.00%)  1/2 (50.00%)  2/8 (25.00%) 
Cholestatic icterus  0/6 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Biliary fistula  0/6 (0.00%)  0/2 (0.00%)  2/8 (25.00%) 
Infections and infestations       
Infection NOS  3/6 (50.00%)  1/2 (50.00%)  6/8 (75.00%) 
Fever  2/6 (33.33%)  0/2 (0.00%)  0/8 (0.00%) 
Pneumonia  0/6 (0.00%)  1/2 (50.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  0/6 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders       
Wound infection  0/6 (0.00%)  1/2 (50.00%)  0/8 (0.00%) 
Vascular disorders       
Pulmonary hypertension  1/6 (16.67%)  0/2 (0.00%)  0/8 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gregor Sersa, PhD
Organization: Institute of Oncology Ljubljana
Phone: +386 1 5879 434
EMail: gsersa@onko-i.si
Layout table for additonal information
Responsible Party: Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier: NCT01264952     History of Changes
Other Study ID Numbers: 03-Z 16/KSOPKR-6
First Submitted: December 15, 2010
First Posted: December 22, 2010
Results First Submitted: December 19, 2014
Results First Posted: January 1, 2015
Last Update Posted: January 1, 2015