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Treatment of Liver Metastases With Electrochemotherapy (ECTJ)

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: NCT01264952
Recruitment Status : Completed
First Posted : December 22, 2010
Results First Posted : January 1, 2015
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Institute of Oncology Ljubljana

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Liver Metastases Procedure: Electrochemotherapy Phase 1 Phase 2

Detailed Description:

The study will be conducted on patients with colorectal cancer with synchronous or metachronous liver metastases. Included will be 10-15 patients.

Predominantly, patients with synchronous metastases will be included into the study. These patients present liver metastases at the time of primary tumor resection. Electrochemotherapy will be performed on one metastasis not more than 3 cm in largest diameter at the time of the primary tumor operation, but patients have to have at least 2 to 8 metastases. These metastases will be aimed to be resected in the following operation. It is a standard procedure that liver metastases are resected 2-3 months after the primary tumor resection, in the meantime they are on standard chemotherapeutic protocol (FOLFOX, FOLFIRI, Capecitabine). Only in the case of solitary metastasis smaller than 3 cm in diameter, it is resected during the resection of the primary tumor. In the study additional antitumor effectiveness of electrochemotherapy to other treatment (chemotherapy) will be evaluated, compared to non-electrochemotherapy treated metastases. Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and ultrasonography (US), in a monthly interval. Two to three month after the first operation the treated and untreated metastases will be resected and thorough histological analysis performed.

The second group of patients will be with metachronous liver metastases not larger than 3 cm in diameter, that location is in the vicinity of hollow liver structures and would not be possible to resect them without extensive and potentially jeopardizing liver resection. One of them will be treated by electrochemotherapy. In a month interval treatment effectiveness will be evaluated by MRI. In the case that metastases will decrease in size and to the situation that metastases are resectable, second operation will be performed, metastases resected and thorough histopathological evaluation performed. Otherwise standard treatment procedure will be performed (chemotherapy).

All patients will be treated after the procedure is thoroughly described to them, and have signed informed consent.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Liver Metastases With Electrochemotherapy
Study Start Date : November 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : November 2013
Arms and Interventions
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Intervention Details:
  • 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.

    Other Names:
    • Device: Cliniporator Vitae®
    • Drug: Bleomicin PHC 15 e. (United States Pharmacopeia - USP)

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

Secondary Outcome Measures :
  1. Number of Participants With Non-Serious Adverse Events [ Time Frame: After operation on tha days 2, 7, 30, monthly ]
  2. 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 ]

    Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:

    Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR



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

Inclusion Criteria:

  • Patients with measurable liver metastases, presented simultaneously with primary tumor, aimed at primary tumor resection and in a 2-3 month interval resection of liver metastases. One metastasis will be treated by electrochemotherapy, not larger than 3 cm in diameter.
  • Metastasis has to be accessible for application of electrochemotherapy during the operation, without major liver manipulation or mobilization in order not to create situation that would hamper feasibility of the second operation; resection of metastases.
  • Patients with metachronous liver metastases, that are positioned in unresectable liver area, near blood vessels, but inoperable patients.
  • Recurrent liver metastases, not more than 3, that are not larger than 3 cm in diameter.
  • Histologically and cytologically confirmed cancer, any histological differentiation.
  • Life expectancy more than 3 month.
  • Performance status Karnofsky ≥ 70 or (World Health Organization) WHO ≥ 2.
  • Age more than 18.
  • The patient must be offered standard treatment.
  • Electrochemotherapy is offered to the patients in the case of the disease progression during the standard treatment, in the case or metastases recurrence, or when they refuse standard treatment.
  • Treatment 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.

Exclusion Criteria:

  • Metastases more than 3 cm in diameter.
  • Synchronous unresectable metastases.
  • Metachronous unresectable metastases or bigger than 3 cm in diameter.
  • Visceral, bone or diffuse metastases.
  • Coagulation disturbances.
  • Allergic reaction to bleomycin, or cumulative dose of 250 mg/m2 bleomycin received.
  • Impaired kidney function (creatinin > 150 µmol/l).
  • Patients with hearth failure or pace maker.
  • Patients with epilepsy.
  • Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma.
  • Pregnancy.
Contacts and Locations
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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): NCT01264952


Locations
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Slovenia
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institute of Oncology Ljubljana
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Eldar Gadzijev, MD, PhD Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia
Study Director: Gregor Sersa, PhD (Biol.) Institute of Oncology Ljubljana, Department of Experimental Oncology, Ljubljana, Slovenia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier: NCT01264952    
Other Study ID Numbers: 03-Z 16/KSOPKR-6
First Posted: December 22, 2010    Key Record Dates
Results First Posted: January 1, 2015
Last Update Posted: November 24, 2020
Last Verified: November 2020
Keywords provided by Institute of Oncology Ljubljana:
Liver metastases of colorectal cancer
Bleomycin
Electrochemotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
 Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases