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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01264952 |
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Date of registration:
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15/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Liver Metastases With Electrochemotherapy
ECTJ |
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Scientific title:
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Treatment of Liver Metastases With Electrochemotherapy |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01264952 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Gregor Sersa, PhD (Biol.) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Oncology Ljubljana, Department of Experimental Oncology, Ljubljana, Slovenia |
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Name:
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Eldar Gadzijev, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Metastases
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Intervention(s)
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Procedure: Electrochemotherapy
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Primary Outcome(s)
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Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)
[Time Frame: After operation on day 7]
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Secondary Outcome(s)
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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]
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Number of Participants With Non-Serious Adverse Events
[Time Frame: After operation on tha days 2, 7, 30, monthly]
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Secondary ID(s)
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03-Z 16/KSOPKR-6
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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