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Liver MetastasesPhase 1/2ECTJNCT01264952

Treatment of Liver Metastases With Electrochemotherapy

A Phase 1/2 study testing Electrochemotherapy in people with Liver Metastases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Metastases
What is being tested?
Electrochemotherapy
How many people
16 participants
Where
1 siteSlovenia
Study dates
Nov 2008to Nov 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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.

Read more

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.

Read the 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.

Being tested
Electrochemotherapy
Keywords
Liver metastases of colorectal cancer, Bleomycin, Electrochemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElectrochemotherapyProcedure or surgery

    Also called Device: Cliniporator Vitae®, Drug: Bleomicin PHC 15 e. (United States Pharmacopeia - USP)

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)

    Measured: After operation on day 7

Secondary outcomes (2)

  1. Number of Participants With Non-Serious Adverse Events

    Measured: 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

    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

    Measured: After operation or 1st day after operation, 7th day, 30th day, monthly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2010 (estimated)
  2. Study startNov 2008
  3. Primary completionMar 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01264952
Sponsor's protocol ID
03-Z 16/KSOPKR-6
Acronym
ECTJ
Status last verified
Nov 2020
First submitted
15 Dec 2010
Last updated
24 Nov 2020
Data monitoring committee
Yes

Publications

  • Edhemovic I, Gadzijev EM, Brecelj E, Miklavcic D, Kos B, Zupanic A, Mali B, Jarm T, Pavliha D, Marcan M, Gasljevic G, Gorjup V, Music M, Vavpotic TP, Cemazar M, Snoj M, Sersa G. Electrochemotherapy: a new technological approach in treatment of metastases in the liver. Technol Cancer Res Treat. 2011 Oct;10(5):475-85. doi: 10.7785/tcrt.2012.500224.

    PubMed 21895032

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Electrochemotherapy in people with Liver Metastases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms) (time frame: After operation on day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01264952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.

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