Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 1, 2015
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Institute of Oncology Ljubljana

Tracking Information
First Submitted Date  ICMJE December 15, 2010
First Posted Date  ICMJE December 22, 2010
Results First Submitted Date  ICMJE December 19, 2014
Results First Posted Date  ICMJE January 1, 2015
Last Update Posted Date January 1, 2015
Study Start Date  ICMJE November 2008
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2010)
Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms) [ Time Frame: After operation on day 7 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01264952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
  • Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment) [ Time Frame: After operation on tha days 2, 7, 30, monthly ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2010)
  • Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment) [ Time Frame: After operation on tha days 2, 7, 30, monthly ]
  • Treatment evaluation of tumor response - measurements of tumor lesions by US-Doppler, MRI, CT, histology [ Time Frame: After operation or 1st day after operation, 7th day, 30th day, monthly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Liver Metastases With Electrochemotherapy
Official Title  ICMJE Treatment of Liver Metastases With Electrochemotherapy
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Metastases
Intervention  ICMJE 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)
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2014)
16
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2010)
15
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01264952
Other Study ID Numbers  ICMJE 03-Z 16/KSOPKR-6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Oncology Ljubljana
Study Sponsor  ICMJE Institute of Oncology Ljubljana
Collaborators  ICMJE University Medical Centre Ljubljana
Investigators  ICMJE
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
PRS Account Institute of Oncology Ljubljana
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP