Treatment of Liver Metastases With Electrochemotherapy (ECTJ)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Liver Metastases With Electrochemotherapy|
- Evaluation of toxicity related to electrochemotherapy (toxicity, symptoms) [ Time Frame: After operation on day 7 ] [ Designated as safety issue: Yes ]
- Clinical evaluation of the patient (pain scale, adverse events, concomitant treatment) [ Time Frame: After operation on tha days 2, 7, 30, monthly ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
- 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.
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.
|Contact: Gregor Sersa, PhD (Biol.)||+386 1 5879 firstname.lastname@example.org|
|Contact: Eldar Gadzijev, MD, PhDemail@example.com|
|Institute of Oncology Ljubljana||Recruiting|
|Ljubljana, Slovenia, 1000|
|Contact: Violeta Kaluza +386 1 5879 122 firstname.lastname@example.org|
|Sub-Investigator: Gregor Sersa, PhD (Biol.)|
|Principal Investigator: Eldar Gadzijev, MD, PhD|
|Sub-Investigator: Gorana Gasljevic, MD|
|Sub-Investigator: Erik Brecelj, MD, PhD|
|Sub-Investigator: Ibrahim Edhemovic, MD|
|Sub-Investigator: Damijan Miklavcic, PhD (Electrical Engineering)|
|Sub-Investigator: Tomaz Jarm, PhD (Electrical Engineering)|
|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|