Treatment of Liver Metastases With Electrochemotherapy
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of toxicity related to electrochemotherapy (toxicity, symptoms)
After operation on day 7
Eldar Gadzijev, MD, PhD
Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia
Slovenia: Ethics Committee