Treatment of Liver Metastases With Electrochemotherapy
18 Years
N/A
Both
Liver Metastases
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of toxicity related to electrochemotherapy (toxicity, symptoms)
Outcome Time Frame:
After operation on day 7
Safety Issue:
Yes
Principal Investigator
Eldar Gadzijev, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institute of Oncology Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia
Authority:
Slovenia: Ethics Committee
Study ID:
03-Z 16/KSOPKR-6
NCT ID:
NCT01264952
Start Date:
November 2008
Completion Date:
November 2013
Related Keywords:
- Liver Metastases
- Liver metastases of colorectal cancer
- Bleomycin
- Electrochemotherapy
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
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