Status:
COMPLETED
Treatment of Liver Metastases With Electrochemotherapy
Lead Sponsor:
Institute of Oncology Ljubljana
Collaborating Sponsors:
University Medical Centre Ljubljana
Conditions:
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01264952
Start Date
November 1 2008
End Date
November 1 2013
Last Update
November 24 2020
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000