Table 3.
Inclusion criteria | Exclusion criteria |
---|---|
Histologically basal cell carcinoma or cytologically located confirmed, in the head previously and neck untreated region cutaneous | Other malignancy at the time of inclusion |
Solitary tumors, with largest diameter up to 3 cm, in the region where curative (R0) surgery is feasible | Lesions not suitable for treatment with GET (invasion into the bone, infiltration of large vessels) |
Age 18-years or older | A life-threatening infection and/or severe heart failure and/or liver failure and/or other life-threatening systemic diseases |
Life expectancy > 3 months | Significantly reduced lung function, which requires the determination of DLCO. Patients should not be treated if DLCO is abnormal |
Physical performance in accordance with the Karnofsky scale ≥ 70 or < 2 in accordance with World Health Organization (WHO) scale | Treatment with immunosuppressive drugs, steroids and other drugs that would affect poor wound healing |
The patient must be capable of understanding the treatment procedure and possible adverse events, which may arise during treatment | Age under 18-years |
The patient must be capable of signing the informed consent to participate in the clinical study (voluntary and conscientious consent after education) | Major disruptions in the coagulation system (who does not respond to the standard therapy – replacement of vitamin K or freshly frozen plasma) |
Prior multidisciplinary to inclusion in advisory the trial, team the patient meeting must be presented at a | A chronic decline in the kidney function (creatinine > 150 μmol/L) |
Epilepsy | |
Pregnancy and breast-feeding | |
The patient’s incapability of comprehending the purpose or course of the trial, or not agreeing to be included in the trial | |
Patients unwilling or unable to comply with the protocol requirements and scheduled visits |
DLCO = Diffusing Capacity of the Lungs for carbon monoxide; GET = gene electrotransfer