The objective of this trial is to determine if reducing the chemotherapy dose in electrochemotherapy is equally effective as using the standard dose for treating various types of skin tumors.
Electrochemotherapy involves administrating chemotherapy intravenously, followed shortly by a brief electrical pulse to the tumor. This pulses temporarily increases the tumor cells permeability, allowing the chemotherapy to enter more effectively.
Participants will undergo a single session of electrochemotherapy with either half the standard chemotherapy dose or the full standard dose. The size of the cutaneous tumors will be measured before treatment and again three months after the treatment to compare their response in both groups. To monitor the tumors, as well as assess the adverse events and quality of life, participants must attend follow-up visits at two weeks, three months and twelve months. Additional visits may be scheduled at one, two, four and six months, if necessary, as determined by the clinician or the patient. Concentration of chemotherapy will be measured in blood samples and in samples from the treated tumor and normal skin.
Trial subject > 18 years.
Trial subject must be able to understand the participant information.
Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
Life expectancy > 3 months.
Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment.
Allergy or hypersensitivity to bleomycin.
Acute lung infection.
Severely impaired lung function or any lung condition the investigator deems severe.
Julie Gehl
Lead sponsor
Zealand University Hospital
Sponsor institution
Roskilde University
Collaborator
Herlev Hospital
Collaborator