Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy
About 5 % of all cancer patients experience cutaneous metastases. Ulcerating metastases can
be of great psychological distress for the patients and may also be painful. Radiation
therapy is standard treatment for ulcerating metastases, but there are no reports of
With this study we wish to compare electrochemotherapy with radiotherapy when treating
ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.
Patient recruitment: 98 patients are to be recruited, the patients will be randomized
between electrochemothreapy or radiotherapy. 49 patients will be treated in each arm.
Treatment: Patients will be treated in local or general anesthesia (inhaling max. 30 %
oxygen) Bleomycin will be given either intratumoral or intravenous. Electric pulses will be
administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate
electrodes are used in order to treat the affected area efficiently. Eight pulses at a
frequency of 5000 Hz or 1 Hz will be used for each application of the electrodes. In this
way, a large area can be treated within a short time. Post treatment, the area will be
covered by dry dressings, as are standardly used.
The patients will be seen at 8, 30, 60, 90 and 180 days post treatment. Chest X ray will be
taken before and after treatment for the patients receiving electrochemotherapy.
Evaluation: Evaluation is performed by measurement of lesion extension and digital
photography using the RECIST criteria. The first 10 patients in each treatment arm will also
be PET/CT-scanned before and one week after treatment.
Safety: Safety will be reported both in terms of evaluation of adverse events and in terms
of patient satisfaction determined by questionnaire, including the 'Derriford Appearance
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and response
Julie Gehl, Consultant
Copenhagen University Hospital at Herlev
Denmark: Ethics Committee and the Danish Medicines Agency