Extrait

Background and study aims Basal cell carcinoma (BCC) is one of the most common types of skin cancer. It is usually caused by sun exposure and causes lumps, moles, lesions or patches of discoloured skin. It has a low risk of spreading, and when it is found early it can usually be treated through simple procedures, such as removal of the affected skin. As BCC is a slow-growing cancer it is important to consider that the cancer could return. During the last decade, electrochemotherapy (ECT) has become a well-established treatment for skin cancers. ECT is a way of getting chemotherapy (cancer medication) into the cancer cells by injecting chemotherapy into the blood and using an electrical pulse directly on the cancerous area (skin lesions). However, there is not a lot of evidence showing that it can help prevent BCC from returning. The aim of this study is to examine the feasibility, efficacy and toxicity of ECT in BCC to gain insights of long-term patient outcomes. Who can participate? Adults aged 18 and older with basal cell carcinoma. What does the study involve? Participants are enrolled in the study prior to their ECT treatment. After the treatment, participants are monitored for toxicity from the treatment until they are discharged from the hospital. They are then followed up at one week and one, two, six and 12 months after the treatment to assess the size of their skin lesions and toxicity of the treatment. In order to rule out long-term toxicity and tumour recurrence participants are then monitored every six to 12 months. What are the possible benefits and risks of participating? There are no notable benefits or risks with participating. Where is the study run from? Veneto Institute of Oncology IOV-IRCCS (Italy) When is the study starting and how long is it expected to run for? December 2005 to March 2013 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Luca Giovanni Campana

Critère d'inclusion

• Basal cell carcinoma (any type): local, locally-advanced, metastatic

Liens

• isrctn