Randomized Trial Comparing Standard and Reduced Dose Bleomycin in Electrochemotherapy for Cutaneous Malignancies

What this Trial Is About

Researchers are evaluating whether using half the usual dose of bleomycin in electrochemotherapy is as effective as the standard full dose for treating various types of skin tumors. Electrochemotherapy combines chemotherapy with brief electrical pulses that increase tumor cell permeability, allowing the drug to enter more effectively. This trial focuses on patients with cutaneous malignancies, including primary skin cancers and cutaneous metastases, to assess if reducing the chemotherapy dose can maintain treatment effectiveness while potentially lowering side effects. Participants will receive a single session of electrochemotherapy with either the standard bleomycin dose (15,000 IU/m2) or a 50% reduced dose (7,500 IU/m2), administered intravenously. Eight minutes after the infusion, electric pulses are applied to the tumor using a specialized device to ensure full coverage including a margin of surrounding tissue. The trial is randomized, double-blinded, and stratified by tumor size. Biological samples including blood and tumor biopsies will be collected at multiple time points on treatment day to measure bleomycin concentration and study drug distribution. Participants will be followed for tumor response and safety with mandatory visits at 2 weeks, 3 months, and 12 months after treatment, with optional visits as needed. Tumor size will be measured and photographed at all visits. Pain, wound healing, scar formation, adverse events, and quality of life will be assessed using questionnaires and clinical evaluations. The main outcome is the tumor response rate three months after treatment. The trial expects to enroll 55 patients and last about three years, concluding after all participants complete the 12-month follow-up.

The Effect of Reduced Bleomycin in Electrochemotherapy Treatment