BSD Medical has initiated a Phase III clinical study using the BSD-2000 Hyperthermia System in combination with chemotherapy for the treatment of pancreatic cancer patients after R0/R1 surgical resection of their tumor.
The randomized, multicenter Phase III study has been initiated following completion of a Phase II study that utilised chemotherapy and hyperthermia to treat 21 inoperable pancreatic patients who were resistant to or had failed previous chemotherapy gemcitabine treatments, a patient population with a dire prognosis.
The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine) to chemotherapy (gemcitabine) alone.
The study had shown that there was one complete response (complete disappearance of the tumor), 3 partial responses (more than 50% tumor reduction), and 7 patients with stable disease (no tumor growth). The study results demonstrated a low toxicity rate and an overall survival of 16.9 months. By comparison, the median survival for inoperable pancreatic cancer patients after gemcitabine treatment was only 6 months.