BSD Medical Corporation (NASDAQ:BSDM) reports initiation of a
randomized, multicenter 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 (complete removal or only microscopic tumor remaining). The
coordinating investigator is Rolf D. Issels, MD PhD, Department of
Medical Oncology, Klinikum Grosshadern, Munich University Medical
School, Munich, Germany. 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 Phase III study was initiated following completion of a Phase II
study that utilized 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. 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 is only 6 months. 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.
Pancreatic cancer is one of the deadliest and hardest to treat cancers
and is the fourth leading cause of cancer-related death. There were an
estimated 42,470 Americans and 60,000 Europeans diagnosed with
pancreatic cancer during 2009 and approximately 80% are inoperable. The
median survival period from the time of diagnosis until death is 3.5 to
6 months, depending on treatment, and less than 5 percent survive to
five years. Advanced pancreatic cancer patients currently have few
treatment options.
The study is scheduled to open for patient enrollment in March 2010. The
following clinical sites will participate in the clinical study:
Klinikum Grosshadern of Ludwigs-Maximilans-Universität München, HELIOS
Schlossbergklinik Oberstaufen, Rotkreuzkrankenhaus München,
Universitätsklinikum Düsseldorf, Klinikum Mannheim of Heidelberg
University Medical School, Universitätsklinikum Erlangen,
Universitätsklinikum Freiburg, Universitätsklinikum Tübingen, and
Charité University Medical School Berlin (all Germany); Kantonsspital
Aarau AG (Switzerland); and Ospedale Borgo Trento Verona (Italy).
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