August 18, 2014 — BSD Medical Corp. reported initiation of a Phase I/II study (HYPROSAR) using hyperthermia, delivered using either the BSD-2000 Hyperthermia System (BSD-2000) or the BSD-500 Hyperthermia System (BSD-500), combined with proton radiotherapy to treat patients with unresectable soft tissue sarcoma. The clinical study has been designed in joint cooperation with Kantonsspital Aarau, Paul Scherrer Institute, Villigen, Uniklinik Balgrist, Zurich, and University Hospital, Zurich. The Phase I/II study will include 28 adult patients with primary and unresectable soft tissue sarcomas of extremities and trunk (excluding abdominal tumors). The trial has been registered at ClinicalTrials.gov (NCT01904565) and is open for patient enrollment.

The researchers announced the study initiation at the European Society for Hyperthermic Oncology (ESHO) Annual Conference. Dr. N.R. Datta presented the basis for the study, "Thermoradiobiological basis of ''HYPROSAR'': A clinical trial with hyperthermia and proton radiotherapy in unresectable soft tissue sarcoma." During the presentation, Datta stated that studies have demonstrated that hyperthermia increases the efficacy of radiation with minimal morbidity, is especially cytotoxic for large bulky tumors, and prevents the repair of radiation induced DNA damage. He also reported that proton beam radiotherapy has superior physical dose distribution profiles, as compared to conventional radiotherapy. Datta concluded, "Consequently, for unresectable primary and recurrent soft tissue sarcomas, the thermoradiobiological and physical advantages of hyperthermia and proton beam radiotherapy could be expected to produce a greater tumour regression, higher tumour downstaging, superior resectability with organ and limb preservation and improved survival outcome without significant treatment related morbidity."

For more information: www.BSDMedical.com

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