Designed in collaboration with Kantonsspital Aarau, Paul Scherrer Institute, Uniklinik Balgrist, and University Hospital, 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 researchers announced the commencement of the study at the European Society for Hyperthermic Oncology (ESHO) Annual Conference.
During the conference researcher 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’.
Datta said: "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 tumor regression, higher tumor downstaging, superior resectability with organ and limb preservation and improved survival outcome without significant treatment related morbidity."
BSD Medical has developed the BSD-2000 system, which utilizes radiofrequency energy to deliver localized therapeutic heating. The central focusing of energy created by the system can be electronically focused to target the shape, size and location of the tumor, thus providing dynamic control of the heating delivered to the tumor region.
The US Food and Drug Administration has granted Humanitarian Device Exemption marketing approval for the BSD-2000 system for use in conjunction with radiation therapy to treat cervical cancer patients who are ineligible for chemotherapy.
The device obtained CE Mark approval for the commercial sale in Europe and in countries that recognizes the CE Mark.