US-based BSD Medical has initiated a Phase I/II trial (Hyprosar) using hyperthermia, delivered using either the BSD-2000 Hyperthermia System or the BSD-500 Hyperthermia System, combined with proton radiotherapy to treat patients with unresectable soft tissue sarcoma.
Twenty eight adult patients with primary and unresectable soft tissue sarcomas of extremities and trunk (excluding abdominal tumours) will be included in the trial, which has been designed in joint cooperation with Kantonsspital Aarau, Paul Scherrer Institute, Uniklinik Balgrist, and University Hospital, Zurich.
Basis for the trial was presented by Dr N R Datta at the European Society for Hyperthermic Oncology (ESHO) Annual Conference.
"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 tumour regression, higher tumour downstaging, superior resectability with organ and limb preservation and improved survival outcome without significant treatment related morbidity."
The trials have also showed that hyperthermia increases the efficacy of radiation with minimal morbidity, is especially cytotoxic for large bulky tumours, and prevents the repair of radiation induced DNA damage.
Developed and patented exclusively by BSD, the BSD-2000 system uses radiofrequency (RF) energy to deliver localised therapeutic heating.
The central focusing of energy created by the system can be electronically focused to target the shape, size and location of the tumour, providing dynamic control of heating delivered to the tumour region.
The US Food and Drug Administration (FDA) has granted humanitarian device exemption marketing approval for the BSD-2000 system, to be used in conjunction with radiation therapy to treat cervical cancer patients who are ineligible for chemotherapy.
It has also secured CE Mark approval for the commercial sale in Europe, as well as in many countries outside of the European Union (EU).