Results of a phase I/II clinical trial of fractionated hyperthermia in combination with low dose ionizing radiation.

This paper addresses, in part, the current status of hyperthermia as a new clinical modality and reports the results of a large, prospective clinical trial employing microwave hyperthermia in combination with low doses of ionizing radiation. In the protocol employed, each treated area received 8 hyperthermia treatments of 1.5 hour combined with 1600 rad over a total period of 5 weeks. Patients were heated with microwaves of 915 or 300 MHz employing external applicators or internal intracavitary antennas. The results of this fractionation scheme are encouraging since in 121 fields that were treated completely according to protocol and were available for follow-up for at least 2 months, complete responses were observed in 65% of all cases, partial response in 30% and no response in only 5%. It is also important to note that toxicity was minimal throughout the study.