Site and disease selection for hyperthermia clinical trials.

Significant progress has been made in the past 20 years in understanding the biological basis of hyperthermia-induced cytotoxicity, thermoenhancement of radiation therapy and chemotherapy, and in the development of clinically applicable microwave, radiofrequency, ultrasound and thermometry equipment. Numerous uncontrolled trials have suggested strongly that hyperthermia in conjunction with radiation therapy or chemotherapy may contribute to improved local control rates for recurrent or metastatic cancer without excessive morbidity. Carefully designed and well-controlled site and disease-specific prospective randomized trials with standardized hyperthermia and radiation therapy techniques, adequate thermometry, precise end points for tumour control and normal tissue toxicity are now essential to establish the role of hyperthermia in cancer management. Criteria for tumour site selection will be explored for trials employing radiation therapy and local-regional hyperthermia. Examples of sites selected will be presented which represent areas that can, with current technology, usually be adequately heated, and in which significant patient benefit may result from improved local-regional control.