Long-term goals are: 1) to develop advanced heating systems specifically designed for External Superficial Simultaneous thermoradiotherapy (ESST) to maximize thermal radiosensitization. The ESST development is currently funded by an R29 grant to Dr. E.G. Moros. 2) to perform clinical trials to determine safe ESST dose levels and to assess its benefits using current well-understood clinical hyperthermia systems, and eventually, with forthcoming systems. The proposed study builds on a previous intramural one that looked at the technical and clinical feasibility of ESST and which showed that ESST does not increase the complication rate over conventional sequential thermo-radiotherapy.
The specific aims are: 1) to conduct a prospective study to determine that increasing the number of ESST treatments increases the likelihood of achieving sessions in which each monitored location is heated to temperatures over 41 degrees C for at least 45 min., and 2) to demonstrate that this is tolerable.
These aims form the hypothesis to be tested. The methods for achieving the aims are: patients will receive radiotherapy, 400 cGy twice a week, to a total dose of 3200 cGy (total of 8 fractions). In addition, they will receive superficial hyperthermia. The hyperthermia will always be delivered simultaneously with some or all of the external beam radiotherapy fractions. The first 10 patients will receive a total of 4 ESST treatments and 4 radiation fractions over 4 weeks. The next 10 patients will receive a total of 6 ESST treatments (plus 2 radiation only fractions), and the last 10 patients will receive all 8 radiation fractions simultaneously with hyperthermia. This escalation scheme will ensure that any undue toxicity will be detected. Hyperthermia will be delivered with either microwave (915 MHz waveguide applicators) or ultrasound (multi-element applicators operating at 1 or 3.5 MHz). These are well-understood systems that may produce toxicity only to superficial tissues (depth < 6 cm). On the days the patients are to receive ESST, the hyperthermia will be initiated and delivered for approximately 30 minutes before the radiation fraction is administered (without cessation of the hyperthermia). The hyperthermia will then continue for approximately 30 more minutes. The potential benefit to patients is a greater likelihood of local control of the treated lesion. This benefit outweighs the potential risks from the therapy. Moreover, the knowledge and experience to be gained in this study may be of great benefit to patients who fail radiotherapy and/or chemotherapy.
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