Hyperthermia treatment is a radio sensitizer that increases the effect of radiation. During treatment the cancerous tumor is heated up to a temperature between 40 and 45 degrees Celsius (104 – 113 degrees Fahrenheit). Unlike healthy cells, cancer cells cannot tolerate these high temperatures. As a result, some cancer cells will be killed by the heat. Hyperthermia kills some cancer cells by raising the tumor temperature to a “high fever” range, making cancer cells more likely to be killed by the radiation therapy treatment, as well as making the tumor less able to recover from the effects of radiation treatment. The BSD-2000 will be used in conjunction with radiation therapy for the treatment of deep pelvic tumors. This population of patients would normally be treated with combination chemotherapy and radiation, but are ineligible for chemotherapy due to patient related factor(s). The BSD-2000 hyperthermia treatment will be conducted to provide additional evidence of the probable benefit and the safety of the use of hyperthermia delivered using the BSD-2000 Hyperthermia System in conjunction with radiation therapy in the treatment of deep pelvic tumors in patients. The BSD-2000 (HDE Study) will only be used clinically for its approved indication. The effectiveness of the BSD-2000 Hyperthermia System for treatment of advanced pelvic tumors has not been demonstrated. An HDE approval means that there are limited clinical data that suggest benefit and these data show that the probable benefit to health of the device outweighs the risk of injury or illness from its use. However, the data did not prove that there was any benefit from adding hyperthermia to radiation treatment. The BSD-2000 is not an alternative to chemotherapy treatment for advanced cervical cancer. Chemotherapy has been proven to be effective for improving survival, whereas hyperthermia has not.
The Treatment of Cervical Cancer Patients Who Will Receive Radiation Therapy in Conjunction with the BSD 2000 and Who Are Not Eligible for Chemotherapy
067-12Principal Investigator: Conducted at:
Long Beach MemorialCurrently enrolling additional patients: