Pilot Study of a Catheter-based Ultrasound Hyperthermia System
OUTLINE: Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours
after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60
minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks.
Patients may then undergo 2 additional standard HDR brachytherapy sessions.
After completion of study therapy, patients are followed at 1 and 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all adverse events will be tabulated by type and presented separately for the first and second hyperthermia treatments. In addition, the safety data will be presented for the 2 subsets of patients corresponding to the plan for accrual for gynecological and prostate cancer subgroups: the first 3 patients in each subgroup, then the final 9 patients.
baseline to completion of study
I-Chow J. Hsu, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|