Pilot Study of a Catheter-based Ultrasound Hyperthermia System (08992)
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.
Radiation: HDR brachytherapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of a Catheter-based Ultrasound Hyperthermia System|
- Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy [ Time Frame: baseline to completion of study ] [ Designated as safety issue: Yes ]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.
- Evaluate the feasibility, defined as being able to administer hyperthermia at a specified temperature range and thermal dose. [ Time Frame: baseline to completion of study ] [ Designated as safety issue: No ]The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions.
- Characterize the interstitial and endocavitary ultrasound heating technology by describing the thermal parameters including attainable temperature and thermal dose distribution and duration at the tumor treatment region. [ Time Frame: baseline to completion of study ] [ Designated as safety issue: No ]Parameters quantifying the therapeutic heat and thermal dose delivered to the tumor treatment regions encountered in the brachytherapy setting will be calculated. Thermal parameters as determined by thermometry measurements will be recorded at each of the two hyperthermia sessions (Tmax, Tmin, T50, T90, CEM (43)T(90). These values will be used to evaluate radial temperature and thermal dose profiles through the clinical target volume for each treatment. Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment and possibly by type of cancer (gynecologic or prostate).
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Hyperthermia with HDR brachytherapy
Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session
Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)Radiation: HDR brachytherapy
Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911079
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94143-1708|
|Principal Investigator:||I-Chow J. Hsu, MD||University of California, San Francisco|