Clinical trial NCT00911079: Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Official title: Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Prostate Cancer
Keywords: Stage III, IV cervical cancer
Rising prostate specific antigen (PSA) after local therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-06-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:

  * Cervical cancer Stage III or IV OR
  * Prostate cancer (with rising prostate specific antigen after prior local therapy)
* Age \>=18 years
* Eligible for brachytherapy as determined per clinical standard of care.
* Ability to give written informed consent and willingness to comply with the requirements of the protocol

Exclusion Criteria:

* Patients who are not candidates for HDR brachytherapy
* Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator

Primary outcomes:
measure: Frequency of treatment-related toxicities by treatment type
timeFrame: Up to 3 months
measure: Frequency of treatment-related toxicities by accrual plan
timeFrame: Up to 3 months
measure: Proportion of patients treated according to the specified temperature and timing criteria.
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Average maximum prostate temperature (Tmax)
timeFrame: Up to 4 weeks
measure: Minimum temperature (Tmin)
timeFrame: Up to 4 weeks
measure: Median temperature (T50)
timeFrame: Up to 4 weeks
measure: Number of times temperature exceeded by 90% of the measured temperature points (T90)
timeFrame: Up to 4 weeks
measure: Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: I-Chow J. Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: