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Pilot Study of a Catheter-based Ultrasound Hyperthermia System


N/A
18 Years
N/A
Open (Enrolling)
Both
Cervical Cancer, Prostate Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy

Outcome Description:

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.

Outcome Time Frame:

baseline to completion of study

Safety Issue:

Yes

Principal Investigator

I-Chow J. Hsu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000643085

NCT ID:

NCT00911079

Start Date:

April 2009

Completion Date:

May 2018

Related Keywords:

  • Cervical Cancer
  • Prostate Cancer
  • Stage III, IV cervical cancer
  • Rising prostate specific antigen (PSA) after local therapy
  • Uterine Cervical Neoplasms
  • Fever
  • Prostatic Neoplasms

Name

Location
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115