Overview

This trial is active, not recruiting.

Conditions cervical cancer, prostate cancer
Treatments hyperthermia, hdr brachytherapy
Sponsor University of California, San Francisco
Collaborator National Cancer Institute (NCI)
Start date April 2009
End date May 2015
Trial size 24 participants
Trial identifier NCT00911079, 08992, CDR0000643085, R01CA122276

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session
hyperthermia
Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)
hdr brachytherapy
Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants

Primary Outcomes

Measure
Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy
time frame: baseline to completion of study

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Principal investigator I-Chow J. Hsu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.