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Cervical Cancer | Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Cervical Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cervical Cancer

Prostate Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:HyperthermiaSingle course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)

Radiation:HDR brachytherapyCompletion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Hyperthermia with HDR brachytherapyHyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session

Study Status

Active, not recruiting

Start Date: April 2009

Completed Date: May 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy

Secondary Outcome: Evaluate the feasibility, defined as being able to administer hyperthermia at a specified temperature range and thermal dose.

Study sponsors, principal investigator, and references

Principal Investigator: I-Chow J. Hsu, MD

Lead Sponsor: University of California, San Francisco

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT00911079

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