Pilot Study of a Catheter-based Ultrasound Hyperthermia System (08992)

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ClinicalTrials.gov Identifier: NCT00911079

Recruitment Status : Active, not recruiting

First Posted : June 1, 2009

Last Update Posted : January 24, 2019

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

I-Chow Hsu, University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer Prostate Cancer	Procedure: Hyperthermia Radiation: HDR brachytherapy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	24 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Actual Study Start Date :	April 2009
Estimated Primary Completion Date :	September 2020
Estimated Study Completion Date :	September 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Prostate cancer

MedlinePlus related topics: Fever Ultrasound

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hyperthermia with HDR brachytherapy Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session	Procedure: Hyperthermia 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

Outcome Measures

Primary Outcome Measures :

Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy [ Time Frame: baseline to completion of study ]
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.

Secondary Outcome Measures :

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 ]
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 ]
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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911079

Locations

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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143-1708

Sponsors and Collaborators

University of California, San Francisco

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	I-Chow J. Hsu, MD	University of California, San Francisco

More Information

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Responsible Party:	I-Chow Hsu, Professor, Radiation Oncology, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00911079 History of Changes
Other Study ID Numbers:	CDR0000643085 08992 ( Other Identifier: 10-03844 ) R01CA122276 ( U.S. NIH Grant/Contract )
First Posted:	June 1, 2009 Key Record Dates
Last Update Posted:	January 24, 2019
Last Verified:	January 2019

Keywords provided by I-Chow Hsu, University of California, San Francisco:


Stage III, IV cervical cancer Rising prostate specific antigen (PSA) after local therapy

Additional relevant MeSH terms:

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Fever Uterine Cervical Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Neoplasms	Genital Neoplasms, Female Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Body Temperature Changes Signs and Symptoms

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