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Pilot Study of a Catheter-based Ultrasound Hyperthermia System

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ClinicalTrials.gov Identifier: NCT00911079
Recruitment Status : Terminated (Low Accrual)
First Posted : June 1, 2009
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
I-Chow Hsu, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE May 29, 2009
First Posted Date  ICMJE June 1, 2009
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE December 18, 2009
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • Frequency of treatment-related toxicities by treatment type [ Time Frame: Up to 3 months ]
    All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments.
  • Frequency of treatment-related toxicities by accrual plan [ Time Frame: Up to 3 months ]
    All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer
  • Proportion of patients treated according to the specified temperature and timing criteria. [ Time Frame: Up to 4 weeks ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
  • Frequency of treatment-related toxicities, including tissue burn or necrosis or pain ≥ grade 3
  • Proportion of patients treated according to the specified temperature and timing criteria
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • Average maximum prostate temperature (Tmax) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
  • Minimum temperature (Tmin) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
  • Median temperature (T50) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
  • Number of times temperature exceeded by 90% of the measured temperature points (T90) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
  • Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Official Title  ICMJE Pilot Study of a Catheter-based Ultrasound Hyperthermia System
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Cervical Cancer
  • Prostate Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Hyperthermia with HDR brachytherapy
Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session
Interventions:
  • Procedure: Hyperthermia
  • Radiation: HDR brachytherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 11, 2020)
13
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2009)
15
Actual Study Completion Date  ICMJE July 23, 2020
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00911079
Other Study ID Numbers  ICMJE CDR0000643085
08992 ( Other Identifier: University of California, San Francisco )
5R01CA122276 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party I-Chow Hsu, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: I-Chow J. Hsu, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP