Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Not Applicable

Terminated

• Conditions: Prostate Cancer; Cervical Cancer
• Interventions: Procedure: Hyperthermia; Radiation: HDR brachytherapy

• Registration Number: NCT00911079
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Study Start: 2009-12-18
• Primary Completion: 2020-07-23
• Study Completion: 2020-07-23
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients treated according to the specified temperature and timing criteria.	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
Frequency of treatment-related toxicities by accrual plan	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
Frequency of treatment-related toxicities by treatment type	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)	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)	Up to 4 weeks	Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Average maximum prostate temperature (Tmax)	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)	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)	Up to 4 weeks	Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States