Ultrasound Hyperthermia Therapy After Implant Radiation Therapy in Treating Patients With Urinary Tract Cancer, Gynecologic Cancer, or Head and Neck Cancer

Ultrasound Hyperthermia Therapy After Implant Radiation Therapy in Treating Patients With Urinary Tract Cancer, Gynecologic Cancer, or Head and Neck Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on May 29, 2009.  
Last Updated on November 12, 2011  
History of Changes
Sponsor: University of California, San Francisco
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00911079
  Purpose

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 urinary tract cancer, gynecologic cancer, or head and neck cancer.

Condition Intervention
Cancer Procedure: ultrasound hyperthermia treatment
Radiation: brachytherapy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

  • Frequency of treatment-related toxicities, including tissue burn or necrosis or pain ≥ grade 3 [ Designated as safety issue: Yes ]
  • Proportion of patients treated according to the specified temperature and timing criteria [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: April 2009
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the feasibility of delivering catheter-based ultrasound hyperthermia therapy after brachytherapy, defined as the ability to administer hyperthermia at a specified temperature range and thermal dose within a defined duration of time, in patients with urologic, gynecologic, or head and neck cancer.
  • Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy in these patients.

Secondary

  • 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of solid tumor, including 1 of the following:

    • Gynecologic cancer
    • Urologic cancer
    • Head/neck cancer
  • Candidate for standard high-dose rate brachytherapy

PATIENT CHARACTERISTICS:

  • No condition that, as judged by the principal investigator, would compromise compliance with the study objectives and procedures

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911079

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94143-1708
Contact: I-Chow J. Hsu, MD     877-827-3222     hsu@radonc17.ucsf.edu    
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: I-Chow J. Hsu, MD University of California, San Francisco
  More Information

Additional Information:

No publications provided

Responsible Party: Chris J. Diederich, UCSF Helen Diller Family Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00911079    
History of Changes
Other Study ID Numbers: CDR0000643085, UCSF-08992, H10778-32056
Study First Received: May 29, 2009
Last Updated: November 12, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
stage I vaginal cancer
stage II vaginal cancer
stage III vaginal cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
stage I vulvar cancer
stage II vulvar cancer
stage III vulvar cancer
stage IV vulvar cancer
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
stage I renal cell cancer

Additional relevant MeSH terms:

Fever
Head and Neck Neoplasms
Urologic Neoplasms
Body Temperature Changes
Signs and Symptoms
Neoplasms by Site
Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on August 21, 2012

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