Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00103155
First received: February 7, 2005
Last updated: September 19, 2013
Last verified: August 2005

February 7, 2005
September 19, 2013
September 2004
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Frequency of radiofrequency ablation-associated complications at 2 weeks [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00103155 on ClinicalTrials.gov Archive Site
Amount of tumor destruction at 2 weeks [ Designated as safety issue: No ]
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Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer
Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Ultrasound-guided radiofrequency ablation may be effective treatment for thyroid cancer.

PURPOSE: This phase I trial is studying the side effects of radiofrequency ablation in treating patients who are undergoing surgery for thyroid cancer.

OBJECTIVES:

  • Determine the frequency of complications associated with radiofrequency ablation (RFA) in patients with low-risk papillary thyroid cancer undergoing thyroidectomy.
  • Determine the utility of RFA as a treatment option for these patients.

OUTLINE: This is a pilot study.

An electrosurgical probe is placed by ultrasound guidance into the center of the thyroid tumor. Patients undergo radiofrequency ablation directly to the tumor until the target temperature is reached* for 5 minutes. Patients then undergo standard thyroidectomy.

NOTE: *Takes approximately 15-30 minutes to reach target temperature.

After completion of study treatment, patients are followed at day 1, between days 14-21, and then periodically as deemed necessary.

PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study.

Interventional
Phase 1
Primary Purpose: Treatment
Head and Neck Cancer
  • Procedure: conventional surgery
  • Procedure: radiofrequency ablation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • Cytologically confirmed papillary thyroid cancer by fine needle aspiration

    • Low-risk disease
    • No poorly differentiated cytology
  • Intrathyroidal tumor

    • Located within the anterior two-thirds of the thyroid lobe
    • Tumor not adjacent to the trachea by neck ultrasound
  • Tumor ≤ 1.5 cm by neck ultrasound
  • Requires thyroidectomy
  • No cervical lymphadenopathy
  • No multicentric tumors by neck ultrasound
  • No evidence of lymph node metastasis

PATIENT CHARACTERISTICS:

Age

  • Over 21

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103155
CDR0000410790, UCSF-H28355-23383-01, UCSF-03202
Not Provided
Not Provided
University of California, San Francisco
National Cancer Institute (NCI)
Study Chair: Electron Kebebew, MD University of California, San Francisco
National Cancer Institute (NCI)
August 2005

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