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
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Procedure: conventional surgery
Procedure: radiofrequency ablation
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency of radiofrequency ablation-associated complications at 2 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of tumor destruction at 2 weeks [ Designated as safety issue: No ]

Study Start Date: September 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103155

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-1674
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Electron Kebebew, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00103155     History of Changes
Other Study ID Numbers: CDR0000410790, UCSF-H28355-23383-01, UCSF-03202
Study First Received: February 7, 2005
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I papillary thyroid cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Head and Neck Neoplasms
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 28, 2014