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	Treatment or Intervention	Phase
stage I papillary thyroid cancer	Procedure: conventional surgery  Procedure: hyperthermia  Procedure: radiofrequency ablation  Procedure: surgery	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

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

California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143-1674,  United States; Recruiting

Study chairs or principal investigators

Electron Kebebew, MD,  Study Chair,  University of California, San Francisco   

Study ID Numbers:  CDR0000410790; UCSF-H28355-23383-01; UCSF-03202; NCT00103155
Record last reviewed:  January 2005
Last Updated:  February 15, 2005
Record first received:  February 7, 2005
ClinicalTrials.gov Identifier:  NCT00103155
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08