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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: conventional surgery
* Procedure: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|nan|
|Procedure: radiofrequency ablation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of radiofrequency ablation-associated complications at 2 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of tumor destruction at 2 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I papillary thyroid cancer