Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments conventional surgery, radiofrequency ablation
Phase phase 1
Sponsor University of California, San Francisco
Collaborator National Cancer Institute (NCI)
Start date September 2004
Trial identifier NCT00103155, CDR0000410790, UCSF-03202, UCSF-H28355-23383-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Measure
Frequency of radiofrequency ablation-associated complications at 2 weeks
time frame:

Secondary Outcomes

Measure
Amount of tumor destruction at 2 weeks
time frame:

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).