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

University of California San Francisco (UCSF)

Status and phase: Unknown; Phase 1

Conditions: Head and Neck Cancer

Treatments: Procedure: conventional surgery; Procedure: radiofrequency ablation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00103155

UCSF-03202

CDR0000410790

UCSF-H28355-23383-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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