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NCT00103155 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00103155
Other study ID # CDR0000410790
Secondary ID UCSF-H28355-2338
Status Active, not recruiting
Phase Phase 1
First received February 7, 2005
Last updated September 19, 2013
Start date September 2004

Study information
Verified date August 2005
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• conventional surgery

• radiofrequency ablation

Locations
Country Name City State
United States UCSF Comprehensive Cancer Center San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
University of California, San Francisco National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of radiofrequency ablation-associated complications at 2 weeks No
Secondary Amount of tumor destruction at 2 weeks No
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