Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer - Full Text View

Purpose

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	Intervention	Phase
Head and Neck Cancer	Procedure: conventional surgery Procedure: radiofrequency ablation	Phase I

MedlinePlus related topics:

Cancer Head and Neck Cancer Thyroid Cancer

ChemIDplus related topics:

Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Frequency of radiofrequency ablation-associated complications at 2 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Amount of tumor destruction at 2 weeks [ Designated as safety issue: No ]

Study Start Date:

September 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103155

Locations


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

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	Electron Kebebew, MD	UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000410790, UCSF-H28355-23383-01, UCSF-03202
First Received:	February 7, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00103155
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I papillary thyroid cancer

Study placed in the following topic categories:

Thyroid Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Endocrinopathy

Thyroid Diseases

Thyroid cancer, papillary

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00103155