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

NCT ID: NCT00103155

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

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.

Conditions

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Head and Neck Cancer

Keywords

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stage I papillary thyroid cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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conventional surgery

Intervention Type PROCEDURE

radiofrequency ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Principal Investigators

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Electron Kebebew, MD

Role: STUDY_CHAIR

University of California, San Francisco

Locations

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UCSF Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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UCSF-H28355-23383-01

Identifier Type: -

Identifier Source: secondary_id

UCSF-03202

Identifier Type: -

Identifier Source: secondary_id

CDR0000410790

Identifier Type: -

Identifier Source: org_study_id