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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
radiofrequency ablation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage I papillary thyroid cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Frequency of radiofrequency ablation-associated complications at 2 weeks

Secondary Outcome Measures

Amount of tumor destruction at 2 weeks

Full Information

First Posted
February 7, 2005
Last Updated
September 19, 2013
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00103155
Brief Title
Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer
Official Title
Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage I papillary thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Primary Outcome Measure Information:
Title
Frequency of radiofrequency ablation-associated complications at 2 weeks
Secondary Outcome Measure Information:
Title
Amount of tumor destruction at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electron Kebebew, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-1674
Country
United States

12. IPD Sharing Statement

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

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