Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer
Recruitment status was Active, not recruiting
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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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study |
- Frequency of radiofrequency ablation-associated complications at 2 weeks [ Designated as safety issue: No ]
- Amount of tumor destruction at 2 weeks [ Designated as safety issue: No ]
| Study Start Date: | September 2004 |
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 |
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| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94143-1674 | |
| Study Chair: | Electron Kebebew, MD | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00103155 History of Changes |
| Other Study ID Numbers: | CDR0000410790, UCSF-H28355-23383-01, UCSF-03202 |
| Study First Received: | February 7, 2005 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I papillary thyroid cancer |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Head and Neck Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Endocrine System Diseases Thyroid Diseases |
ClinicalTrials.gov processed this record on May 19, 2013