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


Phase 1
21 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Frequency of radiofrequency ablation-associated complications at 2 weeks

Safety Issue:

No

Principal Investigator

Electron Kebebew, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000410790

NCT ID:

NCT00103155

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage I papillary thyroid cancer
  • Thyroid Neoplasms
  • Head and Neck Neoplasms

Name

Location

UCSF Comprehensive Cancer CenterSan Francisco, California  94115