Head and Neck CancerPhase 1NCT00103155
Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer
A Phase 1 study testing conventional surgery and radiofrequency ablation in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- conventional surgery and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-1674
About this study
Official title: Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- conventional surgery, radiofrequency ablation
- Keywords
- stage I papillary thyroid cancer
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
radiofrequency ablationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of radiofrequency ablation-associated complications at 2 weeks
Secondary outcomes (1)
Amount of tumor destruction at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Electron Kebebew, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103155
- Sponsor's protocol ID
- CDR0000410790
- Other IDs
- UCSF-H28355-23383-01, UCSF-03202
- Status last verified
- Aug 2005
- First submitted
- 7 Feb 2005
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT00103155
- Acronym / sponsor ID
- CDR0000410790
- Conditions
- Head and Neck Cancer
- Keywords
- stage I papillary thyroid cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- First posted
- 8 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgery | Procedure or surgery | – |
| radiofrequency ablation | Procedure or surgery | – |
Primary outcome
Frequency of radiofrequency ablation-associated complications at 2 weeks
1 secondary outcome
Amount of tumor destruction at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electron Kebebew, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing conventional surgery and radiofrequency ablation in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of radiofrequency ablation-associated complications at 2 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.