Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with stage I non-small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer|
- Overall survival at 2 years [ Designated as safety issue: No ]
- Overall time to local failure [ Designated as safety issue: No ]
- Overall time to recurrence [ Designated as safety issue: No ]
- Proportion of technical success [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||September 2006|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- Determine the overall 2-year survival rate after radiofrequency ablation (RFA) of lung nodules in high-risk patients with stage IA non-small cell lung cancer.
- Determine freedom from regional or distant recurrence in patients treated with this regimen.
- Determine freedom from local recurrence in the ablated lobe at 2 years in these patients.
- Determine the number of procedures deemed technical successes in patients treated with this regimen.
- Determine procedure-specific morbidity and mortality.
- Determine the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control in these patients.
- Determine the effect of RFA on short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function in these patients.
OUTLINE: This is a multicenter, pilot study.
A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60°C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature. Patients undergo fludeoxyglucose F18 positron emission tomography within 24-96 hours after the final treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 20 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109876
|United States, Alabama|
|UAB Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|United States, Michigan|
|William Beaumont Hospital - Royal Oak Campus|
|Royal Oak, Michigan, United States, 48073|
|United States, New York|
|Stony Brook University Cancer Center|
|Stony Brook, New York, United States, 11794-9446|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|United States, Ohio|
|Good Samaritan Hospital Cancer Treatment Center|
|Cincinnati, Ohio, United States, 45220|
|United States, Oregon|
|Providence Cancer Center at Providence Portland Medical Center|
|Portland, Oregon, United States, 97213-2967|
|United States, Rhode Island|
|Rhode Island Hospital Comprehensive Cancer Center|
|Providence, Rhode Island, United States, 02903|
|United States, Tennessee|
|H. Clay Evans Johnson Cancer Center at Memorial Hospital|
|Chattanooga, Tennessee, United States, 37404|
|United States, Texas|
|Medical City Dallas Hospital|
|Dallas, Texas, United States, 75230|
|United States, Utah|
|Huntsman Cancer Institute at University of Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Providence Cancer Center at Holy Family Hospital|
|Spokane, Washington, United States, 99207|
|Providence Cancer Center at Sacred Heart Medical Center|
|Spokane, Washington, United States, 99204|
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Damian E. Dupuy, MD||Rhode Island Hospital|
|Investigator:||Kamran Ahrar, MD||M.D. Anderson Cancer Center|
|Investigator:||Robert D. Suh, MD||Jonsson Comprehensive Cancer Center|