Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00109876|
Recruitment Status : Completed
First Posted : May 4, 2005
Results First Posted : January 24, 2017
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation||Not Applicable|
I. To assess the overall 2-year survival rate after radiofrequency ablation (RFA).
I. To assess freedom from regional or distant recurrence. II. To assess freedom from local recurrence in the ablated lobe. III. To estimate the number of procedures deemed technical successes. IV. To evaluate procedure-specific morbidity and mortality. V. To explore the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control.
VI. To explore the effect of RFA on both short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function.
A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° Celsius (C). Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||February 2013|
Experimental: Treatment (RFA therapy)
A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo 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.
Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Other Name: CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation
- Overall Survival at 2 Years [ Time Frame: 2 years from registration ]Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.
- Overall Time to Local Failure [ Time Frame: Up to 2 years ]
The overall time to local failure was defined as the time from registration to documentation of
> local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.
- Overall Time to Recurrence [ Time Frame: Up to 2 years ]The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.
- Number of Procedures Deemed Technical Successes [ Time Frame: Up to 2 years ]The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.
- Incidence of Adverse Events [ Time Frame: Up to 2 years ]
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event.
> Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
- Change in Pulmonary Function From Baseline at Month 3 [ Time Frame: Baseline and Month 3 ]Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.
- Change in Pulmonary Function From Baseline at Month 24 [ Time Frame: Baseline and Month 24 ]Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Sacred Heart Medical Center|
|Spokane, Washington, United States, 99204|
|Providence Cancer Center at Holy Family Hospital|
|Spokane, Washington, United States, 99207|
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Damian E. Dupuy, MD||Rhode Island Hospital|