Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00499447|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : March 1, 2013
Last Update Posted : January 18, 2018
RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiofrequency ablation together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together with external-beam radiation therapy works in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: radiofrequency ablation Radiation: radiation therapy||Not Applicable|
- To determine progession free survivial rates in patients with inoperable stage IA and select stage IB non-small cell lung cancer treated with external-beam radiation therapy and radiofrequency ablation (RFA).
- To determine the acute and late toxicity of combining RFA with external-beam radiation therapy.
- To determine the patterns of failure at time of first relapse.
- To determine the rate of overall survival at 1 and 2 years after treatment.
- To evaluate the ability of peak standard uptake value (SUV) and max SUV obtained prior to RFA to predict local control and time to progression.
- To measure post RFA/simulation (treatment planning) PET max and peak SUV's and correlate this data with local control at 1 and 2 years.
- To evaluate the ability of peak and max SUV's for fludeoxyglucose F 18 obtained shortly after radiotherapy (post-treatment) to predict local control and time to progression.
- To evaluate PET-CT data and its utility in guiding radiation therapy treatment planning.
- To explore the use of dual time point imaging PET data obtained to predict local control and also to differentiate between recurrence versus inflammation when applicable.
- To assess physical function as a prognostic measure, and to determine the impact of treatment on physical function.
- To evaluate the impact of treatment on generic and disease-specific quality of life.
OUTLINE: Patients undergo fludeoxyglucose F18 positron emission tomography (FDG-PET) and CT scan at baseline. Patients then undergo radiofrequency ablation (RFA). Beginning within 5 weeks after completion of RFA, patients undergo external-beam radiation therapy once daily, 5 days a week, for 5-6 weeks. FDG-PET/CT scan is repeated 3-4 weeks after RFA and 12-16 weeks after completion of external-beam radiation therapy.
Quality of life is assessed at baseline, during treatment, and at 16 weeks and at 1 year after completion of treatment.
After completion of study treatment, patients are followed periodically for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography|
|Actual Study Start Date :||May 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Radiofrequency Ablation with External Beam Radiation
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
|Procedure: radiofrequency ablation Radiation: radiation therapy|
- Two Year Progression Free Survival Rate [ Time Frame: 2 years ]the number of patients surviving progression-free at two years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499447
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||William Blackstock, MD||Wake Forest University Health Sciences|