Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Two Year Progression Free Survival Rate [ Time Frame: 2 years ]the number of patients surviving progression-free at two years.
- Rate of Acute and Late Treatment-related Toxicity (Per CTCAE, v3.0) Related to Specific Symptoms [ Time Frame: two years ]
|Actual Study Start Date:||May 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|