Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  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).

      Secondary

        -  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.
    

Intervention name(s): radiofrequency ablation; radiation therapy
Intervention type(s): Procedure; Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; large cell lung cancer; squamous cell lung cancer