Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
- Conditions
- Lung Cancer
- Interventions
- Procedure: radiofrequency ablationRadiation: radiation therapy
- Registration Number
- NCT00499447
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- ECOG performance status 0-2
- Women of childbearing potential must have a negative pregnancy test
- Fertile women must use effective contraception
- History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA level < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to study entry
- Pregnant or lactating women
PRIOR CONCURRENT THERAPY:
-
Exclusion Criteria:
-
Previous chest radiation to the lung or mediastinum
-
Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:
-
Radiotherapy
-
Radiofrequency ablation
-
Other antineoplastic interventional radiology techniques
-
Chemotherapy
-
Biological therapy
-
Vaccine therapy
-
Surgery
- Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial cell carcinoma allowed
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiofrequency Ablation with External Beam Radiation radiofrequency ablation Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy Radiofrequency Ablation with External Beam Radiation radiation therapy Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
- Primary Outcome Measures
Name Time Method Two Year Progression Free Survival Rate 2 years the number of patients surviving progression-free at two years.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States