Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
This trial is active, not recruiting.
|Treatments||radiofrequency ablation, radiation therapy|
|Sponsor||Comprehensive Cancer Center of Wake Forest University|
|Collaborator||National Cancer Institute (NCI)|
|Start date||May 2007|
|End date||March 2010|
|Trial size||13 participants|
|Trial identifier||NCT00499447, CCCWFU 62306, CDR0000555009, IRB00001334|
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.
|Intervention model||single group assignment|
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
Two Year Progression Free Survival Rate
time frame: 2 years
Rate of Acute and Late Treatment-related Toxicity (Per CTCAE, v3.0) Related to Specific Symptoms
time frame: two years
Male or female participants from 18 years up to 120 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Cytology or biopsy-proven disease - Stage IA (T1N0M0) or select stage IB (T2N0M0 because of visceral pleural involvement or size ≥ 3.0 cm) - Tumor size ≤ 3.5 cm - No bronchioloalveolar carcinoma - Node-negative patients will have hilar or mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on fludeoxyglucose F 18 (FDG)-PET in those areas - Patients with > 1.5 cm lymph nodes and clinically suspicious FDG-PET uptake will still be eligible if directed tissue biopsy or needle aspiration of abnormally identified area are negative for cancer - Patients with > 1.5 cm and < 2.0 cm lymph nodes and no clinically suspicious FDG-PET uptake in those areas will still be eligible - All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to comorbid conditions - CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion must be determined to be in a location where radiofrequency ablation is technically achievable based on the proximity of adjacent organs and structures - Any patient with suspected M1 disease based on pre-treatment PET-CT imaging should have biopsy if possible - If the biopsy is positive, the patient should be treated as per the clinician's preference off of this protocol - If the biopsy is negative and representative of the lesion in question then the patient may be treated as per this protocol - If the biopsy is non-diagnostic, consideration should be given to repeat biopsy - If the repeat biopsy remains non-diagnostic or a biopsy is not feasible than the patient will not be eligible for this protocol and should be treated per the clinician's preference PATIENT CHARACTERISTICS: - Inclusion Criteria: - ECOG performance status 0-2 - Women of childbearing potential must have a negative pregnancy test - Fertile women must use effective contraception - Exclusion Criteria: - 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
|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|
|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.|
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