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

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.

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.

Eligibility criteria:
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

Keywords: stage i non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer large cell lung cancer squamous cell lung cancer