A Pilot Study of Interventional Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size
- Patients with AJCC sixth edition Stage Ib or II non-small-cell lung cancer with
cytology or biopsy proven disease and a minimum tumor size of 3.5 cm are eligible.
- To be considered node negative for N2 disease, patients will have mediastinal lymph
nodes ≤ 1.5 cm and no clinically suspicious uptake on FDG PET in those areas.
- All patients are required to have been evaluated by a thoracic surgeon and have
either refused surgery or been deemed medically inoperable due to co-morbid
- The CT images of the chest must be reviewed by an experienced interventional
radiologist and the target lesion is determined to be in a location where RFA is
technically achievable based on the proximity of adjacent organs and structures.
- Age ≥ 18 years old
- Performance Status 0-2 (ECOG)
- 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 of <
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 entry
- Previous chest radiation to the region of interest.
- Pregnant or lactating women.
- A clinical diagnosis of bronchoalveolar carcinoma (BAC) will be made for patients in
whom tissue diagnosis is by cytology alone with adenocarcinoma shown and the
following radiographic criteria are met.