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 is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer Read More

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