Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To assess the overall 2-year survival rate after radiofrequency ablation (RFA).

SECONDARY OBJECTIVES:

I. To assess freedom from regional or distant recurrence. II. To assess freedom from local
recurrence in the ablated lobe. III. To estimate the number of procedures deemed technical
successes. IV. To evaluate procedure-specific morbidity and mortality. V. To explore the
utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in
predicting overall survival and local control.

VI. To explore the effect of RFA on both short-term (3 months post-RFA) and long-term (24
months post-RFA) pulmonary function.

OUTLINE:

A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo
RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60°
Celsius (C). Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the
target temperature.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 1 year.

Inclusion Criteria:

- PRE-REGISTRATION CRITERIA:

- Patients must have a lung nodule suspicious for clinical stage I non-small cell lung
cancer (NSCLC)

- Patient must have a mass =< 3 cm maximum diameter by CT size estimate: clinical stage
IA

- Patient must have been evaluated by a thoracic surgeon and been deemed at high risk
for a lung resection; NOTE: if the evaluating surgeon is not a member of American
College of Surgeons Oncology Group (ACOSOG), then an ACOSOG thoracic surgeon must
confirm with dated signature that the patient is high-risk and appropriate for RFA

- Patient must have fludeoxyglucose F 18 (FDG)-PET and a CT scan of the chest with
upper abdomen within 60 days prior to pre-registration; patient must have pulmonary
function tests (PFTs) within 120 days prior to registration

- Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance
status 0, 1, or 2

- Patient must meet at least one major criterion or meet a minimum of two minor
criteria as described below:

- Major criteria

- Forced expiratory volume in one second (FEV1) =< 50% predicted

- Diffusing capacity of the lung for carbon monoxide (DLCO) =< 50% predicted

- Minor Criteria

- Age >= 75

- FEV1 51-60% predicted

- DLCO 51-60% predicted

- Pulmonary hypertension (defined as a pulmonary artery systolic pressure
greater than 40 mmHg) as estimated by echocardiography or right heart
catheterization

- Poor left ventricular function (defined as an ejection fraction of 40% or
less)

- Resting or exercise arterial partial pressure of oxygen (pO2) =< 55 mmHg or
oxygen saturation (SpO2) =< 88%

- Partial pressure of carbon dioxide (pCO2) > 45 mmHg

- Modified Medical Research Council (MMRC) Dyspnea Scale >= 3

- Patient must not have had previous intra-thoracic radiation therapy

- Women of child-bearing potential must have negative serum or urine pregnancy test
within 2 weeks of registration

- REGISTRATION ACTIVATION CRITERIA:

- Patient must have histologically or cytologically proven NSCLC, 3 cm or smaller, as
determined by the largest dimension on CT lung windows

- Patient's tumor must be non-contiguous with vital structures: trachea, esophagus,
aorta, aortic arch branches and heart and lesions must be accessible via percutaneous
transthoracic route

- Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension
on CT scan or positive on PET scan) assessed by the following to confirm negative
involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound-guided needle
aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)