Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX)
have longer time to local recurrence as compared to the patients treated by SR (local
recurrence includes recurrence within the same lobe or hilum [N1 nodes], or progression at
the staple line after treatment effects such as scarring have subsided).

SECONDARY OBJECTIVES:

I. To compare procedure specific morbidity and mortality between study arms. II. To compare
overall survival and failure-free survival between study arms. III. To assess freedom from
regional or distant recurrence. IV. To assess the effect of histological or cytologic
positive resection margins on time to local recurrence.

V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the
effect of brachytherapy on pulmonary function.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge
resection or anatomical segmentectomy.

ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative
brachytherapy comprising iodine I 125 implant at the resection margin.

After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36
months and then yearly for 2 years.

Inclusion Criteria:

- PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)

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

- Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size
estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)

- Patient must have a CT scan of the chest with upper abdomen within 60 days prior to
date of pre-registration

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

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

- Major criteria

- Forced expiratory volume in 1 second (FEV1) =< 50% predicted

- Diffusing capacity of the lungs 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 partial pressure of oxygen (pO2) =< 55 mm Hg or
peripheral capillary oxygen saturation (SpO2) =< 88%

- Partial pressure of carbon dioxide (pCO2) > 45 mm Hg

- 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

- No prior invasive malignancy, unless disease-free for >= 5 years prior to
pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)

- PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)

- Patient must have biopsy-proven NSCLC

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