An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System

The patient must be over the age of 18 years. Histologic confirmation of primary NSCLC of
the lung tumor must be complete prior to SBRT treatment.

The following stages of NSCLC patients would be eligible for the study:

Stage I:

T1 N0 M0 T2 N0 M0 (Size ≤ 5 cm)

Stage II:

T3 N0 M0 (Chest wall invasion only, Size ≤ 5 cm)

Staging Tumor size and characteristics: they will be determined by PET-CT scan

Nodal disease:

Patients with chest CT scan demonstrating hilar or mediastinal nodes <1cm and/or PET
negative would be considered N0 disease.

Patients who have hilar or mediastinal nodes > 1 cm and PET scan negative may be considered
N0 disease.

If PET scan demonstrates suspicious uptake or abnormal uptake, these patients would be
eligible, if a directed biopsy (by mediastinoscopy, Chamberlein procedure or other
modalities such as trans-bronchial biopsy, CT guided biopsy) is negative.

Metastases:

Evaluated by PET-CT scanning and biopsy as indicated

The patient must have an ECOG/Zubrod performance status of 0, 1, or 2. In order to be
considered medically-inoperable, the patient must meet at least one major criterion or meet
a minimum of 2 minor criteria as described below.

MAJOR CRITERIA:

FEV1 < 50% or predicted postoperative FEV1 < 40% DLCO < 50% or predicted postoperative DLCO
< 40% Exercise induced maximal exercise oxygen consumption (MVO2)<15 ml/kg/min Thoracic
surgery consultation should be obtained from a Board Certified Thoracic surgeon who in
collaboration with a radiation oncologist should determine if the patient is medically
operable This criterion would be mandatory

MINOR CRITERIA:

Age > 80 Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater
than 40mm Hg) Oxygen requirement (using the Medicare criteria for home oxygen requirements
[i.e., room air oxygen saturation of 88% or less]) Congestive heart failure (any three of
the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial
edema or cardiomegaly, rales, or congestion) Poor left ventricular function (defined as an
ejection fraction of 40% or less) Severe cerebral (with CVA or recent TIA) or severe
peripheral vascular disease Diabetes Mellitus with severe organ damage such as End-Stage
Renal Disease (ESRD), Blindness, Vascular disease.

CBC, Diff and platelets, Comprehensive metabolic panel within 28 days of registration
meeting the following criteria

leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL hemoglobin >9 g/dL (hemoglobin
may be supported by transfusion or erythropoietin or other approved hematopoietic growth
factors) platelets >100,000/mcL total bilirubin <1.5x institutional upper limit of normal
creatinine within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2
for patients with creatinine levels above institutional normal.

Females of child-bearing age must be using a reliable form of birth control. The patient
must provide a signed and dated written informed consent PRIOR to registration and prior to
undergoing any study-related procedures.

The patient must provide written authorization to allow for the use and disclosure of their
protected Health information.

Conditions for Patient Ineligibility The patient's weight exceeds the tolerances of the
institution's imaging and treatment platform/couch.

The patient has received thoracic radiation therapy in the same region as the current SBRT
planned treatment area. The patient has completed chemotherapy within 30 days of treatment.
T2: Tumor size > 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and ≤ 5cm), T4
tumors. Presence of N1, N2 or N3 disease per previously described criteria would also be
excluded.

Pancoast tumors would be excluded. Current distant metastatic disease (M1) (preferably
biopsy proven). The patient is a female with child-bearing potential who refuses to obtain
a serum pregnancy test prior to the initiation of treatment.

The patient is pregnant or a female who is nursing an infant. The patient is planning on
undergoing systemic therapy within 2 weeks after the last fraction of radiation The patient
has an active systemic or pulmonary infection.