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

Inclusion Criteria

• •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.