Phase II Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Primary Objective: Evaluate local tumor control with individually optimized lung tumor SABR.
Tumor control will be assessed by CT, PET-CT, and if appropriate, biopsy. The trial will
focus on three cohorts: 1) patients with limited primary NSCLCs (T1aN0M0, T1bN0M0, T2aN0M0,
T2bN0M0, or T3N0M0) non-small cell lung cancer; 2) patients with a history of NSCLC who have
new limited primary NSCLC lesion(s); and 3) patients with more advanced lung cancer or lung
metastases from a variety of different cancers.

Secondary Objective:

- Evaluate the toxicity of individually optimized lung tumor SABR. Pulmonary, esophageal,
chest wall, skin, vascular, cardiac/pericardial, and neurologic (brachial
plexus/recurrent laryngeal/myelitis) toxicity will be scored by the CTCAE 4.0 criteria.

- Evaluate the feasibility of anatomically optimized audio-visual biofeedback
(AVB)-coached breath-hold technique assisted by fast delivery using gated RapidArc with
flattening free filter mode (FFF) in a subset of patients. Feasibility will be assessed
based on: i) The proportion of patients able to reproduce an anatomically-optimized
breath-hold with AVB-coaching during treatment. ii) The reduction in treatment delivery
time compared to gated free-breathing treatment.

- Determine progression free, metastasis free, and overall survival in patients treated
with individually optimized lung tumor SABR.

- Examine new biomarkers in lung tumor SABR patients.

Inclusion Criteria:

- Limited primary NSCLCs (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) or metastatic
lung tumors with no evidence of uncontrolled extrathoracic metastases.

- Up to 4 lesions may be included. For a single lesion the sum of three orthogonal
diameters can be no more than 20 cm. For multiple lesions, no lesion can have a sum of
orthogonal diameters greater than 15 cm.

- Both peripheral and central tumors are accepted for this trial.

- Age > = 18 years old

- Both men and women and members of all races and ethnic groups are eligible for this
trial.

- Note: Patients may be enrolled more than once (eg, for a new tumor)

- Both men and women and members of all races and ethnic groups are eligible for this
trial.

- Note: Patients may be enrolled more than once (e.g. for a new tumor)

Exclusion Criteria:

- Evidence of uncontrolled extrathoracic metastases

- Contraindication to receiving radiotherapy

- Age < 18 years old.

- Pregnant and breastfeeding women are excluded

- Prior radiation therapy is allowed but there should not be overlap with the prior high
dose regions unless approved by the protocol directors.