Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of combining single fraction stereotactic body
radiation therapy (SBRT) followed by surgery, in thoracic malignancies.

SECONDARY OBJECTIVES:

I. To estimate overall survival (OS) and progression-free survival (PFS) after single
fraction SBRT followed by surgery, in thoracic malignancies.

II. To define any differences in quality of life/toxicity following SBRT based on tumor
location/stage/tumor type.

TERTIARY OBJECTIVES:

I. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies.

OUTLINE: Patients are assigned to 1 of 3 studies.

STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral
lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then
undergo thoracic surgery on day 28.

STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT
over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or
higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic
surgery on day 28.

After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6
months for 2 years, and then annually for 2 years.

Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I,
II, or IIIa)

- Participant is able to undergo surgery (planned lobectomy or wedge resection)

- Specifically, the participant has been or will have been cleared for surgery at
the time of enrollment; the surgeon can accept the baseline tests done within 45
days prior to SBRT to clear the patient for surgery

- Participants of child-bearing potential must agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence) during
treatment

- Participant or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Contraindication to SBRT (this includes the inability to cooperate with any aspect of
SBRT: such as the inability to lie still and breathe reproducibly)

- Previous radiotherapy to the lung or mediastinum

- Previous chemotherapy for this lung or mediastinum tumor; chemotherapy for another
invasive malignancy is permitted if it has been treated definitively and the patient
has remained disease free for > 3 years

- Previous surgery for this lung or mediastinum tumor

- Plans for the patient to receive other concomitant antineoplastic therapy (including
standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy,
and surgery) while on this protocol except at disease progression

- Patients with active systemic, pulmonary, or pericardial infection

- Pregnant or nursing female participants

- Unwilling or unable to follow protocol requirements

- Any condition which in the investigator?s opinion deems the participant ineligible

- Received an investigational agent within 30 days prior to enrollment

- Stage IIIb