Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer

Inclusion Criteria:

- Histological confirmation of non-small cell cancer will not be required as primary
goal of this phase II trial is to look at toxicity. However, all primary non-small
cell lung cancers otherwise of following types are eligible: squamous cell carcinoma,
adenocarcinoma, large cell carcinoma, bronchioalveolar cell carcinoma, or non-small
cell carcinoma not otherwise specified.

- Eligible patients must have appropriate staging studies identifying them as specific
subsets of AJCC stage I or II based on only one of the following combinations of TNM
staging:

- T1, N0, M0

- T2 (≤ 5 cm), N0, M0

- Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or
mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or
mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic
uptake) may still be eligible if directed tissue biopsy of all abnormally identified
areas are negative for cancer. All patients with suspicious nodes will be evaluated
for mediastinal and hilar staging with bronchoscopy and (if amenable) bronchoscopic
biopsy (preferably navigational biopsy and/or endobronchial US guided biopsy).

- Zubrod performance status 0-2 within 4 weeks of study entry.

- Women of childbearing potential and male participants must use an effective
contraceptive method.

- Evaluations required at time of study entry:

- History & Physical by a radiation oncologist within 4 weeks of study entry;

- Vitals within 4 weeks of study entry;

- Evaluation by a thoracic surgeon (either via clinical examination and/or input at
multidisciplinary tumor board) prior to study entry;

- PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood gases
within 8 weeks prior to study entry;

- CT Chest within 6 weeks of study entry (preferably with intravenous contrast, unless
medically contraindicated) - to include the entirety of both lungs, the mediastinum,
liver, and adrenal glands; primary tumor dimension will be measured on this CT;

- Whole body positron emission tomography (PET) scan using FDG with adequate
visualization of the primary tumor and draining lymph node basins in the hilar and
mediastinal regions within 6 weeks prior to study entry.

- Informed consent signed by the subject and a member of the study team.

Exclusion Criteria:

- Patients with central tumors. Specifically; central location implies a tumor inside
the zone of the proximal bronchial tree defined as a volume 2 cm in all directions
around the proximal bronchial tree (carina, right and left main bronchi, right and
left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular
bronchus, right and left lower lobe bronchi

- Evidence of regional or distant metastases after appropriate staging studies.

- Synchronous primary NSCLC.

- Those with prior malignancy in the past 2 years other than non-melanomatous skin
cancer or in situ cancer or thyroid cancer.

- Previous lung or mediastinal radiotherapy.

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

- Patients with active systemic, pulmonary or pericardial infection.

- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
or fetus.