Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy

Inclusion Criteria:

1. Histological confirmation of non-small cell cancer will be required by either biopsyor cytology. The following primary cancer types are eligible: squamous cell carcinoma,adenocarcinoma with or without BAC features, large cell carcinoma with or withoutneuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma,or non-small cell carcinoma not otherwise specified.
2. Eligible patients must have appropriate staging studies identifying them as specificsubsets of the revised IASLC stage IA based on the following combination of TNMstaging: T1a,N0,M0 or T1b,N0,M0
3. A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with shortaxis diameter </= 1cm and no abnormal hilar or mediastinal uptake on PET will beconsidered N0. Patients with > 1 cm short axis diameter of hilar or mediastinal lymphnodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may stillbe eligible if directed tissue biopsy of all abnormally identified areas are negativefor cancer. Solitary pulmonary lesions </= 6mm will not be considered significant.
4. Patients must be considered a candidate for surgical resection of the primary tumor.Standard justification for deeming a patient medically operable based on pulmonaryfunction for surgical resection of NSCLC may include any of the following: BaselineFEV1 > 40% predicted, post-operative predicted FEV1 > 30% predicted, diffusioncapacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exerciseoxygen consumption > 50% predicted, absent severe pulmonary hypertension, absentsevere cerebral, cardiac, or peripheral vascular disease, and absent severe chronicheart disease.
5. Patients must be >/= 18 years of age.
6. The patient's Zubrod performance status must be Zubrod 0-2.
7. PET/CT scan to include both lungs, the mediastinum, and adrenal glands; Primary tumordimension will be measured on diagnostic CT and again on simulation CT. Must be donewithin 10 weeks prior to study entry.
8. Mediastinoscopy or endobronchial ultrasound (EBUS) guided biopsy of mediastinal lymphnodes is required for all patients. Must be done within 10 weeks of study entry.
9. MRI or CT scans of Brain if there are symptoms or signs suggesting brain metastases,must be done within 10 weeks prior to study entry.
10. Invasive Mediastinal Staging - All patients with CT and/or PET evidence of hilar (level 10) or mediastinal lymph nodes > 1.0 cm in the shortest diameter must be stagedby either cervical mediastinoscopy, esophageal endoscopic ultrasound guided biopsy, orendobronchial ultrasound guided biopsy.
11. Patients must sign a study-specific consent form.
12. Patients (men and women) of child bearing potential should use an effective (for them)method of birth control throughout their participation in this study.

Exclusion Criteria:

1. Patients with primary tumors > 3 cm.
2. Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor).
3. Direct evidence of regional or distant metastases after appropriate staging studies,or synchronous primary or prior malignancy in the past 3 years other thannonmelanomatous skin cancer or in situ cancer.
4. Previous lung or mediastinal radiotherapy.
5. Plans for the patient to receive other concomitant local therapy (including standardfractionated radiotherapy and surgery) while on this protocol except at diseaseprogression.
6. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryoor fetus.
7. Cannot achieve acceptable SABR planning to meet minimal requirement of target coverageand dose-volume constraints of critical structures (see RT techniques).