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

• Histological confirmation of non-small cell cancer will be required by either biopsy or cytology. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without BAC features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.
• Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised IASLC stage IA based on the following combination of TNM staging: T1a,N0,M0 or T1b,N0,M0
• A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with short axis diameter 1 cm short axis diameter of 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. Solitary pulmonary lesions 40% predicted, post-operative predicted FEV1 > 30% predicted, diffusion capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease.
• Patients must be >/= 18 years of age.
• The patient's Zubrod performance status must be Zubrod 0-2.
• PET/CT scan to include both lungs, the mediastinum, and adrenal glands; Primary tumor dimension will be measured on diagnostic CT and again on simulation CT. Must be done within 10 weeks prior to study entry.
• Mediastinoscopy or endobronchial ultrasound (EBUS) guided biopsy of mediastinal lymph nodes is required for all patients. Must be done within 10 weeks of study entry.
• 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.
• 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 staged by either cervical mediastinoscopy, esophageal endoscopic ultrasound guided biopsy, or endobronchial ultrasound guided biopsy.
• Patients must sign a study-specific consent form.
• 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

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