Randomized Phase II Trial of Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients With Early Stage Non-Small Lung Cancer (NSCLC)

The current standard of care for Stage I Non-Small Lung Cancer (NSCLC) is sublobar surgical resection. Recent trials have suggested that early stage NSCLC might be successfully treated with SBRT amongst those who are medically inoperable. SBRT is the precise delivery of a high dose of radiation to control tumors while limiting damage to surrounding normal tissues. Patients on the SBRT arm will receive 54 Grays (Gy) in 3 fractions. One gray is the absorption of one joule of energy, in the form of ionizing radiation, per kilogram of matter. Recent advances with three-dimensional conformal and Intensity Modulated Radiotherapy (IMRT) techniques can now compensate for lung motion and allow delivery of high-dose, single fractions to the primary lung tumor for patients with clinical state I NSCLC.

Local control and survival results appear promising. SBRT for early stage lung cancer may offer a potentially equivalent, non-invasive treatment alternative to surgical resection. Additionally, SBRT may be associated with fewer complications and better quality of life. SBRT may be an acceptable or even preferred treatment option in higher-risk patients not able to tolerate a surgical lobectomy. This clinical dilemma is increasingly faced in our lung cancer practice at Mayo Clinic, with no comparative effectiveness data to guide treatment decisions.

Patients will be evaluated by both Thoracic Surgery and Radiation Oncology. Randomization can occur through either group but a patient must see both in consultation prior to randomization. For patients meeting enrollment criteria but unwilling to participate in randomization, observational arms for each of SBRT and sublobar resection will enroll up to 24 patients as part of the 96 patient total.

The patients will receive the following tests as part of their clinical care:

• Computed Tomography (CT)-Positron Emission Tomography (PET) will be used for mediastinal imaging
• Endobronchial/endoscopic ultrasound (EBUS/EUS)-Fine Needle Aspiration (FNA) or mediastinoscopy will be used for pathologic assessment of level 2 lymph nodes (N2) greater than 1 cm in the short axis on CT scan and/or SUV greater than 1.5 fold background
• Follow-up CT scans at 6 months, 12 months, 18 months, and 24 months for the Surgery and SBRT groups.
• Follow-up Pulmonary Function Tests at 1 year