ACOSOG Z4099/ RTOG 1021: A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) versus Stereotactic Body Radiation Therapy in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC).

Summary:
The purpose of this study is to compare the results of sublobar resection (removal of a small portion of a lung) with or without brachytherapy (radioactive seeds placed in the body) to stereotactic body radiation therapy (SBRT), which is radiation given by a specialized x-ray machine that targets your lung cancer. The study will compare the effects these treatments have on you and your lung cancer to find out if SBRT is as effective as sublobar resection. This study is being done because SBRT may have fewer side effects than sublobar resection, but we do not know if SBRT is as effective at preventing your cancer from returning or at prolonging your life. SBRT is the current standard treatment for patients who are not candidates for surgery.

Eligibility and Treatment Plan:

• Male and female of at least 18 years old with biopsy-proven non-small cell lung cancer (NSCLC)
• Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection (surgical removal of a lobe of the lung)
• No evidence of distant metastases (spreading to the rest of the body)
• No previous chemotherapy or surgical resection for lung cancer

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