Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)

Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer

This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.

Inclusion Criteria:

• Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma diagnosed within 3 months prior to study enrollment.
• T1, N0, M0 or T2, N0, M0. (AJCC Lung 7th Edition)
• At least 18 years old at the time of consent.
• Adequate bone marrow function.
• Medically inoperable. Medically operable candidates are allowed if they refuse surgical resection.
• If the patient has a large pleural effusion, it must be biopsy negative.

Exclusion Criteria:

• Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3).
• Synchronous primary.
• T2 tumors > 5 cm; T3, T4 primary tumor.
• Previous radiotherapy for lung cancer.
• Concomitant local, regional, and/or systemic therapy during radiotherapy.
• Active systemic, pulmonary, and/or pericardial infection.