Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue. In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.
Subjects will undergo an electronic navigational bronchoscopy (ENB) during which three markers will be placed around their tumor which will guide the delivery of proton beam radiation to their with more precision and accuracy. Subjects will receive a CT scan to obtain images to plan radiation treatment. Proton radiation will be delivered daily (4 or 5 consecutive days) on an outpatient basis at Massachusetts General Hospital. After the final dose of proton radiation subjects will be followed for 5 years. Subjects will be asked to return at 3 months, and then every 3 months until 2 years, and then every 6 months until 5 years. Subjects will receive a chest CT, tumor assessment by CT or PET, chest x-ray, pulmonary function tests and a physical exam.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of \> 3 cm)
Massachusetts General Hospital
Boston, Massachusetts, United States
Feasibility and safety
To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)
Time frame: 2 years
Safety and tolerability
Frequency of radiation pneumonitis in participants treated with proton radiation
Time frame: 2 years
Toxicity
Describe the acute and late toxicities of treatment using CTCAE v4.0
Time frame: 2 years
Efficacy
To describe radiological tumor responses
Time frame: 2 years
Disease Free survival
To calculate local, regional, and distant failure rates
Time frame: 2 years
Overall survival
To calculate the overall survival rate
Time frame: 2 years
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