Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study
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 6 weeks, 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and safety
To establish the feasibility and safety of fiducials placement by electromagnetic navigational brochoscopy (ENB)
Henning Willers, M.D.
Massachusetts General Hospital
United States: Institutional Review Board
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