The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.
The objectives of this clinical evaluation are to assess the outcomes of patients who undergo stereotactic radiosurgery (SRS) to treat primary early stage non-small cell lung cancer (NSCLC) in patients (comprising of two cohorts, peripheral and central) who are not candidates for surgical resection because of high operative risks. In particular, the effect of CyberKnife SRS on clinical response rate, local control, progression-free survival, overall survival, dyspnea and QOL (for U.S. sites), and radiological findings over two years after treatment will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Central tumors defined as \< 2 cm from carina and \< 2 cm from right and left mainstem bronchus and/or \< 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy) Peripheral tumors are defined as being \> 2 cms from the carina and \> 2 cms from the right and left mainstem bronchus and/or \> 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)
St Joseph's Hospital/Barrow Neurological Institute
Phoenix, Arizona, United States
Local progression-free survival, local disease progression, clinical response rate, regional recurrence-free survival, distant recurrence-free survival.
Time frame: 5 years
To characterize and compare quality of life before and after stereotactic radiosurgery treatment. To assess procedure-related outcomes after stereotactic radiosurgery of lung tumors.
Time frame: 5 years
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Community Regional Medical Center
Fresno, California, United States
Stanford University
Palo Alto, California, United States
Penrose Cancer Center
Colorado Springs, Colorado, United States
Denver CyberKnife
Lone Tree, Colorado, United States
North Florida Radiation Oncology
Gainesville, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Advocate Christ Med Center
Oak Lawn, Illinois, United States
Parkview Cancer Center
Fort Wayne, Indiana, United States
...and 13 more locations