This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC) non-small cell lung cancer (NSCLC).
This study aims to prospectively investigate the local regional control, overall survival, treatment related toxicities and quality of life (QOF) of elderly stage I NSCLC patients receiving stereotactic ablative radiotherapy (SABR) with a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy). Patients' general characteristics, treatment modality, dose-volume histogram (DVH) parameters, toxicity profiling, quality of life, pattern of failure as well as survival time will be prospective recorded for the analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy
Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGLocal regional progression free survival
Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.
Time frame: 2 year
Objective response rate
Tumor response to radiotherapy evaluated by RECIST 1.1
Time frame: 1 month after RT
Progression free survival
Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up.
Time frame: 2 year
Overall survival
Duration between radiotherapy commencement and any cause of death or last date of follow up.
Time frame: 2 year
Grade ≥ 2 radiation induced normal tissue toxicity
Incidence of radiation induced toxicities on lung, oesophagus, rib or chest wall pain assessed by CTCAE v 4.0
Time frame: 1 year
Questionnaire on quality of life
Physical and psychologic status assessed by specific questionnaire
Time frame: 2 year
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