This study was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.
This study adopted a dose escalation protocol (an improved "two-stage two-dose group" design) to explore the safety and efficacy of visual proton surgery (single large fractionated doses of 34GyE and 39GyE) in the treatment of early peripheral NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Proton radiaotherapy (34GyE or 39GyE)
Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGThe incidence of grade ≥ 3 psAEs at 1 month
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 1 month after proton radiotherapy
The incidence of grade ≥ 3 psAEs at 1 year
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 1 year after proton radiotherapy
Primary tumor control at 1 year
Primary tumor control at 1 year
Time frame: 1 year after proton radiotherapy
Disease-free survival time
Disease-free survival time
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival time
Overall survival time
Time frame: From date of treatment until the date of death
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