A Phase 2 interventional study of Carbon ion beam radiotherapy in Non-small Cell Lung Cancer, sponsored by Shanghai Proton and Heavy Ion Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Shanghai Proton and Heavy Ion Center · Phase 2, Interventional, and Treatment
To investigate the efficacy of carbon ion therapy for stage Ia-IIa primary peripheral non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was local control rate, overall survival (OS) and toxicities.
Exclusion Criteria:
patients received carbon ion radiotherapy
Radiation: Carbon ion beam radiotherapy
Patients receive carbon ion radiotherapy of 12GyE per fraction, totally 4 fractions. Patients with tumors ≥4cm should receive at least 4 cycles of platinum-based doublet chemotherapy.
disease progression-free survival rate
disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.
Time frame: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
local control rate
local control rate was defined was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up
Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months
overall survival rate
overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up
Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months
Incidence of Treatment-induced Adverse Events [Safety and Tolerability]
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.
Time frame: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months
Plan to share: Undecided
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Shanghai Proton and Heavy Ion Center