Guangzhou Concord Cancer Center
Guangzhou, Guangdong, China
Location status: Recruiting
NCT Number: NCT07412327
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
They were divided into peripheral type and central type according to the tumor location and received radical SBPT for Early-Stage Non-Small Cell Lung Cancer. . The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.
Other names: proton hypofractionated radiotherapy
Time frame: Up to 3 years
Progression Free Survival(PFS) is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method
Time frame: UP to 3 years
Overall Survival (OS) is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method.
Time frame: Up to 3 years
Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years.
Time frame: Up to 3 years
European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (EORTC QLQ-C30) (V3.0) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Time frame: Up to 3 years
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 29(EORTC QLQ-LC29) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Time frame: Up to 3 years
The proportion of subjects with toxic reactions of levels 3, 4 and 5 during the clinical trial period.The researchers record adverse events(AE) that appeared during the clinical trial cycle and grade it according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Contact information is provided by the study sponsor or research team.
Guangzhou Concord Cancer Center
Other
A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer
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