The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant Stereotactic Body Radiotherapy (SBRT) combined with immunochemotherapy versus neoadjuvant immunochemotherapy. The main questions it aims to answer are: Dose SBRT combined with immunochemotherapy improve event-free survival? Is SBRT combined with immunochemotherapy safe enough? Participants will: Receive neoadjuvant SBRT combined with immunochemotherapy or neoadjuvant immunochemotherapy. Tumor assessment will be performed prior to surgery. Surgery will be performed within 4 to 6 weeks (+ 7 days) after completion of the last cycle of immunochemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Radiation source: 6MV photon linear gas pedal is used. Position immobilization: supine position, hands up, vacuum bag or styrofoam immobilization. Radiotherapy plan design: 4DCT positioning, radiotherapy plan design at 20% respiratory time-phase CT, isocentric irradiation, IMRT or VMAT design. Definition of target area: Gross tumor volume (GTV) includes the primary tumor in the lung, excluding lymph nodes. Internal target volume (ITV); Internal target volume (ITV) is formed by the fusion of 10 respiratory phases of GTV; Planning target volume (PTV) is formed by expanding the ITV by 0.5 cm in all directions.
PD-L1 inhibitor
platinum-based double-agent chemotherapy
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGevent-free survival
include 2/3/5 event-free survival time
Time frame: 5 years
major pathologic response (MPR) rate
Time frame: 1-year
pathological complete response (PCR) rates
Time frame: 1-year
R0-resection rate
Time frame: 1-year
overall survival
2/3/5 years overall survival rate
Time frame: 5 years
safety
adverse events rate, postoperative complication rate, mortality rate.
Time frame: 1-year
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