The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. The main question it aims to answer is: \- Can the combination of SFRT and standard systemic therapy improve progression-free survival (PFS) compared to standard systemic therapy alone? Participants will: * Undergo SFRT treatment for oligoprogressive lesions, with specific dose fractionation determined by the radiation oncologist based on clinical parameters. * Continue their standard systemic therapy, which may include chemotherapy, targeted therapy, or immunotherapy, as adjusted by their treating physician. * Have regular follow-up assessments, including imaging studies to evaluate treatment response and monitor for disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The intervention includes SFRT for larger oligoprogressive lesions (≥4.5 cm in diameter), utilizing image-guided CT, including 4D-CT, with Lattice technique planning. The dose fractionation will be determined by the radiation oncologist based on clinical parameters, with peak doses ranging from 6-15 Gy/Fx and valley doses from 1.8-4 Gy/Fx, typically in 1-5 fractions. For smaller oligoprogressive lesions, stereotactic body radiotherapy (SBRT) or intensity-modulated radiotherapy (IMRT) will be selected based on clinical parameters.
Continuation or switch of prior standard regimen (chemotherapy, targeted TKI, or PD-1/PD-L1 inhibitor) at investigator discretion until further progression or intolerable toxicity.
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGProgression-Free Survival (PFS)
PFS will be determined based on radiological assessments using CT or MRI scans, according to the RECIST v1.1 criteria. Disease progression will be defined as an increase of at least 20% in the size of target lesions or the appearance of new lesions.
Time frame: From date of first study treatment to documented progression or death, assessed at 6 weeks, 12 weeks, 24 weeks, 48 weeks, and 72 weeks.
Objective Response Rate (ORR) of Irradiated Lesions
ORR will be assessed using RECIST v1.1 criteria. ORR includes complete response (CR) and partial response (PR). Tumor response will be evaluated through radiological imaging (CT or MRI) of the irradiated lesions
Time frame: 1 month after the completion of SFRT treatment and then every 3 months thereafter
Treatment-Related Adverse Events (TRAEs)
TRAEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence and severity of adverse events will be recorded at each follow-up visit, with a focus on grade 3 or higher events
Time frame: throughout the treatment period and for a predefined follow-up period, typically up to 12 months after treatment completion
Overall Survival (OS)
OS will be determined based on the date of death recorded in medical records or through follow-up contacts with patients or their families
Time frame: From date of first study treatment to death from any cause, assessed at 24 weeks, 48 weeks, and 72 weeks.
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