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RECRUITING
NCT07193641
PHASE2

A Study on Using SFRT With Standard Treatment for Oligoprogressive NSCLC

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Single-Arm Phase II Clinical Trial of Standard Systemic Therapy Combined With Spatial Fractionated Radiotherapy (SFRT) for Oligoprogressive Non-small Cell Lung Cancer (NSCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-06-15

Completion Date

2028-06-15

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

RADIATION

Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT)

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.

DRUG

The systemic therapy

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.

Locations (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China