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Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI
Sponsor: Sun Yat-sen University
Summary
This study is a randomized phase III trial that aiming to investigate the role of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) guided hypofractionated radiotherapy (hypo-RT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are planned to receive hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. Patients will be randomized in a 1:1 ratio into two groups: 1. The study group will undergo adaptive dose-painting hypo-RT based on DCE-MRI. 2. The control group will undergo hypo-RT based on enhanced CT. The treatment-related toxicity, local control and long-term survival will be evaluated compared between MRI-guided and CT-guided hypo-RT.
Official title: A Randomized Controlled Phase III Study of Adaptive Hypofractionated Radiotherapy Combined With Concurrent Chemotherapy and Consolidative Immunotherapy in Locally Advanced Non-Small Cell Lung Cancer Based on Dynamic Enhanced Magnetic Resonance Imaging
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
490
Start Date
2024-08-01
Completion Date
2028-07-31
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
DCE-MRI based split-course hypo-RT
Tumor delineation will be based on DCE-MRI and CT. MRI help define the tumor boundary. Different radiation doses will be delivered based on the Ktrans value of the tumor area on DCE-MRI.
CT based split-course hypo-RT
Tumor delineation will be based on CT. The total dose for both the first and boost courses of hypo-RT to the tumor area will be constant.
Concurrent chemotherapy
Concurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2,d1.
Consolidative immunotherapy
Consolidative PD-1/PD-L1 inhibitors
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, China