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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
490
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.
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 consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2,d1.
Consolidative PD-1/PD-L1 inhibitors
Sun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGtreatment-related G2+ respiratory toxicity
the percentage of patients who developed G2+ respiratory toxicity, including pneumonitis and proximal bronchial tree toxicity
Time frame: Recorded from the enrollment to 1 year after the completion of hypo-RT or 3 months after the completion of consolidative immunotherapy
progression-free survival rate
Time frame: 2-year
local control rate
Time frame: 2-year
overall survival rate
Time frame: 2-year
patient reported outcome assessed by QLQ-C30
assessed by QLQ-C30
Time frame: 2 year
patient reported outcome
assessed by QLQ-LC13 questionnaires
Time frame: 2 year
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