RecruitingPhase 3NCT06545747

Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI

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


Sponsor

Sun Yat-sen University

Enrollment

490 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an adaptive radiotherapy approach — where the radiation plan is adjusted throughout treatment based on MRI scans showing how the tumor responds — for people with stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. **You may be eligible if...** - You are 18–75 years old with confirmed unresectable stage III non-small cell lung cancer - You have not received prior radiation or surgery for this cancer - You can undergo MRI scans - Your lung function, blood counts, and organ function meet required levels - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have had prior chest radiation or lung surgery - You cannot tolerate MRI scans (e.g., metal implants, severe claustrophobia) - You have poor lung function (FEV1 below 800 mL) - You have other serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDCE-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.

RADIATIONCT 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.

DRUGConcurrent chemotherapy

Concurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2,d1.

DRUGConsolidative immunotherapy

Consolidative PD-1/PD-L1 inhibitors


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, China

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NCT06545747


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