Actively Recruiting
Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI
Led by Sun Yat-sen University · Updated on 2026-04-06
490
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 75 years old.
- Histological or cytological confirmation of locally advanced, unresectable (stage III) non-small cell lung cancer.
- No prior radiation therapy or surgery.
- Expected life expectancy of at least 12 weeks.
- World Health Organization (WHO) performance status score of 0 or 1.
- Able to undergo magnetic resonance imaging (MRI) examination.
- Organ and bone marrow function meeting specified criteria: FEV1 25 800 ml; absolute neutrophil count 25 1.5 �d7 10^9/L; platelets 25 100 �d7 10^9/L; hemoglobin 25 9.0 g/dL; serum creatinine clearance 25 50 mL/min; serum bilirubin 24 1.5 times upper limit of normal; AST and ALT 24 2.5 times upper limit of normal.
You will not qualify if you...
- Contraindications to MRI examination.
- Concurrent participation in another clinical study unless observational.
- Histological type of mixed small cell and non-small cell lung cancer.
- Presence of sensitive EGFR mutations or ALK rearrangements.
- Major surgery within 4 weeks prior to study entry (excluding vascular access).
- History or occurrence of autoimmune disease within 2 years.
- Active or history of inflammatory bowel disease.
- History of primary immunodeficiency.
- History of organ transplantation requiring immunosuppressive therapy.
- Average QT interval 25 470 ms on ECG.
- Uncontrolled comorbidities including infection, heart failure, hypertension, angina, arrhythmia, peptic ulcer, bleeding disorder, HIV, or psychiatric/social issues limiting compliance.
- Active tuberculosis.
- Receipt of live attenuated vaccine within 30 days prior to study.
- History of another primary malignancy within 5 years except treated skin or cervical cancer.
- Pregnant or breastfeeding women or individuals not using effective contraception.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
B
Bo Qiu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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