Status:
RECRUITING
Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 patie...
Eligibility Criteria
Inclusion
- Male or female aged between 18 and 75 years old.
- Patients must have histological or cytological confirmation of locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC).
- 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 the following criteria: Forced expiratory volume in 1 second (FEV1) ≥ 800 ml; Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 100 × 10\^9/L; Hemoglobin ≥ 9.0 g/dL; Serum creatinine clearance rate calculated by the Cockcroft-Gault formula ≥ 50 mL/min (Cockcroft and Gault 1976); Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN.
Exclusion
- Contraindications to MRI examination.
- Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study.
- Histological type of mixed small cell and non-small cell lung cancer.
- Major surgery performed within 4 weeks prior to entering the study (excluding vascular access).
- History or occurrence of autoimmune disease within the past 2 years.
- Active or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- History of primary immunodeficiency.
- History of organ transplantation requiring immunosuppressive therapy.
- Average QT interval (QTc) ≥ 470 ms calculated from 3 ECG cycles using Bazett's correction.
- Uncontrolled comorbidities, including but not limited to persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active bleeding disorder, human immunodeficiency virus (HIV), or psychiatric/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent.
- Active tuberculosis.
- Receipt of a live attenuated vaccine within 30 days prior to the start of the study.
- History of another primary malignancy within 5 years, excluding adequately treated basal or squamous cell skin cancer or in situ cervical cancer.
- Pregnant or breastfeeding women; or males and females of reproductive potential not using effective contraception.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT06545747
Start Date
August 1 2024
End Date
July 31 2028
Last Update
July 24 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, China