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Clinical Trials in China / NCT06582940
Recruiting Phase 2

Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis

NCT06582940 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2024-03-01
Last updated
2025-11-17

Condition(s) studied

MRI-guided Adaptive RadiotherapyNon-small Cell Lung CancerBrain Metastasis

Investigational drug(s) / intervention(s)

MRI-guided adaptive SRTConventional SRT

MRI-guided adaptive SRT: MRI-guided online adaptive SRT (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. MRI will be acquired.

Conventional SRT: Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired.

Study summary

This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 18-75 years * Histologically or cytologically confirmed non-small cell lung cancer * 1-10 metastases on contrast-enhanced MRI * Radiotherapy for extracranial lesions is permitted * Tyrosine kinase inhibitors (TKI) are permitted in patients with progression of * intracranial metastases during previous TKI therapy * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN * Informed-consent Exclusion Criteria: * Small cell carcinoma of lung * Intracranial metastases needed surgical decompression * Patients with contraindications for MRI * Previous radiotherapy or excision for intracranial metastases * Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months * Uncontrolled hypertension (systolic \> 150mmHg and/or diastolic \> 100mmHg) * Major surgery within 28 days or minor surgery or needle biopsy within 48 hours * Urine protein 3-4+, or 24h urine protein quantitative \>1g * Severe uncontrolled disease * Uncontrollable seizure or psychotic patients without self-control ability * Women in pregnancy, lactation period * Other not suitable conditions determined by the investigators

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06582940 on ClinicalTrials.gov ↗ ← All trials in China