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Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
RECRUITINGPhase 2Sponsored by Sun Yat-sen University
Actively Recruiting
PhasePhase 2
SponsorSun Yat-sen University
Started2024-03-01
Est. completion2026-03-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06582940
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
Age: 18 Years – 75 YearsHealthy volunteers accepted
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
Conditions5
Brain MetastasisCancerLung CancerMRI-guided Adaptive RadiotherapyNon Small Cell Lung Cancer
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Actively Recruiting
PhasePhase 2
SponsorSun Yat-sen University
Started2024-03-01
Est. completion2026-03-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06582940