Status:
RECRUITING
Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
Lead Sponsor:
Sun Yat-sen University
Conditions:
MRI-guided Adaptive Radiotherapy
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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)...
Detailed Description
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 NSCLC patients with brain metastas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06582940
Start Date
March 1 2024
End Date
March 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060