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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

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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