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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.

• - The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava) - A cavity over 2cm in diameter of primary tumor or metastasis.

• - Bleeding tendency or coagulation disorder.

• - Hemoptysis (1/2 teaspoon blood/day) happened within 1 month.

• - The use of full-dose anticoagulation within the past 1 month.

• - Severe vascular disease occurred within 6 months.

• - Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months.

• - 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.

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer. Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine. The primary end point is 1-year intracranial progression-free survival. The secondary end points are objective response rate, 1-y PFS, 1-y OS, perilesional edema of brain metastases, quality of life, safety of treatment, dose coverage of targets and dose to normal organs.

Arms

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