MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Combination Product: Unity-based MR-Linac guided FSRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04946019

GASTO-1075

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
• Other not suitable conditions determined by the investigators

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

MR-Linac Guided Adaptive FSRT

Experimental group

Description:

Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine.

Treatment:

Combination Product: Unity-based MR-Linac guided FSRT