MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Combination Product: Unity-based MR-Linac guided FSRT
- Registration Number
- NCT04946019
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MR-Linac Guided Adaptive FSRT Unity-based MR-Linac guided FSRT Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine.
- Primary Outcome Measures
Name Time Method 1-year intracranial progression-free survival 1 year
- Secondary Outcome Measures
Name Time Method 1-year overall survival 1 year Rate of participants with perilesional edema of brain metastases evaluated byT2-weighted MRI 1 year Quality of life evaluated by EORTC quality of life questionnaire 1 year Objective response rate 2 months 1-year progression-free survival 1 year Dose coverage to targets 2 months Rate of patients with treatment-related adverse events evaluated by CTCAE v4.0 1 year Dose to normal organs 2 months
Trial Locations
- Locations (1)
Hui Liu
🇨🇳Guangzhou, Guangdong, China