Status:
COMPLETED
Bevacizumab Combined With Fractionated Stereotactic Radiotherapy for 1 to 10 Brain Metastases From NSCLC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase II randomized study is to determine the efficacy and safety of Bevacizumab combined with fractionated stereotactic radiation therapy(FSRT) in patients with 1 to 10 brain metastases in non-s...
Detailed Description
This Phase II randomized study is to determine the efficacy and safety of Bevacizumab combined with fractionated stereotactic radiation therapy(FSRT) in patients with 1 to 10 brain metastases in non-s...
Eligibility Criteria
Inclusion
- aged ≥18 years old;
- histologically confirmed NSCLC;
- 1-10 BMs on contrast-enhanced MRI;
- stable extracranial disease status at the time of enrollment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04345146
Start Date
January 1 2020
End Date
March 31 2023
Last Update
August 28 2023
Active Locations (1)
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1
Sun Yat-sen University
Guangzhou, China, 510000