Bevacizumab Combined With Fractionated Stereotactic Radiotherapy for 1 to 10 Brain Metastases Fro… (NCT04345146) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab Combined With Fractionated Stereotactic Radiotherapy for 1 to 10 Brain Metastases From NSCLC
China100 participantsStarted 2020-01-01
Plain-language 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-small cell lung cancer by assessing the treatment response, perilesional edema, neurological symptoms and quality of life.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 cardiovascu…