Non-small Cell Lung Cancer
Conditions
Keywords
non-small cell lung cancer, Bevacizumab, Fractionated stereotactic radiation therapy, Brain metastases
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-small cell lung cancer by assessing the treatment response, perilesional edema, neurological symptoms and quality of life.
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-small cell lung cancer by assessing the treatment response, neurological symptoms and quality of life. Patients will receive Bevacizumab(7.5mg/kg, q3w, i.v.) before and after FSRT(40Gy in 10 fractions or 30Gy in 5 fractions) to the brain metastases. The primary endpoint was intra-cranial progression-free survival (IPFS). Secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life (QOL) scores, and toxicities.
Interventions
COMBINATION_PRODUCTFSRT combined with Bevacizumab
Bevacizumab: Patients will receive Bevacizumab (7.5mg/kg, q3w, IV) before and after FSRT. Fractionated stereotactic radiotherapy(FSRT): 40 Gy/10 fractions or 30 Gy/5 fractions for GTV will be delivered to brain metastases.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial progression-free survival | 1 year | IPFS was calculated from the completion of radiotherapy until the first occurrence of either intracranial progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 1 year | — |
| progression-free survival (PFS) | 1 year | — |
| Rate of participants with perilesional edema of brain metastases evaluated by T2-weighted MRI | 1 year | — |
| Quality of life evaluated by EORTC quality of life questionnaire | 6 months | Quality of life evaluated by EORTC quality of life questionnaire(QLQ-C30 and QLQ-BN20) |
| Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0 | 1 year | — |
Countries
China
Outcome results
None listed