Bevacizumab Combined With Fractionated Stereotactic Radiotherapy for 1 to 10 Brain Metastases From NSCLC

NCT04345146 | Completed Phase 2

• 1 other identifier: GASTO-1053
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer; Bevacizumab; Fractionated stereotactic radiation therapy; Brain metastases

Outcome Measures

Primary Outcomes (1)

• Intracranial progression-free survival

  IPFS was calculated from the completion of radiotherapy until the first occurrence of either intracranial progression or death.

  1 year

Secondary Outcomes (5)

• 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

• Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0

  1 year

Study Arms (1)

FSRT & Bevacizumab

EXPERIMENTAL

Patients will receive Bevacizumab before and after FSRT: daily FSRT(40Gy in 10 fractions or 30Gy in 5 fractions) to the brain metastases with Bevacizumab(7.5mg/kg, q3w, IV)

Combination Product: FSRT combined with Bevacizumab

Interventions

FSRT combined with Bevacizumab COMBINATION_PRODUCT

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.

FSRT & Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥18 years old;
• histologically confirmed NSCLC;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, 510000, China

Location

Related Publications (25)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hui Liu, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: April 14, 2020
• Study Start: January 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)