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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Prospective, Phase II Study of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy in Patients With 1 to 10 Brain Metastases From Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345146
• Other study ID #: GASTO-1053
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non-small Cell Lung Cancer

Intervention

Combination Product:
• FSRT 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.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival (OS)		1 year
Secondary	progression-free survival (PFS)		1 year
Secondary	Rate of participants with perilesional edema of brain metastases evaluated by T2-weighted MRI		1 year
Secondary	Quality of life evaluated by EORTC quality of life questionnaire	Quality of life evaluated by EORTC quality of life questionnaire(QLQ-C30 and QLQ-BN20)	6 months
Secondary	Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0		1 year