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

August 25, 2023 updated by: Hui Liu, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Guangzhou, China, 510000
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FSRT & Bevacizumab
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)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial progression-free survival
Time Frame: 1 year
IPFS was calculated from the completion of radiotherapy until the first occurrence of either intracranial progression or death.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hui Liu, Ph.D, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

February 22, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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