Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07481786

Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases

Led by Sun Yat-sen University · Updated on 2026-04-06

220

Participants Needed

3

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase 3, randomized, controlled clinical trial comparing two brain-directed treatment strategies for adult patients with extensive brain metastases from lung adenocarcinoma. The trial compares fractionated stereotactic radiotherapy combined with bevacizumab (FSRT-Bev) versus hippocampus-avoidant whole-brain radiotherapy with simultaneous integrated boost (HA-WBRT-SIB). The main objectives are to evaluate intracranial tumor control and preservation of neurocognitive function . Patients will be randomly assigned in a 1:1 ratio to receive either FSRT plus bevacizumab or HA-WBRT-SIB. In the experimental group, FSRT is delivered to visible brain tumors over 5 daily treatments (total 30 Gy, 6 Gy per fraction). Bevacizumab is given intravenously every 3 weeks for 4 cycles. In the control group, patients receive hippocampus-avoidant whole-brain radiation (25 Gy) with a simultaneous dose boost to metastatic lesions (40 Gy total) over 10 daily treatments.

CONDITIONS

Official Title

Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Pathologically confirmed non-squamous non-small cell lung cancer (adenocarcinoma)
  • Extensive brain metastases defined as 1-2 metastases with at least one 3 cm or larger; or 3-10 metastases with at least one 2 cm or larger; or 11-20 metastases
  • Stable extracranial disease
  • ECOG performance status of 0 to 2
  • Adequate bone marrow, liver, and kidney function
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to bevacizumab such as uncontrolled hypertension, history of bleeding or blood clots, recent surgery
  • Presence of leptomeningeal metastasis
  • Previous brain radiotherapy or brain metastases surgery
  • Severe mass effect requiring urgent neurosurgery
  • Severe cardiovascular, vascular, or gastrointestinal disease within the last 6 months
  • Proteinuria of 3+ or urine protein over 1 gram in 24 hours
  • Other active cancers except curable non-melanoma skin cancer or cervical carcinoma in situ
  • Unable to comply with neurocognitive testing
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Actively Recruiting

2

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

3

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China, 510405

Actively Recruiting

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Research Team

H

Hui Liu

CONTACT

B

Bo Qiu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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