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

RecruitingPhase 3Ages 18 Years - anyAllSun Yat-sen University
NCT07481786 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 do

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Pathologically confirmed non-squamous non-small cell lung cancer (adenocarcinoma) * Extensive brain metastases meeting any of the following: 1-2 metastases with at least one ≥3 cm in diameter; or 3-10 metastases with at least one ≥2 cm; or 11-20 metastases * Stable extracranial disease * ECOG performance status 0-2 * Adequate bone marrow, hepatic, and renal function * Written informed consent Exclusion Criteria: * Contraindications to bevacizumab (uncontrolled hypertension, history of bleeding/thromboembolism, recent surgery, etc.) * Leptomeningeal metastasis * Prior brain radiotherapy or surgical resection of brain metastases * Significant mass effect requiring urgent neurosurgical intervention * Severe cardiovascular, vascular, or gastrointestinal disease within 6 months * Proteinuria ≥3+ or 24-hour urine protein \>1 g * Other active malignancies (except curable non-melanoma skin cancer or cervical carcinoma in situ) * Inability to comply with neurocognitive testing * Pregnancy or breastfeeding
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What it tests

  • FSRT
  • HA-WBRT-SIB
  • Bevacizumab
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Where

3 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Sun yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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