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

StatusRecruiting
PhasePhase 3
Started2026-03-20
View on ClinicalTrials.gov ↗

Amendment history

2026-04-03
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-03-15→confirmed 2026-03-20
Study sitesdetails revised at 3 of 3 sites
2026-03-15
Original filing
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.
Trial Details
NCT Number NCT07481786
Lead Sponsor Sun Yat-sen University
Conditions Lung Adenocarcinoma, Brain Metastases, Radiotherapy, Intensity-Modulated, Bevacizumab, Whole-Brain Radiotherapy
Enrollment 220 participants
Start Date 2026-03-20
Primary Completion 2029-09-15 (estimated)
Study Completion 2029-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-06