Phase 3 Trial Comparing Bevacizumab Plus Fractionated Stereotactic Radiotherapy Versus Hippocampus-Avoidant Whole-Brain Radiotherapy in Adults with Extensive Brain Metastases from Lung Adenocarcinoma Evaluating Brain Tumor Control and Cognitive Function

What this Trial Is About

Researchers are evaluating two different brain-directed treatment strategies for adults with extensive brain metastases from lung adenocarcinoma in a phase 3 randomized clinical trial. The study aims to compare fractionated stereotactic radiotherapy combined with bevacizumab FSRT-Bev against hippocampus-avoidant whole-brain radiotherapy with simultaneous integrated boost HA-WBRT-SIB. The goal is to assess which approach better controls intracranial tumors and preserves neurocognitive function. Participants are randomly assigned to one of two groups. The experimental group receives FSRT targeting visible brain tumors over 5 daily sessions with a total dose of 30 Gy, alongside bevacizumab given intravenously every 3 weeks for 4 cycles starting one week before radiotherapy. The control group undergoes hippocampus-avoidant whole-brain radiotherapy at 25 Gy with a simultaneous boost to metastatic lesions totaling 40 Gy over 10 daily treatments. Throughout the study, participants undergo regular assessments including neurocognitive tests like the Hopkins Verbal Learning Test-Revised, Controlled Oral Word Association Test, and Trail Making Tests. Researchers monitor intracranial progression-free survival over 18 months and neurocognitive function failure at 6 months post-radiotherapy. Additional evaluations include overall survival, quality of life, and safety over 18 months. The trial involves continuous monitoring and follow-up to evaluate treatment effects and participant well-being.

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