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NOT YET RECRUITING
NCT07505979
PHASE2

SMART Trial: Cognitive Sparing Brain Radiotherapy for Multiple Brain Metastases

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

The goal of this phase II randomized trial is to determine if Stereotactic Radiosurgery (SRS) or Cognitive Sparing WBRT (CS-WBRT) better preserves neurocognitive function than standard Hippocampal Avoidance WBRT (HA-WBRT) in patients with multiple brain metastases ( $\\ge6$ lesions). The main questions it aims to answer are: * Which treatment best preserves cognitive function (memory and executive tasks) at 6 months post-intervention? * Can sparing the left hippocampus and corpus callosum (CS-WBRT) or using focal SRS reduce cognitive decline compared to bilateral sparing? Comparison Groups Researchers will compare three arms to evaluate their impact on cognition and disease control: * Arm A (SRS): Focal high-dose radiation (15-20 Gy in 1 fraction) to intracranial lesions. * Arm B (CS-WBRT): Whole-brain radiation (30 Gy in 10 fractions) sparing the left hippocampus and corpus callosum plus Memantine. * Arm C (HA-WBRT): Whole-brain radiation (30 Gy in 10 fractions) with bilateral hippocampal avoidance plus Memantine. Participant Tasks Participants will: * Complete neurocognitive and neuropsychological tests (HVLT-R, TMT, COWAT, CANTAB) at baseline and follow-up. * Undergo contrast-enhanced brain MRI for planning and tracking tumor progression. * Take Memantine HCL daily for 24 weeks if assigned to the WBRT arms (B or C). * Provide blood samples for biomarker and genetic analysis (e.g., APOE, Tau). * Undergo olfactory function testing and complete quality-of-life questionnaires.

Official title: Stereotactic RadioSurgery Versus Memantine Plus Cognitive Sparing or Hippocampal Avoidance Whole Brain RadioTherapy for Multiple Brain Metastases (SMART): A Phase II Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-04

Completion Date

2031-04

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

RADIATION

SRS

Focal high-dose radiation (15-20 Gy in 1 fraction) to intracranial lesions

RADIATION

CS-WBRT

Conformal Whole Brain Radiotherapy 3000 cGy in 10 fractions with Left Hippocampal Avoidance \& Corpus Callosum Sparing using RapidArc

RADIATION

HA-WBRT

Conformal Whole Brain Radiotherapy 3000 cGy in 10 fractions with Bilateral Hippocampal Avoidance using RapidArc