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SMART Trial: Cognitive Sparing Brain Radiotherapy for Multiple Brain Metastases

NCT07505979 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Brain Metastases From Solid Tumors

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-04-30
Completion
2031-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07505979 on ClinicalTrials.gov