Investigating Two Treatments for Brain Metastases to Improve Patient Outcomes

Recruiting · Phase 3 · Brain Metastases · 26 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial looks at two different ways to treat brain metastases, which are cancer spots that have spread to the brain. One method is called stereotactic radiosurgery (SRS), a precise treatment that targets small areas in the brain. The other method combines whole brain radiation therapy with a drug called memantine, which helps with memory problems. The goal is to find out which method is better for controlling cancer and improving patients' lives.

The trial's ID is NCT03550391. This is a Phase 3 trial, which means it is looking at how well the treatments work and how safe they are. It involves about 206 participants. The treatment with memantine is not FDA-approved, but the trial is regulated, and the device used is FDA-regulated.

Who can join

Adults aged 18 and older can join if they have 5 or more brain metastases confirmed by a recent MRI. They must have a specific type of cancer and be able to complete quality of life questionnaires. Some people, like those who are pregnant or have certain health conditions, cannot participate. The trial team will confirm eligibility.

Condition

Brain Metastases

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly assigned to one of two groups. One group will receive whole brain radiation therapy with memantine, while the other group will get stereotactic radiosurgery. Everyone will receive treatment, but the specific type will depend on which group they are in. Memantine will be given in increasing doses.