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(Last updated: September 10, 2021)

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NEAREST SITE: 752 miles
University of Arizona Cancer Center-North Campus
Tucson,AZ

VISITS: Please contact research site

PHASE: III

NCT ID: NCT04588246

Stereotactic Radiotherapy Alone or with Whole Brain Radiotherapy (Excluding the Hippocampus) & a Dementia Medication for Brain Mets that Returned After Stereotactic Radiotherapy

Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year Scientific Title

Purpose
To compare the anti-cancer activity and side effects of giving stereotactic radiation therapy alone to giving it with an anti-dementia drug and whole-brain radiation therapy that avoids the hippocampus.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to their brain and who have already received stereotactic radiation therapy for brain mets.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Memantine, by mouth, once or twice a day, for 6 months</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy, 10 times over 2 weeks</li> <li class="seamTextUnorderedListItem">folowed by, stereotactic radiotherapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiotherapy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery.</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBR) typically targets the entire brain, including the hippocampus. By avoiding the hippocampus, researchers hope to lessen the side effects of WBR. </li> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery) delivers focused radiation to each metastasis (met/tumor). </li> <li class="seamTextUnorderedListItem">Memantine is a medication approved for use in people with dementia, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer that have spread to the brain.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04588246' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/brain-metastases-radiation-therapy-hippocampal-avoidance' target='_blank'>NCI Cancer Currents Blog: Tailored Radiation to Treat Brain Metastases Reduces Impact on Cognitive Function</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/side-effects-of-brain-mets-radiation/' target='_blank'>Metastatic Trial Talk: Side Effects of Radiation Therapy to the Brain</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a604006.html' target='_blank'>MedLinePlus: Memantine</a> </li></ul>
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