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1

Proton Craniospinal Irradiation for Metastatic Breast Cancer with Leptomeningeal Metastasis

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of proton craniospinal irradiation (pCSI), an experimental radiation therapy, and involved-field radiation therapy (IFRT).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the leptomeninges (leptomeningeal metastasis or leptomeningeal disease) who have not yet received treatment for leptomeningeal metastasis. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Involved-field radiation therapy (IFRT)</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Proton craniospinal irradiation (pCSI), 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the fluid surrounding the brain (cerebrospinal fluid or CSF).</li> <li class="seamTextUnorderedListItem">Radiation therapy (RT) uses high energy x-rays to kill cancer cells and shrink tumors.</li> <li class="seamTextUnorderedListItem">Involved-field radiation therapy (IFRT) is standard of care radiation that uses x-rays to treat specific areas of leptomeningeal metastases (LM) and to reduce and/or prevent symptoms.</li> <li class="seamTextUnorderedListItem">Proton craniospinal irradiation (pCSI) uses protons which may be more accurate than x-rays.</li> <li class="seamTextUnorderedListItem">pCSI may also treat the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06500481' target='_blank'>ClinicalTrials.gov</a> </li></ul>
1

Proton Craniospinal Irradiation for Metastatic Breast Cancer with Leptomeningeal Metastasis

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)
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Nearest Location:
1 miles
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, NY

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Visits:
10 visits within 2 weeks

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ClinicalTrials.gov: NCT06500481

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Phase III

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