NTS-WBRT in Brain Metastases

Recruiting now · Phase 2

Conditions studied: Brain Metastases

In brief

This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT). This research study involves: * NTS-WBRT (normal tissue sparing whole brain radiation therapy) * Memantine standard of care drug

Key facts

Study ID

NCT05013892

Run by

Massachusetts General Hospital

People needed

41

Starts

2022-02-08

Expected to finish

2027-12-31

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy
• Age ≥ 18
• Karnofsky Performance Status ≥ 70
• Prior stereotactic radiosurgery (SRS) permissible per physician discretion
• Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy.
• Prior partial brain radiation therapy permissible if target volume < 50% brain and per physician discretion
• Expectant > 6 months survival
• Ability to understand and the willingness to sign a written informed consent document.
• Fluency in English, able to complete questionnaires and neurocognitive testing
• Ability to undergo MRI with gadolinium examination
• Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion
• Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians
• Negative pregnancy test for premenopausal women

You may not qualify if…

• Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)
• Prior whole brain radiation therapy
• Pre-existing or current use of memantine or other NMDA antagonists
• Known allergy to contrast used in imaging studies and/or inability to have MRI imaging
• Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy
• Concurrent participation in an investigational systemic therapy protocol.

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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