Recruiting
Phase 2

NTS-WBRT

Sponsor:

Massachusetts General Hospital

Code:

NCT05013892

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Memantine

Study Details

Brief summary:

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

Conditions

Brain Metastases

Study ID

NCT05013892

Start date

Feb 8, 2022

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

41 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NTS-WBRT (normal tissue sparing whole brain radiation therapy) + Memantine

Participants will be randomly assigned to NTS-WBRT (normal tissue sparing whole brain radiation therapy) administration group and receive:

  • NTS-WBRT for 5 days (Monday-Friday) for either 2 or 3 weeks.
  • Memantine per standard of care, 1-2x daily for up to 24 weeks Specific participant administration schedules will be determined by study doctor

Interventions

NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Radiation

Memantine

Capsule, taken orally

Primary outcome measure

  • Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy) [ Time Frame: 4 Months ]
  • Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy) [ Time Frame: 4 Months ]

Central Contacts and Locations

Central contacts

Helen A Shih, MD, MS, MPH

(617) 724-9627hshih@mgh.harvard.edu

Locations

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Helen A Shih, MD,MS,MPH

617-724-9627hshih@mgh.harvard.edu

Principal Investigator:

Helen A Shih, MD, MS, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Brain Metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-16.