NTS-WBRT in Brain Metastases

NCT05013892 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 21-356
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

Brain Metastases

Outcome Measures

Primary Outcomes (2)

• Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy)

  Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.

  4 Months

• Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy)

  Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.

  4 Months

Secondary Outcomes (12)

• Tumor local control Rates between NTS-WBRT+SIB and NTS-WBRT

  baseline, 2, 4, 6, 9, 12, 18 and 24 months

• Intracranial- Progression Free Survival (PFS) between NTS-WBRT+SIB and NTS-WBRT

  baseline, 2, 4, 6, 9, 12, 18 and 24 months

• Overall survival (OS) between NTS-WBRT+SIB and NTS-WBRT

  The date of randomization to the date of death, or otherwise censored at the last follow-up date for patients still alive up to 24 months

• Change in Neurocognitive function between NTS-WBRT+SIB and NTS-WBRT

  baseline, 2, 4, 6, 9, 12, 18 and 24 months

• Change in Mood between NTS-WBRT+SIB and NTS-WBRT

  baseline, 2, 4, 6, 9, 12, 18 and 24 months

Study Arms (1)

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

EXPERIMENTAL

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

Radiation: NTS-WBRT (normal tissue sparing whole brain radiation therapy); Drug: Memantine

Interventions

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

Radiation

Also known as: Radiation Therapy

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

Memantine DRUG

Capsule, taken orally

Also known as: Namenda, Namenda XR, Namenda XR Titration Pack

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy; Memantine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Helen A Shih, MD, MS, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen A Shih, MD, MS, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 19, 2021
• Study Start: February 8, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)