Clinical trial · Interventional
NTS-WBRT in Brain Metastases
Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases
NCT05013892CI-TRIAL-00108477recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Memantine | Drug | — | UNRESOLVED |
| NTS-WBRT (normal tissue sparing whole brain radiation therapy) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NTS-WBRT (normal tissue sparing whole brain radiation therapy) + Memantine
- description
- 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
- interventionNames
- Radiation: NTS-WBRT (normal tissue sparing whole brain radiation therapy)
- Drug: Memantine
Primary outcomes (2)
- measure
- Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
- timeFrame
- 4 Months
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.