NTS-WBRT in Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NTS-WBRT (normal tissue sparing whole brain radiation therapy), Memantine.
- Who it may be relevant to
- Registry conditions: Brain Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases
Overview
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
Detailed description
This is a Phase 2 trial testing the safety and effectiveness of NTS-WBRT (normal tissue sparing whole brain radiation therapy) in treating brain metastases.
NTS-WBRT is a targeted radiation therapy that further reduces radiation dose to tissue that does not need radiation therapy treatment.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
It is expected that about 41 people will take part in this research study.
Interventions
- Radiation NTS-WBRT (normal tissue sparing whole brain radiation therapy)
Radiation - Drug Memantine
Capsule, taken orally
Primary outcome measures
- 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]
Secondary outcome measures (12)
- Tumor local control Rates between NTS-WBRT+SIB and NTS-WBRT [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Intracranial- Progression Free Survival (PFS) between NTS-WBRT+SIB and NTS-WBRT [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Overall survival (OS) between NTS-WBRT+SIB and NTS-WBRT [Time frame: 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 [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Change in Mood between NTS-WBRT+SIB and NTS-WBRT [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Change in Fatigue between NTS-WBRT+SIB and NTS-WBRT [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Change in Neuroendocrine function between NTS-WBRT+SIB and NTS-WBRT [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Pure Tone Average [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Word Recognition Score [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Otoacoustic Emissions [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Alopecia Rates between NTS-WBRT+SIB and NTS-WBRT [Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months]
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 [Time frame: Up to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital Cancer Center — Boston
Identifiers
NCT: NCT05013892 · 21-356