Normal tissue sparing radiation therapy for brain metastases
Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases
This study is testing a new type of radiation therapy that aims to protect healthy brain tissue while treating brain metastases, to see if it improves quality of life for patients receiving it along with a standard medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05013892 on ClinicalTrials.gov |
What this trial studies
This Phase 2 trial evaluates the safety and effectiveness of normal tissue sparing whole brain radiation therapy (NTS-WBRT) in patients with brain metastases. The study aims to assess the quality of life and symptom burden in participants receiving NTS-WBRT alongside the standard care drug Memantine. Participants will undergo screening for eligibility, receive the treatment, and attend follow-up visits for evaluations over a maximum of two years. The trial is expected to enroll approximately 41 individuals.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a solid tumor diagnosis and clinically indicated brain metastases requiring whole brain radiation therapy.
Not a fit: Patients with brain metastases who are not clinically indicated for cranial irradiation or have a Karnofsky Performance Status below 70 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the quality of life for patients with brain metastases by reducing radiation exposure to healthy brain tissue.
How similar studies have performed: Other studies have shown promise with targeted radiation therapies, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Helen A Shih, MD, MS, MPH — Massachusetts General Hospital
- Study coordinator: Helen A Shih, MD, MS, MPH
- Email: hshih@mgh.harvard.edu
- Phone: (617) 724-9627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.