Normal tissue sparing radiation therapy for brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.