Trial NCT05013892
NTS-WBRT in Brain Metastases
- Phase
- Phase 2
- Sponsor
- Massachusetts General Hospital
- Conditions
- Brain Metastases
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 ≥ 70Performance status
* 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 testingLanguage
* 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)Brain metastases
* 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 therapyPregnancy
* Concurrent participation in an investigational systemic therapy protocol.
Restrictions found (4)
- Brain metastasesOutrightexclusionShow in the text
- LanguageOutrightinclusionShow in the text
- Performance statusOutrightinclusion
KPS ≥ 70
Show in the text - PregnancyConditionalexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital Cancer Center · Boston, Suffolk County