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Active Not Recruiting
NCT03075072
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial
Conditions: Brain Metastases
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 196
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)
Eligibility Criteria
Inclusion Criteria:
* Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible
* Five-twenty intracranial lesions must be present on MRI of the brain
* Age 18-80 years at diagnosis of brain metastases
* Karnofsky performance status of at least 70
Exclusion Criteria:
* Participants who have undergone prior radiation for brain metastases.
* Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study
* Participants who cannot undergo a brain MRI
* Participants who cannot receive gadolinium (MRI contrast)
* Participants with stage IV-V chronic kidney disease or end stage renal disease
* Participants with widespread, definitive leptomeningeal disease
* Participants with small cell lung cancer, lymphoma, or myeloma
* Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
Source: ClinicalTrials.gov (NCT03075072). StuddyBuddy aggregates publicly available trial information.