Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial

Description

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)This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life. In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently pub

Trial Eligibility

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)

Study Info

Interventions

Locations Recruiting

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