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

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 published studies suggest that stereotactic radiation results
in fewer neurologic side effects than whole brain radiation. It also yields better quality of
life in this population. It remains unknown whether stereotactic radiation improves quality
of life in patients with 5-20 brain metastases relative to whole brain radiation. In this
study, the investigators seek to determine which of the two methods of study treatment
results in a better subsequent quality of life for patients with 5-20 brain metastases.

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-fifteen 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)