Whole brain radiation versus stereotactic radiation in patients with 5-20 brain metastases: A phase III, randomized clinical trial

Protocol # :
Brain Metastases
Disease Sites
Other Respiratory and Intrathoracic Organs
Brain and Nervous System
Unknown Sites
Principal Investigator
Aizer, Ayal
Site Investigator
Tanguturi, Shyam, Kumar
Tanguturi, Shyam, Kumar
Site Research Nurses
Mann, Eileen, Marie
Roper, Kristin
Spicer, Beverly, A.

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

Eligibility Requirements

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)