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


Trial ID:NCT03075072

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Protocol #:16-305

877-DF-TRIAL (877-338-7425)

Condition(s):Brain Metastases


Principal Investigator:Aizer, Ayal

Site Investigator(s):Tanguturi, Shyam, Kumar
Tanguturi, Shyam, Kumar

Site Research Nurse(s):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 body)

Eligibility Requirements:
- 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)

Protocol #: 16-305

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