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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.
Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Quality of Life Survey (symptoms and interference)
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Time frame: 6 months
Overall survival
Clinical Parameter
Time frame: Through study completion, an average of 1 year
Neurologic survival
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)
Time frame: Through study completion, an average of 1 year
Incidence and time to detection of new brain metastases
Radiographic assessment of first appearance of new brain metastases
Time frame: Through study completion, an average of 1 year
Incidence and time to local recurrence of treated brain tumor(s)
Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation
Time frame: Through study completion, an average of 1 year
Incidence and time to development of radiation necrosis
Radiographic assessment of first appearance of radiation necrosis
Time frame: Through study completion, an average of 1 year
Incidence and time to development of leptomeningeal disease
Radiographic assessment of first appearance of leptomeningeal disease
Time frame: Through study completion, an average of 1 year
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Incidence and time to salvage craniotomy
Clinical assessment of first use of neurosurgical resection as salvage therapy
Time frame: Through study completion, an average of 1 year
Incidence and time to additional radiotherapeutic treatments
Clinical assessment of first use of salvage brain-directed radiation
Time frame: Through study completion, an average of 1 year
Incidence and time to the development of seizures
Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review
Time frame: Through study completion, an average of 1 year
Incidence and time to neurocognitive decline
Scale
Time frame: 1 year
Performance status
Questionnaire - Karnofsky performance status
Time frame: Through study completion, an average of 1 year