Brain Metastases
Conditions
Keywords
Brain metastases, Brain metastasis, Lung cancer, Melanoma, Breast cancer, Kidney cancer, Renal cell carcinoma, Stereotactic radiation, Stereotactic radiosurgery, SRS, Stereotactic, Whole brain radiation, WBRT, Hippocampal avoidance, Hippocampal sparing, Hippocampal, Hippocampus, Radiation, Quality of Life, Neurocognitive, Neurocognition, Survival, Salvage, MDASI, Chemotherapy, Recurrence
Brief summary
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)
Detailed description
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.
Interventions
RADIATIONWhole brain radiation
Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.
RADIATIONStereotactic radiation (SRS)
Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.
Sponsors
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Survey (symptoms and interference) | 6 months | Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurologic survival | Through study completion, an average of 1 year | Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic) |
| Incidence and time to detection of new brain metastases | Through study completion, an average of 1 year | Radiographic assessment of first appearance of new brain metastases |
| Incidence and time to local recurrence of treated brain tumor(s) | Through study completion, an average of 1 year | Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation |
| Incidence and time to development of radiation necrosis | Through study completion, an average of 1 year | Radiographic assessment of first appearance of radiation necrosis |
| Incidence and time to development of leptomeningeal disease | Through study completion, an average of 1 year | Radiographic assessment of first appearance of leptomeningeal disease |
| Overall survival | Through study completion, an average of 1 year | Clinical Parameter |
| Incidence and time to additional radiotherapeutic treatments | Through study completion, an average of 1 year | Clinical assessment of first use of salvage brain-directed radiation |
| Incidence and time to the development of seizures | Through study completion, an average of 1 year | Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review |
| Incidence and time to neurocognitive decline | 1 year | Scale |
| Performance status | Through study completion, an average of 1 year | Questionnaire - Karnofsky performance status |
| Incidence and time to salvage craniotomy | Through study completion, an average of 1 year | Clinical assessment of first use of neurosurgical resection as salvage therapy |
Countries
United States
Outcome results
None listed