Clinical trial NCT03075072: Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial
Official title: Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Metastases
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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2017-03-09
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Life Survey (symptoms and interference)
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: Through study completion, an average of 1 year
measure: Neurologic survival
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to detection of new brain metastases
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to local recurrence of treated brain tumor(s)
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to development of radiation necrosis
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to development of leptomeningeal disease
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to salvage craniotomy
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to additional radiotherapeutic treatments
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to the development of seizures
timeFrame: Through study completion, an average of 1 year
measure: Incidence and time to neurocognitive decline
timeFrame: 1 year
measure: Performance status
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Ayal Aizer, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: