Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Brain Metastases

Treatments: Radiation: Whole brain radiation; Radiation: Stereotactic radiation (SRS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03075072

16-305

Details and patient eligibility

About

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)

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Whole Brain Radiation

Active Comparator group

Description:

* MRI will be performed prior to radiation is administered * A hippocampal sparing approach will be used when possible * Dose will be 30 Gy in 10 fractions

Treatment:

Radiation: Whole brain radiation

Stereotactic Radiation (SRS)

Experimental group

Description:

* MRI will be performed prior to radiation is administered * Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)

Treatment:

Radiation: Stereotactic radiation (SRS)