This phase III trial studies how well whole-brain radiotherapy or stereotactic radiosurgery works in treating patients with 5-20 malignant tumors that have spread to the brain from other parts of the body. Whole-brain radiotherapy delivers radiation to the entire brain Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether whole-brain radiotherapy or stereotactic radiosurgery works better in treating patients with 5-20 malignant tumors in the brain.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03075072.
PRIMARY OBJECTIVE:
I. To test the hypothesis that, among patients with 5-20 brain metastases, post-treatment quality of life is superior for those treated with stereotactic radiation compared to those treated with whole-brain radiotherapy (WBRT).
SECONDARY OBJECTIVES:
I. To compare the following other endpoints between patients treated with WBRT and those treated with stereotactic radiation:
Ia. All-cause mortality.
Ib. Death due to neurologic causes (defined as death due to progressive brain metastases on imaging associated with progressive neurologic symptomatology in the setting of systemic disease that has not progressed to a life-threatening nature).
Ic. Performance status.
Id. Incidence and time to detection of new brain metastases.
Ie. Incidence and time to local recurrence.
If. Incidence and time to development of radiation necrosis.
Ig. Incidence and time to development of leptomeningeal disease.
Ih. Incidence and time to progressive intracranial disease.
Ii. Incidence and time to salvage craniotomy
Ij. Incidence and time to additional radiotherapeutic treatments after the initial course (stereotactic or WBRT).
Ik. Incidence and time to the development of seizures.
Il. Incidence and time to neurologic/neurocognitive decline.
Im. Steroid use.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo WBRT daily for 10 fractions.
ARM II: Patients with lesions < 2 cm in maximum diameter undergo stereotactic radiosurgery for 1 fraction. Patients with lesions > 2.5-3 cm undergo stereotactic radiosurgery for 5 fractions.
After completion of study treatment, patients are followed up at 3 weeks and then at 2, 4, 6, 8, 10, and 12 months thereafter.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAyal Aaron Aizer
