An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Frameless Stereotactic Radiosurgery with or without Margins in Treating Brain Metastases in Cancer Patients
Trial Status: active
This randomized phase II trial studies how well frameless stereotactic radiosurgery with or without margins works in treating patients with cancer that has spread to the brain. Frameless 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.
Inclusion Criteria
Adult patients (>= 18 years old) with an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and a life expectancy of 3 months or more
Histologically confirmed systemic malignancy with gadolinium contrast-enhanced magnetic resonance imaging (MRI) scan demonstrating 1-5 newly diagnosed intraparenchymal brain metastases
Well-circumscribed, measurable intraparenchymal brain lesion(s) with maximum tumor diameter =< 3.0 cm; if multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter; at least one lesion must be >= 0.5 cm in maximum diameter to be considered measurable disease
Negative urine or serum pregnancy test done =< 21 days prior to computed tomography (CT) simulation, for women of childbearing potential only
Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria
Diagnosis of hematologic malignancy
Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts)
Diagnosis of leptomeningeal disease
Prior cranial radiotherapy within 90 days of months of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
Prior history of pseudoprogression or radionecrosis from cranial radiotherapy
Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 72 hours of SRS; hormonal therapy is permitted; for Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 72 hours of SRS; patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled
I. To evaluate the non-inferiority of frameless linear accelerator (LINAC)-based stereotactic radiosurgery (SRS) using 0 mm gross tumor volume (GTV) to planning target volume (PTV) margins (experimental arm) compared to 2 mm GTV to PTV margins (standard arm) in local progression free survival (PFS) at 6 months in the treatment of intact brain metastases.
SECONDARY OBJECTIVES:
I. To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation necrosis and pseudoprogression.
II. To compare rates of local PFS at 1 year and 2 years.
III. To compare local failure cumulative incidence and rates at 6 months, 1 year and 2 years.
IV. To compare rates of overall survival (OS) at 6 months, 1 year and 2 years.
V. To compare rates of acute (within 90 days of SRS) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 central nervous system (CNS) grade 2+ and grade 3+ toxicities.
VI. To compare rates of late (greater than 90 days from SRS) CTCAE v4.0 CNS grade 2+ and grade 3+ toxicities.
VII. To compare rates of distant intracranial failure.
VIII. To compare rates of salvage therapy for any intracranial failure.
IX. To determine association between volume of tissue receiving 10 gray (V10Gy) and volume of tissue receiving 12 gray (V12Gy) all tissue, whole brain and normal brain parameters and risk of radionecrosis or pseudoprogression.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (EXPERIMENTAL): Patients undergo frameless LINAC-based stereotactic radiosurgery without GTV to PTV margins over 1-5 days.
ARM II (STANDARD): Patients undergo frameless LINAC-based stereotactic radiosurgery with GTV to PTV margins over 1-5 days.
After completion of study treatment patients are followed up at 2 weeks, 6 weeks, 3 months, and then every 3 months for 2 years.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
