Single Fraction Stereotactic Radiosurgery or Three to Five Fraction Stereotactic Radiosurgery in Treating Patients With Brain Metastasis That Has Been Removed by Surgery
This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body (brain metastases) and has been removed by surgery (resected). Single fraction 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. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
PRE-REGISTRATION:
* Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
* Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging \[MRI\]) at the time of screening.
o Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.
* Unresected lesions must measure \< 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept.
o Note: The metastases size restriction does not apply to the resected brain metastasis.
* One brain metastasis must be completely (gross total resection) resected =\< 30 days prior to pre-registration.
o NOTE: May not have had resection of more than one brain metastasis.
* The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI.
* Resection cavity must measure \< 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained =\< 30 days prior to pre-registration.
* Karnofsky performance status of \>= 60.
* For women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to pre-registration is required.
* Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
* Ability to complete an MRI of the head with contrast.
* The brain metastasis must be located \> 5 mm of the optic chiasm; the brain metastasis must be located outside the brainstem (i.e. not inside the brainstem).
* Must not have any prior whole brain radiation therapy.
* Past radiosurgery to other lesions is allowed.
o NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol).
* May not have primary germ cell tumor, small cell carcinoma, or lymphoma.
* No evidence of leptomeningeal metastasis (LMD).
o NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.
* Must be fluent in English, Spanish, or French.
REGISTRATION:
• Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA).
Primary outcome measure(s)
Surgical bed recurrence-free survival (SB-RFS) — From the time of randomization up to 2 years post radiation Surgical bed control is defined as the absence of new nodular contrast enhancement in the surgical bed. In other words, a surgical bed recurrence-free survival (SB-RFS) event is defined as radiographic evidence of a new contrast-enhancing lesion (specifically any new progressive enhancing nodularity) at the site of the surgical resection. Will use a stratified log-rank test that compares and will report the median SB-RFS times between the single fraction stereotactic radiosurgery (SSRS) and fractionated stereotactic radiosurgery (FSRS) arms while adjusting for the stratification factors.
Trial sites (232)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Anchorage Radiation Therapy Center
Anchorage
Alaska
Banner MD Anderson Cancer Center
Gilbert
Arizona
Banner Thunderbird Medical Center
Glandale
Arizona
Banner-University Medical Center Phoenix
Phoenix
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Arizona
Mayo Clinic in Arizona
Scottsdale
Arizona
University of Arizona Cancer Center-North Campus
Tucson
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
UC San Diego Moores Cancer Center
La Jolla
California
Los Angeles County-USC Medical Center
Los Angeles
California
USC / Norris Comprehensive Cancer Center
Los Angeles
California
Epic Care Cyberknife Center
Walnut Creek
California
University of Colorado Hospital
Aurora
Colorado
UCHealth Memorial Hospital Central
Colorado Springs
Colorado
Yale University
New Haven
Connecticut
Helen F Graham Cancer Center
Newark
Delaware
Beebe Health Campus
Rehoboth Beach
Delaware
Boca Raton Regional Hospital
Boca Raton
Florida
Morton Plant Hospital
Clearwater
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables
Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
Florida
Mayo Clinic in Florida
Jacksonville
Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Florida
Moffitt Cancer Center
Tampa
Florida
Emory University Hospital Midtown
Atlanta
Georgia
Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
Emory Saint Joseph's Hospital
Atlanta
Georgia
Saint Alphonsus Cancer Care Center-Boise
Boise
Idaho
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Idaho
Kootenai Health - Coeur d'Alene
Coeur d'Alene
Idaho
Walter Knox Memorial Hospital
Emmett
Idaho
Idaho Urologic Institute-Meridian
Meridian
Idaho
Saint Alphonsus Cancer Care Center-Nampa
Nampa
Idaho
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Idaho
Kootenai Cancer Clinic
Sandpoint
Idaho
Illinois CancerCare-Bloomington
Bloomington
Illinois
Illinois CancerCare-Canton
Canton
Illinois
+ 192 more sites — see the full list on the official registry below.
More Alliance for Clinical Trials in Oncology trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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