Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases
Metastatic Malignant Neoplasm in the Brain
About this trial
This is an interventional treatment trial for Metastatic Malignant Neoplasm in the Brain
Eligibility Criteria
Inclusion Criteria:
Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration
- The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure > 2.0 cm and < 5.0 cm.
- The maximum diameter of the lesions not to be resected must measure < 4.0 cm
- Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years
- All brain metastases must be located > 5 mm from the optic chiasm and outside the brainstem
- Patient is able to medically tolerate surgery and SRS
- Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
- History/physical examination within 14 days prior to registration
- Age >= 18
- Karnofsky performance status (KPS) >= 60 within 14 days prior to registration
- A negative urine or serum pregnancy test (in persons of childbearing potential) within =< 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months
- Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria:
Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site
- Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed
Evidence of leptomeningeal disease (LMD)
- Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal 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. 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
- Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery
- Primary histology of germ cell tumor, small cell carcinoma or lymphoma
- More than one brain metastasis planned for resection
- Inability to undergo MRI with contrast
Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS
- Note: chemotherapy and immunotherapy outside of this window are allowed
Sites / Locations
- Saint Joseph's Hospital and Medical CenterRecruiting
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- Mayo Clinic in FloridaRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Piedmont HospitalRecruiting
- Centralia Oncology ClinicRecruiting
- Northwestern UniversityRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Cancer Care Center of O'FallonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Wayne State University/Karmanos Cancer Institute
- Weisberg Cancer Treatment CenterRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- William Beaumont Hospital - TroyRecruiting
- Saint Luke's Hospital of Kansas CityRecruiting
- Billings Clinic Cancer CenterRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Renown Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- The Valley Hospital-Luckow Pavilion
- Capital Health Medical Center-HopewellRecruiting
- Valley Hospital
- Valley Health System-Hematology/Oncology
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Roswell Park Cancer InstituteRecruiting
- Mount Sinai ChelseaRecruiting
- Mount Sinai WestRecruiting
- Mount Sinai HospitalRecruiting
- Good Samaritan Hospital Medical CenterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- CaroMont Regional Medical CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Northeast Radiation Oncology CenterRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- Thomas Jefferson University HospitalRecruiting
- UPMC-Presbyterian HospitalRecruiting
- UPMC-Shadyside HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Gibbs Cancer Center-GaffneyRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- Spartanburg Medical CenterRecruiting
- MGC Hematology Oncology-UnionRecruiting
- Covenant Medical Center-LakesideRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Inova Schar Cancer Institute
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Aurora Sinai Medical CenterRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Aurora Medical Center in SummitRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (surgery, stereotactic radiosurgery)
Arm II (stereotactic radiosurgery, surgery)
Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction.
Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care.