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Clinical Trials in Israel / NCT05438212
Active, not recruiting Phase 3

Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases

NCT05438212 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2022-10-24
Last updated
2026-09-10

Condition(s) studied

Metastatic Malignant Neoplasm in the Brain

Investigational drug(s) / intervention(s)

Brain SurgeryQuality-of-Life AssessmentQuestionnaire AdministrationStereotactic Radiosurgery

Brain Surgery: Undergo surgery per standard of care

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Stereotactic Radiosurgery: Undergo stereotactic radiosurgery

Study summary

This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation to target tumors and minimizes effect on normal surrounding brain tissue. The combination of surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. This study investigates whether treating with SRS before surgery may be better than SRS after surgery in reducing the possibility of the tumor coming back, reducing or preventing the cancer from spreading to other areas of the brain and reducing the risk of scarring on the brain from radiation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 any lesions which will not be resected must be =\< 4.0 cm in maximum diameter * 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 * 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

Primary outcome measure(s)

Trial sites (216)

FacilityCityRegionStatus
Saint Joseph's Hospital and Medical Center Phoenix Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Kaiser Permanente-Anaheim Anaheim California
Sutter Auburn Faith Hospital Auburn California
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
Kaiser Permanente-Bellflower Bellflower California
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Memorial Medical Center Modesto California
Kaiser Permanente-Ontario Ontario California
Saint Joseph Hospital - Orange Orange California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
Stanford Cancer Institute Palo Alto Palo Alto California
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
Sutter Roseville Medical Center Roseville California
Sutter Medical Center Sacramento Sacramento California
University of California Davis Comprehensive Cancer Center Sacramento California
California Pacific Medical Center-Pacific Campus San Francisco California
UCSF Medical Center-Parnassus San Francisco California
Sutter Pacific Medical Foundation Santa Rosa California
Sutter Solano Medical Center/Cancer Center Vallejo California
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
UM Sylvester Comprehensive Cancer Center at Doral Doral Florida
Mayo Clinic in Florida Jacksonville Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Miami Cancer Institute Miami Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
Moffitt Cancer Center-International Plaza Tampa Florida
Moffitt Cancer Center - McKinley Campus Tampa Florida
Moffitt Cancer Center Tampa Florida
Moffitt Cancer Center at Wesley Chapel Wesley Chapel Florida
Grady Health System Atlanta Georgia
Emory University Hospital Midtown Atlanta Georgia
Piedmont Hospital Atlanta Georgia
Emory University Hospital/Winship Cancer Institute Atlanta Georgia
Emory Saint Joseph's Hospital Atlanta Georgia
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
Queen's Cancer Cenrer - POB I Honolulu Hawaii

+ 176 more sites — see the full list on the official registry below.

More NRG Oncology trials in Israel

Official registry record

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.

View NCT05438212 on ClinicalTrials.gov ↗ ← All trials in Israel