Status:
RECRUITING
Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors
Lead Sponsor:
Mayo Clinic
Conditions:
Malignant Solid Neoplasm
Metastatic Malignant Neoplasm in the Brain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by ...
Detailed Description
PRIMARY OBJECTIVE: I. To determine for patients with brain metastases meeting the inclusion criteria, whether there is an increase in the time to a composite endpoint of adverse outcomes including th...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Histological or cytological confirmation of solid tumor malignancy and/or clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings
- Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate
- Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=\< 10 metastases)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
- Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent
- Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally
Exclusion
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. \* NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Prior open neurosurgery for malignancy
- Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma
- History of whole brain radiation therapy (WBRT)
- Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible
- Leptomeningeal metastasis/disease
- A brain metastasis that is located =\< 5 mm of the optic chiasm
- Any brain metastasis \> 5 cm in size
- \> 10 brain metastases
- Indication for surgical resection of \>= 2 brain metastases
- Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab
- Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 8 2030
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03750227
Start Date
November 19 2018
End Date
November 8 2030
Last Update
December 24 2025
Active Locations (4)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
National Institutes of Neurological Disorders and Stroke, NIH
Bethesda, Maryland, United States, 20892
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905