Using targeted radiation therapy before or after surgery for brain tumors
Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors
This study is testing whether giving targeted radiation therapy before or after surgery helps people with metastatic brain tumors live longer and have fewer side effects.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | bevacizumab, radiation |
| Locations | 4 sites (Scottsdale, Arizona and 3 other locations) |
| Trial ID | NCT03750227 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the effectiveness and side effects of stereotactic radiosurgery (SRS) in patients with metastatic brain tumors, comparing outcomes based on whether SRS is administered before or after surgical intervention. The primary objective is to assess the time to adverse outcomes such as local recurrence or symptomatic radiation brain necrosis. Secondary objectives include evaluating overall survival rates, patient-reported quality of life, surgical complications, and the timing of subsequent therapies. The study involves various interventions including surgery, imaging, and questionnaires to gather comprehensive data on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic brain tumors who are surgical candidates.
Not a fit: Patients with brain tumors that are not resectable or those with an ECOG performance status greater than 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with metastatic brain tumors.
How similar studies have performed: Previous studies have shown promising results with stereotactic radiosurgery in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Scottsdale, Arizona and 3 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- National Institutes of Neurological Disorders and Stroke, NIH — Bethesda, Maryland, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Yan, M.D. — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.