Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03750227

Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors

Led by Mayo Clinic · Updated on 2025-12-24

140

Participants Needed

4

Research Sites

624 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 surgery. 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.

CONDITIONS

Official Title

Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed or suspected solid tumor that has spread to the brain with intraparenchymal brain metastasis
  • Neurosurgeon recommends surgical removal of one brain metastasis and patient is a surgical candidate
  • Plan for stereotactic radiosurgery to all known brain lesions requiring treatment, with 10 or fewer metastases
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Provide written informed consent or have a legally authorized representative provide consent
  • Willing to attend follow-up visits either at the study site or with a local doctor and share clinical notes and imaging
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • Men or women of childbearing potential unwilling to use adequate contraception
  • Severe systemic illnesses or other diseases that would interfere with safety assessment
  • Immunocompromised patients or HIV positive patients currently on antiretroviral therapy
  • Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
  • Prior open neurosurgery for malignancy
  • Known or suspected primary germ cell tumor, small cell carcinoma, or lymphoma
  • History of whole brain radiation therapy
  • Allergy to gadolinium or presence of non-MRI-safe implants
  • Leptomeningeal metastasis or disease
  • Brain metastasis located 5 mm or less from the optic chiasm
  • Any brain metastasis larger than 5 cm
  • More than 10 brain metastases
  • Indication for surgical removal of two or more brain metastases
  • Need for long-term (over 4 weeks) high-dose steroids or bevacizumab
  • Currently enrolled in another brain metastases trial involving radiation or surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

2

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

3

National Institutes of Neurological Disorders and Stroke, NIH

Bethesda, Maryland, United States, 20892

Actively Recruiting

4

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors | DecenTrialz