Pre-operative vs. Post-operative Radiosurgery for Metastatic Brain Tumors

Overview

About this study

The purpose of this study is to determine whether there is an increase in the time of a first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients with brain metastases who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • 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).
  • ECOG Performance Status (PS) ≤ 2.             
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) or agreement to complete pre-specified MRI series and follow-up visits according to the study timeline mailing in digital copies of images as well as clinical notes.

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 HIV positive and currently receiving antiretroviral therapy.
    • Note: Patients known to be HIV positive, 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 > 5cm in size.
  • >10 brain metastases.
  • Indication for surgical resection of ≥ 2 brain metastases. 
  • Indication for long-term (anticipated greater than 4 weeks) 4mg dexamethasone equivalent of steroids or bevacizumab.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Daniel Trifiletti, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Yan, M.D.

Open for enrollment

Contact information:

Christina Todd

(507) 293-2310

Todd.Christy@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sujay Vora, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20439699

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