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

Launched by MAYO CLINIC · Nov 20, 2018

Keywords

ClinConnect Summary

**Clinical Trial Summary:**

This clinical trial is looking at the best way to use a treatment called stereotactic radiosurgery (SRS) for patients with brain tumors that have spread from other parts of the body. The trial compares giving this specialized form of radiation either before or after surgery to remove the tumor. SRS targets the tumor with a high dose of radiation while minimizing damage to nearby healthy tissue. Researchers want to understand how effective this treatment is and what side effects it may cause.

To participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of a solid tumor that has spread to the brain. You should also be planning to have surgery to remove one brain tumor, as recommended by a neurosurgeon. The trial is open to patients with up to 10 brain metastases (tumors) and who have a good level of health. If you join the study, you will receive treatment according to the trial's plan and attend follow-up visits to monitor your health. It’s important to note that certain health conditions or previous treatments may prevent you from participating. This trial is currently recruiting participants, and your involvement could help improve treatment options for others with similar conditions in the future.

Gender

ALL

Eligibility 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