Comparative Evaluation of Two Different Radiosurgery

Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors

Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients

This is a prospective double arm phase III study to evaluate cerebral side effects following radiosurgery delivered by Gamma Knife Perfexion and Linac Based EDGE. In particular our primary objective is to evaluate rate of symptomatic radionecrosis from the two different modalities of radiosurgery.

Inclusion Criteria:

• Age 18 - 85 years
• 1 - 4 brain metastases
• Karnofsky performance status (KPS) ≥70
• RPA 1 or 2
• Histopathologically confirmation of primary solid tumor
• Estimated survival ≥ 3 months as GPA score
• Written informed consent

Exclusion Criteria:

• Prior WBRT
• Age > 85 years
• KPS < 70
• RPA 3
• Diagnosis of small cell lung cancer (SCLC) or Lymphoproliferative disease
• Use of Avastin for at least 2 months after radiosurgery
• Pregnant women