Comparative Evaluation of Two Different Radiosurgery

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

Detailed Description
-----------------
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.

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

Conditions
-----------------
Metastases to Brain

Intervention / Treatment
-----------------
* Radiation: Radiosurgery with Gamma Knife Perfexion
* Radiation: Linac-based Radiosurgery with EDGE


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiosurgery with Gamma Knife Perfexion<br>A single dose of 24 Gy at 50% isodose will be prescribed at metastases with diameter ≤ 20 mm, while a dose of 20 Gy at 50% isodose will be prescribed for metastases with diameter 21-30 mm | Radiation: Radiosurgery with Gamma Knife Perfexion<br>* Gamma Knife Radiosurgery is a very precise form of therapeutic radiology. Even though it is called surgery, a Gamma Knife procedure does not involve actual surgery but it uses 192 isocentric beams of highly-focused gamma rays (60-Co) to treat small to medium size lesions. Minimum beam size is 4 mm. This procedure is frame based.<br>|
| Active Comparator: Linac-based Radiosurgery with EDGE<br>A single dose of 24 Gy will be prescribed at mean dose to PTV at metastases with diameter ≤ 20 mm, while a dose of 20 Gy will be prescribed for metastases with diameter 21-30 mm | Radiation: Linac-based Radiosurgery with EDGE<br>* EDGE linear accelerator from Varian (Varian, Palo Alto, USA) is a C-arm machine specifically developed for radiosurgery frameless treatment. The characteristics of this linac are a high level of precision and the possibility to include multiple positioning systems for stereotactical treatments, among which Cone Beam CT (CBCT), the Optical Surface Monitoring System (OSMS), and Calypso.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic radionecrosis |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control of Brain Metastases |  | two years | 
| Disease Free survival |  | two years | 
| Overall survival |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiosurgery, brain, metastases