Metastases to Brain
Conditions
Keywords
Radiosurgery, brain, metastases
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.
Interventions
RADIATIONRadiosurgery with Gamma Knife Perfexion
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.
RADIATIONLinac-based Radiosurgery with EDGE
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.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic radionecrosis | two years |
Secondary
| Measure | Time frame |
|---|---|
| Local Control of Brain Metastases | two years |
| Disease Free survival | two years |
| Overall survival | two years |
Countries
Italy
Outcome results
None listed