Comparative Evaluation of Two Different Radiosurgery

Metastases to Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355613
• Other study ID #: 1268
• Status: Completed
• Phase: N/A
• Start date: December 15, 2014
• Est. completion date: July 2021

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastases to Brain
• Neoplasm Metastasis

Intervention

Radiation:
• Radiosurgery 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.
• Linac-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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of symptomatic radionecrosis		two years
Secondary	Local Control of Brain Metastases		two years
Secondary	Disease Free survival		two years
Secondary	Overall survival		two years