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

Study Overview

• Status: Completed
• Conditions: Metastases to Brain
• Intervention / Treatment: Radiation: Radiosurgery with Gamma Knife Perfexion; Radiation: Linac-based Radiosurgery with EDGE

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiosurgery with Gamma Knife Perfexion; 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; 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.
Active Comparator: Linac-based Radiosurgery with EDGE; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of symptomatic radionecrosis	two years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Marta Scorsetti, MD, Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2014
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Radiosurgery, brain, metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 1268