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Comparative Evaluation of Two Different Radiosurgery

Primary Purpose

Metastases to Brain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radiosurgery with Gamma Knife Perfexion
Linac-based Radiosurgery with EDGE
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastases to Brain focused on measuring Radiosurgery, brain, metastases

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Clinico Humanitas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Radiosurgery with Gamma Knife Perfexion

Linac-based Radiosurgery with EDGE

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of symptomatic radionecrosis

Secondary Outcome Measures

Local Control of Brain Metastases
Disease Free survival
Overall survival

Full Information

First Posted
January 13, 2015
Last Updated
May 3, 2022
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02355613
Brief Title
Comparative Evaluation of Two Different Radiosurgery
Official Title
Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2014 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastases to Brain
Keywords
Radiosurgery, brain, metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiosurgery with Gamma Knife Perfexion
Arm Type
Active Comparator
Arm Description
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
Arm Title
Linac-based Radiosurgery with EDGE
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery with Gamma Knife Perfexion
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Linac-based Radiosurgery with EDGE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of symptomatic radionecrosis
Time Frame
two years
Secondary Outcome Measure Information:
Title
Local Control of Brain Metastases
Time Frame
two years
Title
Disease Free survival
Time Frame
two years
Title
Overall survival
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Scorsetti, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Comparative Evaluation of Two Different Radiosurgery

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