NCT02355613

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

5.5 years

First QC Date

January 13, 2015

Last Update Submit

May 3, 2022

Conditions

Metastases to Brain

Keywords

Radiosurgery, brain, metastases

Outcome Measures

Primary Outcomes (1)

  • Incidence of symptomatic radionecrosis

    two years

Secondary Outcomes (3)

  • Local Control of Brain Metastases

    two years

  • Disease Free survival

    two years

  • Overall survival

    two years

Study Arms (2)

Radiosurgery with Gamma Knife Perfexion

ACTIVE COMPARATOR

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

Linac-based Radiosurgery with EDGE

ACTIVE COMPARATOR

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

Interventions

Radiosurgery with Gamma Knife PerfexionRADIATION

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.

Radiosurgery with Gamma Knife Perfexion
Linac-based Radiosurgery with EDGERADIATION

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.

Linac-based Radiosurgery with EDGE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 85 years
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

Location

Related Publications (1)

  • Scorsetti M, Navarria P, Cozzi L, Clerici E, Bellu L, Franceschini D, Marzo AM, Franzese C, Torri V, Reggiori G, Lobefalo F, Raspagliesi L, Attuati L, Pessina F, Franzini A, Picozzi P, Tomatis S. Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform. Radiat Oncol. 2023 Feb 7;18(1):28. doi: 10.1186/s13014-023-02216-5.

    PMID: 36750848DERIVED

MeSH Terms

Conditions

Brain NeoplasmsNeoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marta Scorsetti, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 4, 2015

Study Start

December 15, 2014

Primary Completion

June 1, 2020

Study Completion

July 1, 2021

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

IT(1)