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Clinical Trials/NCT02355613
NCT02355613
Completed
Not Applicable

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

Istituto Clinico Humanitas1 site in 1 country250 target enrollmentStarted: December 15, 2014Last updated:
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ConditionsMetastases to Brain

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Istituto Clinico Humanitas
Enrollment
250
Locations
1
Primary Endpoint
Incidence of symptomatic radionecrosis
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts 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
  • •Diagnosis of small cell lung cancer (SCLC) or Lymphoproliferative disease
  • •Use of Avastin for at least 2 months after radiosurgery
  • •Pregnant women

Outcomes

Primary Outcomes

Incidence of symptomatic radionecrosis

Time Frame: two years

Secondary Outcomes

  • Overall survival(two years)
  • Local Control of Brain Metastases(two years)
  • Disease Free survival(two years)

Investigators

Sponsor
Istituto Clinico Humanitas
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michele Tedeschi

MD

Istituto Clinico Humanitas

Study Sites (1)

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