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Completed

NCT Number: NCT02355613

Comparative Evaluation of Two Different Radiosurgery

Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients

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Key information

Conditions

Metastases to Brain Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiosurgery with Gamma Knife Perfexion

Radiation

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

Radiation

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 outcomes

  1. Incidence of symptomatic radionecrosis

    Time frame: two years

Secondary outcomes

  1. Local Control of Brain Metastases

    Time frame: two years

  2. Disease Free survival

    Time frame: two years

  3. Overall survival

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Feb 4, 2015
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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