Comparative Evaluation of Two Different Radiosurgery

Not Applicable

Completed

• Conditions: Metastases to Brain
• Interventions: Radiation: Linac-based Radiosurgery with EDGE; Radiation: Radiosurgery with Gamma Knife Perfexion

• Registration Number: NCT02355613
• Lead Sponsor: Istituto Clinico Humanitas

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 Timeline

• Study Start: 2014-12-15
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Primary Completion: 2020-06
• Study Completion: 2021-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linac-based Radiosurgery with EDGE	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
Radiosurgery with Gamma Knife Perfexion	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

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic radionecrosis	two years

Secondary Outcome Measures

Name	Time	Method
Overall survival	two years
Local Control of Brain Metastases	two years
Disease Free survival	two years

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy