Comparative Evaluation of Two Different Radiosurgery

Istituto Clinico Humanitas

Status: Completed

Conditions: Metastases to Brain

Treatments: Radiation: Linac-based Radiosurgery with EDGE; Radiation: Radiosurgery with Gamma Knife Perfexion

Study type: Interventional

Funder types: Other

Identifiers

NCT02355613

1268

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Radiosurgery with Gamma Knife Perfexion

Active Comparator group

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

Treatment:

Radiation: Radiosurgery with Gamma Knife Perfexion

Linac-based Radiosurgery with EDGE

Active Comparator group

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

Treatment:

Radiation: Linac-based Radiosurgery with EDGE