Health Trials

Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

ConditionBrain Metastases, Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.

Eligibility criteria

Qualifiers

Age >18 years

Histological or cytological or radiological confirmation of solid tumor malignancy

Clinical indication for surgical resection of one brain metastasis

Karnosky performance status (KPS) ≥70

Disqualifiers

Prior WBRT

KPS < 70

Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease

Pregnant women

Trial design

Treatments tested in this trial

  • Hypofractionated Radiosurgery (HSRS)
  • Brain metastases surgical resection

Treatment groups

146 Participants
are divided into 2 treatment groups

Locations

9
ASST Spedali Civili di Brescia25123, BresciaBrescia, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi50134, FlorenceFlorence, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta20133, MilanMilan, Italy
IRCCS Istituto Clinico Humanitas20089, RozzanoMilano, Italy

Sponsors and collaborators

Istituto Clinico Humanitas

Lead sponsor

Brainlab AG

Collaborator

Source ClinicalTrials.gov