Actively Recruiting
Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
Led by Istituto Clinico Humanitas · Updated on 2026-04-30
146
Participants Needed
9
Research Sites
204 weeks
Total Duration
On this page
Sponsors
I
Istituto Clinico Humanitas
Lead Sponsor
B
Brainlab AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Confirmed solid tumor malignancy by histology, cytology, or imaging
- Clinical recommendation for surgical removal of one brain metastasis
- Karnofsky performance status of 70 or higher
- Controlled or responding extracranial metastatic disease
- Limited brain metastases (1 to 4 lesions)
- At least one metastatic brain lesion measuring 2.1 cm or larger
- Lesions 2 cm or smaller causing mass effect, neurological symptoms, or edema not responding to steroids
- Signed informed consent form
You will not qualify if you...
- Prior whole brain radiation therapy
- Karnofsky performance status below 70
- Diagnosis of small cell lung cancer, germ cell tumor, or lymphoproliferative disease
- Pregnant women
- Previous open brain surgery for malignancy
- More than 4 brain metastases
- Inability to undergo MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
ASST Spedali Civili di Brescia
Brescia, Brescia, Italy, 25123
Actively Recruiting
2
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, Florence, Italy, 50134
Actively Recruiting
3
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
4
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Milan, Italy, 20133
Actively Recruiting
5
Ospedale del Mare
Naples, Naples, Italy, 80147
Actively Recruiting
6
Policlinico Umberto I
Rome, Rome, Italy, 00161
Active, Not Recruiting
7
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Rome, Italy, 00168
Actively Recruiting
8
AOU Sant'Andrea
Rome, Rome, Italy, 00189
Actively Recruiting
9
Azienda Ospedaliera Santa Maria di Terni
Terni, Terni, Italy, 05100
Actively Recruiting
Research Team
P
Pierina Navarria, MD
CONTACT
F
Federico Pessina, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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