CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 146 target
Drug / intervention
Hypofractionated Radiosurgery (HSRS) +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 7
  • Age greater than 18 years
  • Histological, cytological, or radiological confirmation of solid tumor malignancy
  • Clinical indication for surgical resection of one brain metastasis
  • Controlled or responsive extracranial metastatic lesions
Key exclusion· 6
  • Prior whole brain radiotherapy (WBRT)
  • Diagnosis of small cell lung cancer, germinal cell tumor, or lymphoproliferative disease
  • Pregnant women
  • Prior open neurosurgery for malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05545007
NCT05545007N/ARecruitingHigh MomentumUpdated 2mo ago
Long Recruiting

Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection

Istituto Clinico Humanitas·interventional·Posted Sep 19, 2022·Updated Apr 30, 2026

In Brief

A clinical study evaluating Hypofractionated Radiosurgery (HSRS) and Brain metastases surgical resection for Brain Metastases, Adult. Currently recruiting, targeting 146 participants across 9 sites.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsBrainlab AG

Timeline

N/ARecruiting
20232024202520262027
First PostedSep 19, 2022
Enrollment StartJan 31, 2023
Primary CompletionJan 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 3.8 years agoPrimary completion in 6 months

Interventions

Hypofractionated Radiosurgery (HSRS)radiation

HSRS converges multiple radiation beams to deliver a single, large dose of radiation to a discrete tumor target with high precision, thereby minimizing radiation dose to the surrounding normal tissue.

Brain metastases surgical resectionprocedure

Complete surgical resection of brain lesions with adeguate margins.