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Clinical Trials in Italy / NCT05545007
Recruiting Not applicable

Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

NCT05545007 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Clinico Humanitas
Phase
Not applicable
Started
2023-01-31
Last updated
2026-04-30

Condition(s) studied

Brain Metastases, Adult

Investigational drug(s) / intervention(s)

Hypofractionated Radiosurgery (HSRS)Brain metastases surgical resection

Hypofractionated Radiosurgery (HSRS): 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 resection: Complete surgical resection of brain lesions with adeguate margins.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * Controlled or responsive extra cranial metastatic lesions * Limited brain metastases (1-4 BMs) * Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3) * Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids * Written informed consent form Exclusion Criteria: * Prior WBRT * KPS \< 70 * Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease * Pregnant women * Prior open neurosurgery for malignancy * More than 4 brain metastases * Patients with incompatibility to perform MRI

Primary outcome measure(s)

  • Rate of LMD (leptomeningeal disease) occurrence — 1 year
    Rate of LMD occurrence in patients who receive HSRS prior to surgery as compared to patients who receive HSRS after surgery. This assessment will be evaluated through radiological images.

Trial sites (9)

FacilityCityRegionStatus
ASST Spedali Civili di Brescia Brescia Brescia Recruiting
AOUC Azienda Ospedaliero-Universitaria Careggi Florence Florence Recruiting
IRCCS Istituto Clinico Humanitas Rozzano Milano Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Milan Recruiting
Ospedale del Mare Naples Naples Recruiting
Policlinico Umberto I Rome Rome Active Not Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Rome Rome Recruiting
AOU Sant'Andrea Rome Rome Recruiting
Azienda Ospedaliera Santa Maria di Terni Terni Terni Recruiting

More Istituto Clinico Humanitas trials in Italy

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Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes. Recruiting
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA Recruiting
AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART) Active, not recruiting

Other trials for the same condition

Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin Active, not recruiting
SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET) Recruiting
Glutamate Excitotoxicity in Brain Metastases From Lung, Breast and Melanoma Treated With Stereotactic Radiosurgery Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05545007 on ClinicalTrials.gov ↗ ← All trials in Italy