RecruitingNot ApplicableNCT05545007

Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

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


Sponsor

Istituto Clinico Humanitas

Enrollment

146 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches to using a focused form of radiation (radiosurgery) for people with large brain metastases who need surgery — giving radiation before the operation versus after. Researchers want to find out which approach is safer and more effective. **You may be eligible if...** - You are over 18 years old - You have a confirmed solid tumor cancer that has spread to the brain - You have 1 to 4 brain metastases, with at least one that is 2.1 cm or larger and requires surgery - You are in good physical condition (Karnofsky score of 70 or higher) - Your cancer outside the brain is controlled or responding to treatment **You may NOT be eligible if...** - You have more than 4 brain metastases - You have had whole-brain radiation before - Your cancer is small cell lung cancer, lymphoma, or a germ cell tumor - You are pregnant - You have had previous brain surgery for cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated 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.

PROCEDUREBrain metastases surgical resection

Complete surgical resection of brain lesions with adeguate margins.


Locations(9)

ASST Spedali Civili di Brescia

Brescia, Brescia, Italy

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Milan, Italy

Ospedale del Mare

Naples, Naples, Italy

Policlinico Umberto I

Rome, Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Rome, Italy

AOU Sant'Andrea

Rome, Rome, Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, Terni, Italy

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NCT05545007


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