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Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

RecruitingNAAges 18 Years - anyAllIstituto Clinico Humanitas
NCT05545007 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Hypofractionated Radiosurgery (HSRS)
  • Brain metastases surgical resection
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Where

9 sites
ASST Spedali Civili di Brescia
Brescia, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Ospedale del Mare
Naples, Italy
Policlinico Umberto I
Rome, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy
AOU Sant'Andrea
Rome, Italy

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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