Comparing preoperative and postoperative hypofractionated radiosurgery for large brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of preoperative hypofractionated stereotactic radiosurgery (HSRS) versus postoperative HSRS in patients with large brain metastases from solid tumors that are suitable for surgical resection. The study focuses on patients with a single brain metastasis measuring at least 2.1 cm and evaluates local control rates and neurological outcomes. By investigating these two approaches, the trial seeks to determine which method provides better tumor control while minimizing neurological toxicity. Participants will be randomly assigned to receive either treatment before or after their surgical procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• ASST Spedali Civili di Brescia
  Brescia, Brescia, Italy Recruiting
• AOUC Azienda Ospedaliero-Universitaria Careggi
  Florence, Florence, Italy Recruiting
• IRCCS Istituto Clinico Humanitas
  Rozzano, Milano, Italy Recruiting
• Fondazione IRCCS Istituto Neurologico Carlo Besta
  Milan, Milan, Italy Recruiting
• Ospedale del Mare
  Naples, Naples, Italy Recruiting
• Fondazione Policlinico Universitario Agostino Gemelli
  Rome, Rome, Italy Recruiting

Study contacts

• Study coordinator: Pierina Navarria, MD
• Email: pierina.navarria@cancercenter.humanitas.it
• Phone: +39 028224 7458

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tarlatamab for Small Cell Lung Cancer with Brain Metastases

  This phase II study tests whether tarlatamab can help adults with small cell lung cancer that has spread to the brain, by treating both systemic disease and brain tumors.

  Recruiting at 3 sites Phase 2 Maastricht University Medical Center · Amsterdam and 3 other locations · NCT07402343

• AI-assisted diagnosis for malignant brain tumors

  This project will test an AI system that uses routine preoperative MRI scans to automatically segment and classify malignant brain tumors in adults to help guide diagnosis and care.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang and 1 other locations · NCT07198256

• Same-day stereotactic radiation with reduced planning margins for growing or changing brain metastases

  This trial will try to see if doing MRI planning and stereotactic radiation on the same day, with either a 0 mm or 1 mm treatment margin, helps adults with growing or unstable brain metastases stay on target and reduce side effects.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT07132190

• Preventing first seizures with levetiracetam in patients with motor cortex brain metastases

  This test will try giving levetiracetam to adults with motor cortex brain metastases who have never had a seizure to see if it prevents a first seizure compared with not giving the drug.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT07130786

• Avoiding brain radiation when systemic therapy already targets brain metastases

  This pilot trial tests whether patients with brain metastases who respond to systemic therapy can skip brain radiation.

  Recruiting Phase 2 University of Vermont Medical Center · Burlington, Vermont · NCT06974370

• Using ex vivo pharmacoscopy to guide treatment for brain metastases

  This project will test whether pharmacoscopy, a lab test that screens a patient's tumor cells against many drugs, can help pick effective treatments for adults having surgery for brain metastases.

  Recruiting at 2 sites Phase 2 University of Zurich · Basel and 2 other locations · NCT06620380

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.