Comparing preoperative and postoperative hypofractionated radiosurgery for 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

This study tests whether giving targeted radiation before or after surgery helps people with large brain tumors do better and have fewer side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Clinico Humanitas (Academic / other)
• Drugs / interventions: Radiation
• Locations: 9 sites (Brescia, Brescia and 8 other locations)
• Trial ID: NCT05545007 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed solid tumor malignancy and a single brain metastasis suitable for surgical resection.

Not a fit: Patients with small cell lung cancer, prior whole brain radiation therapy, or those with a Karnofsky performance status below 70 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced neurological side effects for patients with large brain metastases.

How similar studies have performed: Recent randomized trials have shown promising results for hypofractionated stereotactic radiosurgery, suggesting that this approach may be a valid alternative to traditional methods.

Eligibility criteria

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 this trial is running

Brescia, Brescia and 8 other locations

• 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)
• Policlinico Umberto I — Rome, Rome, Italy (Active_not_recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli — Rome, Rome, Italy (Recruiting)
• AOU Sant'Andrea — Rome, Rome, Italy (Recruiting)
• Azienda Ospedaliera Santa Maria di Terni — Terni, Terni, Italy (Recruiting)

Study contacts

• Study coordinator: Pierina Navarria, MD

Conditions Brain Metastases, Adult; pre-operative hypofractionated radiosurgery; surgical resection; large brain metastases; post-operative hypofractionated radiosurgery