Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
Recruiting now · Not applicable
Conditions studied: Brain Metastases, Adult
In brief
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.
Key facts
- Study ID
- NCT05545007
- Run by
- Istituto Clinico Humanitas
- People needed
- 146
- Starts
- 2023-01-31
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Azienda Ospedaliera Santa Maria di Terni — Terni, Terni, Italy (enrolling)
- AOUC Azienda Ospedaliero-Universitaria Careggi — Florence, Florence, Italy (enrolling)
- IRCCS Istituto Clinico Humanitas — Rozzano, Milano, Italy (enrolling)
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Milan, Italy (enrolling)
- Ospedale del Mare — Naples, Naples, Italy (enrolling)
- ASST Spedali Civili di Brescia — Brescia, Brescia, Italy (enrolling)
- Fondazione Policlinico Universitario Agostino Gemelli — Rome, Rome, Italy (enrolling)
- AOU Sant'Andrea — Rome, Rome, Italy (enrolling)
- Policlinico Umberto I — Rome, Rome, Italy
Full record on ClinicalTrials.gov
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