Pre-surgery ultrahypofractionated stereotactic radiotherapy with targeted dose boost for glioblastoma
Official title: Radioimmunotherapy in Solid Tumors (Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma)
Run by IRCCS San Raffaele · NCT06551909 · Data updated 2026-11-12
This trial will test whether a short course of focused pre-surgery stereotactic radiotherapy with an extra, imaging-guided dose boost helps people with operable glioblastoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | immunotherapy, radiation, chemotherapy |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | August 31, 2024 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06551909 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with a new diagnosis of glioblastoma who are medically fit (ECOG 0-2) and have a surgically removable lesion amenable to neoadjuvant stereotactic radiotherapy.
✕Probably not a fit
Patients with unresectable tumors, poor performance status (ECOG >2), prior stroke, other active primary or metastatic cancers, or who cannot undergo advanced imaging or stereotactic radiation are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective multicenter pilot study delivering neoadjuvant ultrahypofractionated stereotactic radiotherapy with a simultaneous integrated boost to biologically aggressive areas identified by advanced MRI/CT. Radiomic feature extraction and pre-trained neural networks will guide treatment planning to intensify dose on likely radioresistant tumor regions while sparing healthy brain. The protocol emphasizes short treatment time, shared procedures across participating Italian centers, and collection of clinical, radiological, and immuno-biological data. Primary aims include feasibility, safety, and early signals of improved local control and immune response.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control and reduce recurrences while shortening treatment time and limiting radiation to healthy brain.
How similar studies have gone: Early institutional and small prospective studies have reported immunostimulatory effects and feasibility for neoadjuvant or hypofractionated radiotherapy, but larger randomized evidence for this specific imaging-guided, ultrahypofractionated boost approach is still lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Glioblastoma. * ECOG performance score 0-2 (defined during the first visit) * Surgically removable lesion (according to the operability criteria established by the Neurosurgery Unit) For healthy volunteers, people who are as comparable as possible with the patient population in terms of sex and age will be recruited Exclusion Criteria: * Previous stroke * Presence of another primary and/or metastatic tumor For healthy volunteers also, absence of primary and/or metastatic tumor
Where it's running
-
IRCCS San Raffaele Scientific Institute
Milan, Mi, Italy Recruiting
Study contacts
- Principal investigator: Nadia G Di Muzio, Prof — IRCCS San Raffaele Scientific Institute
- Study coordinator: Nadia G Di Muzio, Prof
- Email: dimuzio.nadia@hsr.it
- Phone: +390226437643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.