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Clinical Trials in Italy / NCT06551909
Recruiting Not applicable

Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)

NCT06551909 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Not applicable
Started
2024-08-31
Last updated
2025-06-08

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost

Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost: Patients with Glioblastoma will receive neoadjuvant stereotactic radiotherapy to Planning Target Volume (PTV) to 30 Gy in 5 fractions, and a Simultaneous Integrated Boost delivering 35-50 GY to GTV. Patients will be divided into groups of 5 and will receive (in the absence of 2 G4 toxicities per group), the following dose levels: 35-40-42.5-45-47.5 and 50 Gy. Standard Temozolomide chemotherapy will be prescribed after surgery.

Study summary

This is a prospective multicenter study of hypofractionated radiotherapy for the radiation treatment (RT) of solid tumors and in particular for Glioblastoma (in Aim 2). It is based on the results of ongoing studies at our Institute to validate the efficacy of extremely hypofractionated RT in neoadjuvant settings, which observed immunostimulatory effects of RT and the synergy with immune components. The collaboration between San Raffaele Hospital (Milan), the IRCCS Istituto Nazionale dei Tumori Fondazione G. Pascale (Naples) and the San Giuseppe Moscati Hospital of National Relief and High Specialty (Avellino) will ensure that patient recruitment, treatment and monitoring can be translated into facilities of the National Health System using common procedures. The various departments involved will treat patients with the same methods synergistically exploring the immuno/biological factors related to efficacy (and/or toxicity), based on new radioimmunotherapeutic approaches. Clinical and research activity will be developed jointly, drawing on the expertise in radiotherapy, radiomics, oncology, imaging and immunotherapy skills already available.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Scientific Institute Milan MI Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06551909 on ClinicalTrials.gov ↗ ← All trials in Italy