NCT06551909 Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)
| NCT ID | NCT06551909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-31 |
| Primary Completion | 2026-08-31 |
Trial Parameters
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Brief 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 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
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