RecruitingNot ApplicableNCT06551909

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

Radioimmunotherapy in Solid Tumors (Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma)

Sponsor

IRCCS San Raffaele

Enrollment

30 participants

Start Date

Aug 31, 2024

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria2

Previous stroke
Presence of another primary and/or metastatic tumor For healthy volunteers also, absence of primary and/or metastatic tumor

Interventions

RADIATIONNeoaddjuvant 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.