At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of Glioblastoma
- ✓ECOG performance score 0-2
- ✓Surgically removable lesion per neurosurgery criteria
- ✓Healthy volunteers comparable in sex and age to patient population
- ✕Previous stroke
- ✕Another primary and/or metastatic tumor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Radioimmunotherapy in Solid Tumors (Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma)
In Brief
A clinical study evaluating Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost for Glioblastoma. Currently recruiting, targeting 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.