Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)
NCT Number: NCT06551909
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glioblastoma
Interventions: RADIATION: Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost
Sponsor: IRCCS San Raffaele
Collaborators: European Commission|Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale|Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Moscati (Avellino)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2027-02-28

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.

Primary Outcome Measures: Acute toxicity, Incidence of acute toxicity of grade 3 or 4 as maximum toxicity value during the radiation treatment or in any case within a month of the end of SBRT, using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale (toxicity from 0- patients without toxicity to 5-death from toxicity), one month
Secondary Outcome Measures: Disease Free Survival, Absence of disease progression during the follow-up, From the date of radiotherapy end until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 36 months]|Cancer Specific Survival, Death from disease progression during the follow-up, From the date of radiotherapy end until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 36 months]|Overall survival, Survival from all causes, From the date of radiotherapy end until the date of death from any cause, assessed up to 36 months|Local Relapse Free Survival, Local control of the disease (at the treated site), From the date of radiotherapy end until the date of local progression or date of death from any cause, whichever came first, assessed up to 36 months|Intracranial Relapse Free Survival, Intracranial control of the disease (glioblastoma recurrence outside the treatment field), From the date of radiotherapy end until the date of local progression or date of death from any cause, whichever came first, assessed up to 36 months|Extracranial Relapse Free Survival, Distant metastases, From the date of radiotherapy end until the date of local progression or date of death from any cause, whichever came first, assessed up to 36 months|Late toxicity, Toxicity developed after three months until the end of follow-up or death, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity, From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 36 months|Subacute Toxicity, Incidence of acute toxicity of grade 3 or 4 as maximum toxicity value registered from one to three months of the end of SBRT, using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale (toxicity from 0- patients without toxicity to 5-death from toxicity), From one up to three months after the start of radiotherapy|Incidence of Treatment-Emergent Adverse Events as assessed with brain tumor specific quality of life questionnaires, Survey with the questionnaire of European Organisation for Research and Treatment of Cancer (EORTC) Quality of life of brain tumor patients (EORTC QLQ BN20) which contains 25 questions on patients' quality of life with answers from 1, lowest grade, to 4, highest grade, 36 months|Incidence of Treatment-Emergent Adverse Events as assessed with functional-social- emotional and general well being questionnaires, Survey with the questionnaire FACT-Br on patients' quality of life with answers from 0, lowest grade, to 4, highest grade, 36 months|Incidence of Treatment-Emergent Adverse Events as assessed with mental status questionnaires, Survey with the questionnaire Mini Mental Status Examination (MMSE). A score of 24-30 indicates normal abilities, while a lower score indicates cognitive deficit., 36 months|Periferic mononuclear blood cells (PMBC) subtypes predictive for disease progression and death, Identification of immune prognostic factors, studying lymphocyte subpopulations and their impact on the results obtained., Form the start of radiotherapy up to 6 months
Other Outcome Measures: Radiomics, Evaluation of radiomic characteristics: Mathematical extraction of the spatial distribution of signal intensities and pixel interrelationships of medical images of the patients, to quantify textural information resampled according to International Biomarker Standardization Initiative (IBSI)., 36 months|Predictive factors for disease progression and death, To identify potential risk factors, the association of clinical and radiation treatment factors with survival outcomes will be estimated using survival trees, univariate/multivariate Cox regression models, From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 36 months