Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551909
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Radioimmunotherapy in Solid Tumors PNRR-MCNT2-2023-12378239-Aim2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Radioimmunotherapy in Solid Tumors Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 immunobiological factors related to efficacy andor 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
Detailed Description:
This is a prospective multicenter pilot study Functional and spectroscopic neuroradiological imaging will be adopted for treatment planning Specialized software will be used to perform radiomic feature extraction and analysis of pre-trained neural networks from the advanced MRI magnetic resonance imaging and CT computed tomography used for simulation to identify distribution patterns of aggressive and radioresistant disease areas with higher probability of disease recurrence and to intensify the dose on the areas identified as more aggressive in order to counteract intrinsic radioresistance The hypofractionated radiotherapy paradigm claims the benefit of reduced treatment times improved quality of life better access to specialized treatment centers and potentially improved tumor outcomes with greater disease control and less tumor repopulation The rationale for neoadjuvant RT is based on the idea of counteracting the tumors aggressive mechanisms with radiotherapy before the disease is surgically removed in order to maximize the immunostimulatory potential of RT and therefore reduce recurrences Neoadjuvant treatment offers numerous advantages first of all the ability to adjust the dose to the pathological volume identified by MRI and limit the volume of irradiated healthy brain tissue Furthermore the use of imaging derived from functional neuroradiological and spectroscopic techniques for treatment planning would allow us to increase the dose on the areas identified as more aggressive in order act against intrinsic radioresistance One of the major risks could be the possibility of developing radionecrosis but this would not be a cause for concern in the neoadjuvant setting as all irradiated tissue will then be surgically removed Patients who agree to participate in the study and who would be candidates for radical surgical treatment according to the evaluation of the Neurosurgery Department of our Institute will be treated These patients will receive neoadjuvant radiation treatment in 5 fractions delivering 30 Gy on PTV and 35-50 Gy on GTV with a dose-escalation modality that involves increasing the dose to 35-40-425-45-475-50 Gy in groups of 5 consecutive patients using standard chemotherapy TMZ after surgery
Current diagnostic brain MRI allows a good definition of the initial disease and its most aggressive areas Since relapses have always been found to occur in irradiated areas and recent studies have shown that reducing margins does not affect overall survival smaller margins will be used from GTV to CTV and from CTV to PTV Therefore smaller volumes will be generated and treated with hypofractionation Biological equivalent doses BED to the standard prescription will be delivered with boost to a higher biological equivalent dose in the most aggressive areas in order to obtain better local control maintaining an acceptable level of toxicity and therefore improve the evolution of the disease CE marked devices software will be used according to the approved use for the definition of the target CT and MRI and for the delivery of the treatment linear accelerators and the standard drug which has the authorization for marketing will be prescribed Radiomic features related to local response and survival will be identified to obtain a predictive model At the same time we will collect PMBC and patient serum in the biobank to identify presumed immunocorrelated of therapy efficacy andor predictive biomarkers of responsetoxicity to therapy For comparative purposes serum from healthy volunteers will also be collected in numbers equivalent to patients and with sex and age characteristics comparable to the latter
Current diagnostic brain MRI allows a good definition of the initial disease and its most aggressive areas Since relapses have always been found to occur in irradiated areas and recent studies have shown that reducing margins does not affect overall survival smaller margins will be used from GTV to CTV and from CTV to PTV Therefore smaller volumes will be generated and treated with hypofractionation Biological equivalent doses BED to the standard prescription will be delivered with boost to a higher biological equivalent dose in the most aggressive areas in order to obtain better local control maintaining an acceptable level of toxicity and therefore improve the evolution of the disease CE marked devices software will be used according to the approved use for the definition of the target CT and MRI and for the delivery of the treatment linear accelerators and the standard drug which has the authorization for marketing will be prescribed Radiomic features related to local response and survival will be identified to obtain a predictive model At the same time we will collect PMBC and patient serum in the biobank to identify presumed immunocorrelated of therapy efficacy andor predictive biomarkers of responsetoxicity to therapy For comparative purposes serum from healthy volunteers will also be collected in numbers equivalent to patients and with sex and age characteristics comparable to the latter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None