Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)
NCT ID: NCT06551909
Last Updated: 2025-06-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-08-31
Study Completion Date
2027-02-28
Brief Summary
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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.
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Detailed Description
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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 tumor's 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 35-40-42.5-45-47.5-50 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 and/or predictive biomarkers of response/toxicity 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 and/or predictive biomarkers of response/toxicity 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.
Conditions
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Glioblastoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is study of feasibility in terms of toxicity of a dose escalation radiotherapy procedure, with 5 patients at each dose level, on 30 patients. The dose will be increased, moving to the next 5 patients, if no more than 1 acute toxicity of grade (G) 4 will be registered.
The assumption is that the percentage of patients free from cumulative acute toxicity Gâ„3 (Common Terminology Criteria of Adverse Events-CTCAE- v5.0 scale) at 1 month after the end of treatment should not exceed 30%. A sample size of 30 patients results in a two-sided 95% confidence interval with a width of 0.328 (0.136-0.464) when the sample proportion is 0.300.
Dropouts will be replaced by patients visited later, so as to reach the expected sample. Serum from 30 healthy volunteers, with sex and age characteristics comparable to the patients, will be collected to compare the level of immune biomarkers.
The assumption is that the percentage of patients free from cumulative acute toxicity Gâ„3 (Common Terminology Criteria of Adverse Events-CTCAE- v5.0 scale) at 1 month after the end of treatment should not exceed 30%. A sample size of 30 patients results in a two-sided 95% confidence interval with a width of 0.328 (0.136-0.464) when the sample proportion is 0.300.
Dropouts will be replaced by patients visited later, so as to reach the expected sample. Serum from 30 healthy volunteers, with sex and age characteristics comparable to the patients, will be collected to compare the level of immune biomarkers.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment arm
The 30 patients will receive neoadjuvant stereotactic radiotherapy in 5 fractions delivering 30 GY to PTV and 35-50 GY with Simultaneous Integrated Boost (SIB) to GTV using standard chemotherapy (TMZ) after surgery. GTV will be treated with escalating dose levels from 35 to 50 Gy. 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
Group Type
EXPERIMENTAL
Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost
Intervention Type
RADIATION
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.
Interventions
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Neoaddjuvant 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.
Intervention Type
RADIATION
Other Intervention Names
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Ultrahypofractionated Radiotherapy
Eligibility Criteria
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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
* 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
* Presence of another primary and/or metastatic tumor For healthy volunteers also, absence of primary and/or metastatic tumor
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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European Commission
OTHER
Sponsor Role
collaborator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
NETWORK
Sponsor Role
collaborator
Azienda Ospedaliera di Rilievo Nazionale e di Alta SpecialitĂ San Giuseppe Moscati (Avellino)
UNKNOWN
Sponsor Role
collaborator
IRCCS San Raffaele
OTHER
Sponsor Role
lead
Responsible Party
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Nadia Di Muzio
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Nadia G Di Muzio, Prof
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Locations
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IRCCS San Raffaele Scientific Institute
Milan, MI, Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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PNRR-MCNT2-2023-12378239- Aim2
Identifier Type: -
Identifier Source: org_study_id
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NCT05131711
UNKNOWN
PHASE1/PHASE2
Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma
NCT01062425
COMPLETED
PHASE2
Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma
NCT01735747
UNKNOWN
PHASE2
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
NCT06616727
ENROLLING_BY_INVITATION
PHASE1
Hypofractionated Stereotactic Radiotherapy With Anlotinib in Patients With Recurrent High-Grade Gliomas
NCT04197492
ACTIVE_NOT_RECRUITING
PHASE2
Low Dose Radiation Therapy for Glioblastoma Multiforme
NCT01466686
COMPLETED
PHASE2
Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma
NCT00210314
COMPLETED
PHASE2
Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma
NCT03506139
WITHDRAWN
PHASE2
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
NCT01402063
COMPLETED
PHASE2
Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors
NCT00179803
COMPLETED
PHASE2
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
NCT02208362
ACTIVE_NOT_RECRUITING
PHASE1
Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00165477
COMPLETED
PHASE2