An observational study in Central Nervous System Tumour, sponsored by European Institute of Oncology. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by European Institute of Oncology · Observational
Radiation therapy remains a cornerstone in the management of both benign and malignant intracranial tumors, either as monotherapy or combined with surgery and/or chemotherapy. Despite its therapeutic benefits, it is frequently associated with potential long-term adverse effects, with neurotoxicity posing a major challenge, especially in young patients affected by benign primary tumors.
In the brain, late radiotoxicities typically manifest as cognitive dysfunction, leukoencephalopathy, brain atrophy, brain tissue necrosis, cerebrovascular complications, endocrinopathies, and/or secondary malignant neoplasms.
Radiation-induced hippocampal injury, in particular, significantly contributes to cognitive impairment, while broader central nervous system effects arise through multiple mechanisms, including vascular injury, neuronal depletion, chronic inflammation, demyelination, and tissue necrosis.
The severity of cognitive dysfunction depends on multiple factors, including the location and the volume of the tumor, the total radiation dose administered, the fractionation regimen, and the individual susceptibility of the patient, as well as comorbidities (e.g., diabetes, etc.) and concomitant drugs.
The distinct physical characteristics of proton therapy, such as a reduced entrance dose, an eliminated exit dose, and a Bragg peak, provide clear dosimetric advantages over conventional photon treatments. Pencil-beam scanning further improves on earlier passive scattering approaches by delivering modulated proton beamlets for superior target conformality and reduced neutron scatter, thereby limiting low- and intermediate- dose exposure to cranial organs at risk (OARs) while preserving adequate dose coverage within the target volume.
From a radiobiological standpoint, these properties suggest that proton therapy may present a more favorable risk-benefit balance compared to photon-based modalities, particularly for long-term clinical outcomes. It achieves a drastic reduction in the integral dose, offering substantial benefit in decreasing radiation-induced second malignancies, making it mandatory for children when available.
Proton therapy is well established for treating pediatric tumors, CNS tumors such as low-grade gliomas (LGG) and meningiomas, especially if near the optic pathway or brainstem, and all the benign tumors in young patients. In these cases, the primary goal extends beyond curing the disease to preserving neurological and cognitive functions.
European Institute of Oncology is the lead sponsor of 185 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by primary central nervous system tumors and eligible for protontherapy as adjuvant or radical treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The presence of cognitive impairment
The primary endpoint will be the presence of cognitive impairment during the first 5 years after enrollment, as measured by a comprehensive neuropsychological assessment.
Time frame: From the end of Protontherapy through study completion, an average of 1 year.
Perceived cognitive impairment
For Functional Assessment of Cancer Therapy-cognition (FACT-cog) 37 items will be completed (score 1-4)
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Depressive symptoms
At Beck Depression Inventory-II (BDI-II) 21 items will be completed (score 0-3)
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Anxiety
For State-Trait Anxiety Inventory (STAI) 40 items will be completed (score 1-4)
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Quality of Life data (QoL) - EORTC QLQ C30 questionnaires.
For EORTC QLQ C30, 30 items will be completed (score 1-4).
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Sleep quality
For Pittsburgh Sleep Quality Index (PSQI) 24 items will be completed (score 0-3)
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Cognitive Reserve
For Cognitive Reserve Index questionnaire (CRIq) 20 items will be completed (core 0-1)
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Global functioning
For Montreal Cognitive Assessment (MoCA) 30 items will be completed (score 1-5).
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Learning and Verbal Memory
For Rey Auditory Verbal Learning Test (RAVLT) 15 items will be completed (score 0-4).
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Working memory
For Corsi Span backward/forward 18 items will be completed (score 0-4).
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Visual memory
For Rey-Osterrieth complex figure -recall 18 items will be completed (score 0-2).
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Visuospatial abilities
For Rey-Osterrieth complex figure -copy 18 items will be completed (score 0-2).
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Executive function
For Frontal Assessment Battery (FAB) 30 items will be completed (score 0-3).
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Attention
For Symbol digit modalities test (SDMT) 110 items will be completed (score 0-1)
Time frame: At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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