An observational study in Malignant Tumor, Benign Neoplasm and Parkinson Disease, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 6 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by IRCCS San Raffaele · Observational
This retrospective observational study aims to evaluate the efficacy and toxicity of advanced radiotherapy (ART) techniques- intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and stereotactic radiotherapy (SRT)-employed over the past 25 years and 5 months at the IRCCS Ospedale San Raffaele, using conventional fractionation, moderate hypofractionation, and ultra-hypofractionation. The primary objective is local control (biochemical control for prostate cancer).
25-ART-HSR is a retrospective observational study including patients treated between January 2001 and May 2026. Patients were irradiated according to the department's standard protocols in place at the time of treatment and were followed for a variable period after the completion of radiotherapy-in some cases for more than 10 years, depending on the site treated. The study will evaluate patients with a minimum follow-up period of 3 months, with the date of ethics committee approval serving as the cutoff for the final recorded follow-up. Patient assessment followed standard departmental clinical practice: evaluations were conducted at the initial consultation, at the end of treatment, and during follow-up visits-scheduled every 3-6 months for the first 3-5 years, and annually thereafter-depending on the specific pathology. These assessments included CT scans, bone scans, MRI, and/or PET/CT (as dictated by the treated sites and the histology of the primary tumor), as well as laboratory tests, including tumor markers (e.g., PSA, CA 125, pituitary hormones, etc.). At each visit, the following data were recorded: medical history, physical examination, toxicity assessment (based on CTCAE-Common Terminology Criteria for Adverse Events) criteria, and any instances of local or regional (lymph node) recurrence, skeletal-related events, visceral metastases, subsequent courses of radiotherapy, additional lines of systemic therapy, or palliative treatments. Data on biochemical monitoring (tumor markers such as PSA, CA 125, pituitary hormones, etc.) will be collected, as well as data on local, regional (lymph node), or distant disease control, derived from CT, MRI, and PET scans performed by the patient throughout the follow-up period (ranging from a minimum of 3 months for recently treated patients to over 10 years for those treated in the past). Statistical, textural, and morphological radiomic features will be extracted from 3D images. Radiotherapy is a loco-regional treatment primarily aimed at local disease control-a common factor across all the sub-cohorts to be analyzed. Consequently, local control-achieved through advanced techniques that have enabled an increase in treatment dosage-will serve as the primary endpoint, evaluated against historical controls. For prostate cancer biochemical relapse free survival is the primary end-point. In the context of vascular pathology or functional neurosurgery, the primary objective is either a cure (i.e., the occlusion of a vascular malformation) or the improvement of neurological symptoms (such as trigeminal neuralgia, essential tremor, or Parkinson's disease).
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →IRCCS San Raffaele is the lead sponsor of 451 studies on the registry; 235 are open to participants now.
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Patients with malingant tumors or benign tumors/conditions treated with advanced radiotherapy techniques from January 2001 to May 2026
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.
Patients treated with advanced radiotherapy techniques (IMRT, IGRT, SBRT) with Gamma Knife, CyberKnife, Tomotherapy, VMAT
Exclusion Criteria:
Patients treated with 2D or 3D conformational radiotherapy, and those treated with palliative radiotherapy, not including an advanced radiotherapy technique will be excluded.
Tumor lymph nodes treated with stereotactic body radiotherapy (SBRT).
Radiation: Advanced radiotherapy techniques
Adrenal lesions treated with stereotactic body radiotherapy (SBRT).
Radiation: Advanced radiotherapy techniques
Primary or secondary liver lesions treated with CyberKnife and tomotherapy (advanced radiotherapy).
Radiation: Advanced radiotherapy techniques
Lung lesions treated with Stereotactic Body Radiotherapy
Radiation: Advanced radiotherapy techniques
Lung lesions treated with SBRT vs moderate hypofractionation delivered with advanced radiotherapy.
Radiation: Advanced radiotherapy techniques
Brain lesions treated with stereotactic radiotherapy (SRS/SRT).
Radiation: Advanced radiotherapy techniques
Prostate cancer treated with 2 SBRT protocols (4 vs 5 fractions)
Radiation: Advanced radiotherapy techniques
Stereotactic reirradiation of prostatic recurrences
Radiation: Advanced radiotherapy techniques
Bone metastases treated with stereotactic body radiotherapy.
Radiation: Advanced radiotherapy techniques
Stereotactc reirradiation of bone metastases
Radiation: Advanced radiotherapy techniques
Paragangliomas treated with advanced radiotherapy.
Radiation: Advanced radiotherapy techniques
Stereotactic radiotherapy for gynecological tumors metastasis
Radiation: Advanced radiotherapy techniques
Breast cancer hypofractionated and ultr-hypofractionated irradiation
Radiation: Advanced radiotherapy techniques
Meningiomas treated with advanced radioherapy techniques
Radiation: Advanced radiotherapy techniques
Pituitary adenomas treated with advanced radiotherapy techniques
Radiation: Advanced radiotherapy techniques
Neurinomas treated with advanced radiotherapy techniques
Radiation: Advanced radiotherapy techniques
Hemangioblastomas treated with advanced radiotherapy techniques
Radiation: Advanced radiotherapy techniques
Arteriovenous malformations treate with radiosurgery
Radiation: Advanced radiotherapy techniques
Trigeminal neuralgia treated with radiosurgery
Radiation: Advanced radiotherapy techniques
Tremor treated with radiosurgery
Radiation: Advanced radiotherapy techniques
Advanced radiotherapy techniques delivered with classic fractionation, moderate hypofractionation, ultrahypofractionation
Also known as: IMRT, IGRT, SRS, SRT
Local Relapse Free Survival
Local control of the disease (at the treated site)
Time frame: 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 5 years
Biochemical Relapse Free Survival
Biochemical control for prostate cancer
Time frame: From the date of radiotherapy end until the date of biochemical progression or date of death from any cause, whichever came first, assessed up to 5 years
Obliteration rate
Obliteration rate of arteriovenous malformations
Time frame: Up to 5 years after the treatment
Improvement of clinical symptoms
BNI (Barrow National Institute) scale for trigeminal neuralgia.
Time frame: Up to 5 years after the treatment
Functional improvement after the treatment
TETRAS score or UPDRS for movement disorders
Time frame: Up to 5 years after the treatment
Marginal Relapse Free Survival
Marginal relapses for brain tumors
Time frame: Up to 5 years after the treatment
Regional Relapse Free Survival
Relapses in regional lymph-nodes
Time frame: Up to 5 years after the treatment
Distant Metastasis Free Survival
Distant recurrences
Time frame: Up to 5 years after the treatment
Clinical Relapse Free Survival
Absence of local, regional and distant relapses during the follow-up
Time frame: Up to 5 years
Cancer Specific Survival
Cancer Survival
Time frame: From the date of radiotherapy end until the date of death from disease progression, assessed up to 5 years
Overall Survival
Survival from all causes
Time frame: From the date of radiotherapy end until the date of death from any cause, assessed up to 5 years
Acute toxicity
Toxicity developed in the first three months after the treatment, 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
Time frame: Up to three months from the start of radiotherapy
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
Time frame: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
Organs Movement
Modeling of organ movements during treatment.
Time frame: Perioperative
Predictive factors
actors predicting survival. Survival trees, univariate/multivariate Cox regression models will be estimated to identify potential risk factors associated with survival and toxicity outcomes
Time frame: From radiotherapy end to date of local, regional progression, distant failure, death, toxicity assessed up to 5 years
Radiomic characteristics
Evaluation of radiomic features on CT images in relation to clinical and histological parameters and their predictive role for treatment response
Time frame: Up to 5 years
Plan to share: Yes — The data that support the findings of this study (anonymized individual participant data) are available on request from the corresponding author to researchers who provide a methodologically sound proposal. Requests made to the principal investigator (AF) will be evaluated by the Lombardy Territorial Ethics Committee 1
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: for another 2 years after the closure of the study
Access criteria: Request from the principal investigator approved by the Lombardy Territorial Ethics Committee 1
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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