Malignant Tumor25-ART-HSRNCT07894900
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
An observational study of Malignant Tumor and Benign Neoplasm, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This retrospective observational study aims to evaluate the efficacy and toxicity of advanced radiotherapy (ART) techniques, including intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and stereotactic radiotherapy (SRT), used at IRCCS Ospedale San Raffaele over the past 25 years and 5 months. Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Malignant Tumor, Benign Neoplasm, Parkinson Disease
- What is being tested?
- Advanced radiotherapy techniques
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2026to 15 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with malingant tumors or benign tumors/conditions treated with advanced radiotherapy techniques from January 2001 to May 2026
Who may be able to join
- Patients with cancer
- Patients with benign tumors/conditions
- Treated with advanced radiotherapy techniques (IMRT, IGRT, SBRT, including Gamma Knife, CyberKnife, Tomotherapy, VMAT machines)
- Treated between January 2001 and May 2026
Who cannot join
- Patients with cancer
- Treated with 2D or 3D conformational radiotherapy,
- Treated with palliative radiotherapy, not including an advanced radiotherapy technique
- Treated before January 2001 or after May 2026
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
Milan, Milano (MI), 20073
About this study
Official title: "Twenty-five Years of Advanced RadioTherapy (ART), With Intensity Modulation, Image-guidance, and Stereotactic Radiotherapy, With Classic Fractionation, Moderate- or Ultra-hypofractionation at San Raffaele Hospital "
This retrospective observational study aims to evaluate the efficacy and toxicity of advanced radiotherapy (ART) techniques, including intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and stereotactic radiotherapy (SRT), used at IRCCS Ospedale San Raffaele over the past 25 years and 5 months. The study includes treatments delivered using conventional fractionation, moderate hypofractionation, and ultra-hypofractionation. The primary endpoint is local control, defined as biochemical control in patients with prostate cancer.
Read the detailed description
25-ART-HSR is a retrospective observational study including patients treated between January 2001 and May 2026. Patients received radiotherapy according to the standard departmental protocols in place at the time of treatment and were followed for variable periods after completion of radiotherapy, in some cases for more than 10 years, depending on the anatomical site treated.
The study will include patients with a minimum follow-up of 3 months. The date of approval by the Ethics Committee will serve as the cutoff date for the final follow-up assessment.
Patient assessments were conducted in accordance with standard departmental clinical practice and included evaluations at the initial consultation, at the end of treatment, and during follow-up visits. Follow-up visits were scheduled every 3-6 months during the first 3-5 years and annually thereafter, depending on the specific pathology. Assessments included imaging examinations, such as CT, bone scintigraphy, MRI, and/or PET/CT, as appropriate to the treated site and the histology of the primary tumor, as well as laboratory tests, including tumor markers (e.g., PSA and CA 125) and pituitary hormone levels, where applicable.
At each visit, the following data were recorded: medical history, physical examination findings, toxicity assessments according to the Common Terminology Criteria for Adverse Events (CTCAE), and the occurrence 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, including tumor markers (e.g., PSA and CA 125) and pituitary hormone levels, where applicable, will be collected. Data on local, regional (lymph node), and distant disease control will also be collected from CT, MRI, and PET scans performed during follow-up. The follow-up period will range from a minimum of 3 months for recently treated patients to more than 10 years for patients treated in earlier years. Statistical, textural, and morphological radiomic features will be extracted from three-dimensional (3D) imaging datasets.
Radiotherapy is a locoregional treatment primarily aimed at achieving local disease control, a common objective across all subcohorts included in this study. Accordingly, local control will serve as the primary endpoint for the oncological cohorts and will be evaluated in comparison with historical controls, considering the potential improvements associated with advanced radiotherapy techniques that have enabled dose escalation.
For patients with prostate cancer, biochemical relapse-free survival will be the primary endpoint.
For patients treated for vascular pathologies or functional neurosurgical indications, the primary objective will be either definitive treatment success, defined as the obliteration of a vascular malformation, or improvement in neurological symptoms, such as those associated with trigeminal neuralgia, essential tremor, or Parkinson's disease.
- Conditions
- Malignant Tumor, Benign Neoplasm, Parkinson Disease, Trigeminal Neuralgia, Arteriovenous Malformations
- Being tested
- Advanced radiotherapy techniques
- Keywords
- IMRT, IGRT, SRS, SRT
- Medical subject headings
- Neoplasms, Parkinson Disease, Trigeminal Neuralgia, Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced radiotherapy techniquesRadiation
Also called IMRT, IGRT, SRS, SRT
Advanced radiotherapy techniques delivered with classic fractionation, moderate hypofractionation, ultrahypofractionation
| Study group | Role | What they receive |
|---|---|---|
| Lymph nodes | Tumor lymph nodes treated with stereotactic body radiotherapy (SBRT). Receives: Radiation: Advanced radiotherapy techniques | |
| Adrenal lesions | Adrenal lesions treated with stereotactic body radiotherapy (SBRT). Receives: Radiation: Advanced radiotherapy techniques | |
| Liver lesions | Primary or secondary liver lesions treated with CyberKnife and tomotherapy (advanced radiotherapy). Receives: Radiation: Advanced radiotherapy techniques | |
| Lung lesions | Lung lesions treated with Stereotactic Body Radiotherapy Receives: Radiation: Advanced radiotherapy techniques | |
| Lung metastasis and primary tumors | Lung lesions treated with stereotactic body radiotherapy (SBRT) versus moderate hypofractionated radiotherapy using advanced radiotherapy techniques. Receives: Radiation: Advanced radiotherapy techniques | |
| Brain lesions | Brain lesions treated with stereotactic radiotherapy (SRS/SRT). Receives: Radiation: Advanced radiotherapy techniques | |
| Prostate cancer | Prostate cancer treated with 2 SBRT protocols (4 vs 5 fractions) Receives: Radiation: Advanced radiotherapy techniques | |
| Prostate recurrences | Stereotactic reirradiation of prostatic recurrences Receives: Radiation: Advanced radiotherapy techniques | |
| Bone metastases | Bone metastases treated with stereotactic body radiotherapy. Receives: Radiation: Advanced radiotherapy techniques | |
| Bone recurrences | Stereotactc reirradiation of bone metastases Receives: Radiation: Advanced radiotherapy techniques | |
| Paragangliomas | Paragangliomas treated with advanced radiotherapy. Receives: Radiation: Advanced radiotherapy techniques | |
| Metastasis from gynecological tumors | Stereotactic radiotherapy for gynecological tumor metastases Receives: Radiation: Advanced radiotherapy techniques | |
| Breast cancer | Breast cancer treated with hypofractionated and ultrahypofractionated irradiation Receives: Radiation: Advanced radiotherapy techniques | |
| Meningiomas | Meningiomas treated with advanced radioherapy techniques Receives: Radiation: Advanced radiotherapy techniques | |
| Pituitary adenomas | Pituitary adenomas treated with advanced radiotherapy techniques Receives: Radiation: Advanced radiotherapy techniques | |
| Neurinomas | Neurinomas treated with advanced radiotherapy techniques Receives: Radiation: Advanced radiotherapy techniques | |
| Hemangioblastomas | Hemangioblastomas treated with advanced radiotherapy techniques Receives: Radiation: Advanced radiotherapy techniques | |
| Arteriovenous malformations | Arteriovenous malformations treated with radiosurgery Receives: Radiation: Advanced radiotherapy techniques | |
| Trigeminal neuralgia | Trigeminal neuralgia treated with radiosurgery Receives: Radiation: Advanced radiotherapy techniques | |
| Parkinson disease | Tremor treated with radiosurgery Receives: Radiation: Advanced radiotherapy techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Relapse Free Survival
Local control of the disease (at the treated site)
Measured: 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
Measured: 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
Measured: Up to 5 years after the treatment
Improvement of clinical symptoms
BNI (Barrow National Institute) scale for trigeminal neuralgia, a 5-point grading system, from Grade I (Excellent outcome) without pain to Grade V (Poor treatment response) with trigeminal pain with no improvement despite treatment
Measured: Up to 5 years after the treatment
Functional improvement after the treatment
TETRAS score or UPDRS for movement disorders, which includes two scales, Activities of Daily Living Scale with 12 items and a range of points from 0 to 48 and Performance scale with 9 items and a range of points from 0 to 64. Lower means less tremor on both subscales, and the two are reported separately rather than summed
Measured: Up to 5 years after the treatment
Secondary outcomes (8)
Marginal Relapse Free Survival
Marginal relapses for brain tumors
Measured: Up to 5 years after the treatment
Regional Relapse Free Survival
Relapses in regional lymph-nodes
Measured: Up to 5 years after the treatment
Distant Metastasis Free Survival
Distant recurrences
Measured: Up to 5 years after the treatment
Clinical Relapse Free Survival
Absence of local, regional and distant relapses during the follow-up
Measured: Up to 5 years
Cancer Specific Survival
Cancer Survival
Measured: 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
Measured: 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
Measured: 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
Measured: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2031 (estimated)
- Study completion15 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Fodor, MD, IRCCS San Raffaele
- Investigators
- Andrei Fodor, MD, Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894900
- Sponsor's protocol ID
- 25-ART-HSR
- Acronym
- 25-ART-HSR
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Dearnaley DP, Khoo VS, Norman AR, Meyer L, Nahum A, Tait D, Yarnold J, Horwich A. Comparison of radiation side-effects of conformal and conventional radiotherapy in prostate cancer: a randomised trial. Lancet. 1999 Jan 23;353(9149):267-72. doi: 10.1016/S0140-6736(98)05180-0.
PubMed 9929018Intensity Modulated Radiation Therapy Collaborative Working Group. Intensity-modulated radiotherapy: current status and issues of interest. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):880-914. doi: 10.1016/s0360-3016(01)01749-7.
PubMed 11704310van Herk M, Bruce A, Kroes AP, Shouman T, Touw A, Lebesque JV. Quantification of organ motion during conformal radiotherapy of the prostate by three dimensional image registration. Int J Radiat Oncol Biol Phys. 1995 Dec 1;33(5):1311-20. doi: 10.1016/0360-3016(95)00116-6.
PubMed 7493856Gregoire V, Guckenberger M, Haustermans K, Lagendijk JJW, Menard C, Potter R, Slotman BJ, Tanderup K, Thorwarth D, van Herk M, Zips D. Image guidance in radiation therapy for better cure of cancer. Mol Oncol. 2020 Jul;14(7):1470-1491. doi: 10.1002/1878-0261.12751. Epub 2020 Jun 29.
PubMed 32536001Jaffray DA, Siewerdsen JH, Wong JW, Martinez AA. Flat-panel cone-beam computed tomography for image-guided radiation therapy. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1337-49. doi: 10.1016/s0360-3016(02)02884-5.
PubMed 12128137Roa W, Kepka L, Kumar N, Sinaika V, Matiello J, Lomidze D, Hentati D, Guedes de Castro D, Dyttus-Cebulok K, Drodge S, Ghosh S, Jeremic B, Rosenblatt E, Fidarova E. International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme. J Clin Oncol. 2015 Dec 10;33(35):4145-50. doi: 10.1200/JCO.2015.62.6606. Epub 2015 Sep 21.
PubMed 26392096Pinzi V, Marchetti M, Viola A, Tramacere I, Cane I, Iezzoni C, Fariselli L. Hypofractionated Radiosurgery for Large or in Critical-Site Intracranial Meningioma: Results of a Phase 2 Prospective Study. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):153-163. doi: 10.1016/j.ijrobp.2022.08.064. Epub 2022 Sep 6.
PubMed 36075299Guninski RS, Cuccia F, Alongi F, Andratschke N, Belka C, Bellut D, Dahele M, Josipovic M, Kroese TE, Mancosu P, Minniti G, Niyazi M, Ricardi U, Munck Af Rosenschold P, Sahgal A, Tsang Y, Verbakel WFAR, Guckenberger M. Efficacy and safety of SBRT for spine metastases: A systematic review and meta-analysis for preparation of an ESTRO practice guideline. Radiother Oncol. 2024 Jan;190:109969. doi: 10.1016/j.radonc.2023.109969. Epub 2023 Nov 2.
PubMed 37922993Swaminath A, Parpia S, Wierzbicki M, Kundapur V, Faria S, Okawara GS, Tsakiridis TK, Ahmed N, Bujold A, Hirmiz K, Owen T, Leong N, Ramchandar K, Filion E, Lau H, Gabos Z, Thompson R, Yaremko B, Mehiri S, Louie AV, Quan K, Levine MN, Wright JR, Whelan TJ. Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: The LUSTRE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 Nov;10(11):1571-1575. doi: 10.1001/jamaoncol.2024.3089. Epub 2024 Sep 19.
PubMed 39298144Buchberger DS, Videtic GMM. Stereotactic Body Radiotherapy for the Management of Early-Stage Non-Small-Cell Lung Cancer: A Clinical Overview. JCO Oncol Pract. 2023 May;19(5):239-249. doi: 10.1200/OP.22.00475. Epub 2023 Feb 17. No abstract available.
PubMed 36800644Franzese C, Louie AV, Kotecha R, Zhang Z, Guckenberger M, Kim MS, Tree AC, Slotman BJ, Sahgal A, Scorsetti M. Stereotactic Body Radiation therapy for Liver Metastases: Systematic Review and Meta-Analysis With International Stereotactic Radiosurgery Society (ISRS) Practice Guidelines. Pract Radiat Oncol. 2025 Mar-Apr;15(2):e172-e188. doi: 10.1016/j.prro.2024.09.011. Epub 2024 Oct 16.
PubMed 39419281van As N, Griffin C, Tree A, Patel J, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Camilleri P, Kancherla K, Frew J, Chan A, Naismith O, Armstrong J, Staffurth J, Martin A, Dayes I, Wells P, Price D, Williamson E, Pugh J, Manning G, Brown S, Burnett S, Hall E. Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer. N Engl J Med. 2024 Oct 17;391(15):1413-1425. doi: 10.1056/NEJMoa2403365.
PubMed 39413377Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28.
PubMed 32580883Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.
PubMed 32484754De Pietro R, Zaccaro L, Marampon F, Tini P, De Felice F, Minniti G. The evolving role of reirradiation in the management of recurrent brain tumors. J Neurooncol. 2023 Sep;164(2):271-286. doi: 10.1007/s11060-023-04407-2. Epub 2023 Aug 25.
PubMed 37624529
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Twenty-five Years of Advanced RadioTherapy (ART), With Intensity Modulation, Image-guidance, and Stereotactic Radiotherapy, With Classic Fractionation, Moderate- or Ultra-hypofractionation at San Raffaele Hospital "
- ClinicalTrials.gov ID
- NCT07894900
- Acronym / sponsor ID
- 25-ART-HSR / 25-ART-HSR
- Conditions
- Malignant Tumor, Benign Neoplasm, Parkinson Disease, Trigeminal Neuralgia, Arteriovenous Malformations
- Keywords
- IMRT, IGRT, SRS, SRT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2031 (estimated)
- Study completion
- 15 Nov 2031 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational study aims to evaluate the efficacy and toxicity of advanced radiotherapy (ART) techniques, including intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and stereotactic radiotherapy (SRT), used at IRCCS Ospedale San Raffaele over the past 25 years and 5 months. The study includes treatments delivered using conventional fractionation, moderate hypofractionation, and ultra-hypofractionation. The primary endpoint is local control, defined as biochemical control in patients with prostate cancer.
Detailed description
25-ART-HSR is a retrospective observational study including patients treated between January 2001 and May 2026. Patients received radiotherapy according to the standard departmental protocols in place at the time of treatment and were followed for variable periods after completion of radiotherapy, in some cases for more than 10 years, depending on the anatomical site treated.
The study will include patients with a minimum follow-up of 3 months. The date of approval by the Ethics Committee will serve as the cutoff date for the final follow-up assessment.
Patient assessments were conducted in accordance with standard departmental clinical practice and included evaluations at the initial consultation, at the end of treatment, and during follow-up visits. Follow-up visits were scheduled every 3-6 months during the first 3-5 years and annually thereafter, depending on the specific pathology. Assessments included imaging examinations, such as CT, bone scintigraphy, MRI, and/or PET/CT, as appropriate to the treated site and the histology of the primary tumor, as well as laboratory tests, including tumor markers (e.g., PSA and CA 125) and pituitary hormone levels, where applicable.
At each visit, the following data were recorded: medical history, physical examination findings, toxicity assessments according to the Common Terminology Criteria for Adverse Events (CTCAE), and the occurrence 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, including tumor markers (e.g., PSA and CA 125) and pituitary hormone levels, where applicable, will be collected. Data on local, regional (lymph node), and distant disease control will also be collected from CT, MRI, and PET scans performed during follow-up. The follow-up period will range from a minimum of 3 months for recently treated patients to more than 10 years for patients treated in earlier years. Statistical, textural, and morphological radiomic features will be extracted from three-dimensional (3D) imaging datasets.
Radiotherapy is a locoregional treatment primarily aimed at achieving local disease control, a common objective across all subcohorts included in this study. Accordingly, local control will serve as the primary endpoint for the oncological cohorts and will be evaluated in comparison with historical controls, considering the potential improvements associated with advanced radiotherapy techniques that have enabled dose escalation.
For patients with prostate cancer, biochemical relapse-free survival will be the primary endpoint.
For patients treated for vascular pathologies or functional neurosurgical indications, the primary objective will be either definitive treatment success, defined as the obliteration of a vascular malformation, or improvement in neurological symptoms, such as those associated with trigeminal neuralgia, essential tremor, or Parkinson's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Lymph nodes | – | Radiation: Advanced radiotherapy techniquesTumor lymph nodes treated with stereotactic body radiotherapy (SBRT). |
| Adrenal lesions | – | Radiation: Advanced radiotherapy techniquesAdrenal lesions treated with stereotactic body radiotherapy (SBRT). |
| Liver lesions | – | Radiation: Advanced radiotherapy techniquesPrimary or secondary liver lesions treated with CyberKnife and tomotherapy (advanced radiotherapy). |
| Lung lesions | – | Radiation: Advanced radiotherapy techniquesLung lesions treated with Stereotactic Body Radiotherapy |
| Lung metastasis and primary tumors | – | Radiation: Advanced radiotherapy techniquesLung lesions treated with stereotactic body radiotherapy (SBRT) versus moderate hypofractionated radiotherapy using advanced radiotherapy techniques. |
| Brain lesions | – | Radiation: Advanced radiotherapy techniquesBrain lesions treated with stereotactic radiotherapy (SRS/SRT). |
| Prostate cancer | – | Radiation: Advanced radiotherapy techniquesProstate cancer treated with 2 SBRT protocols (4 vs 5 fractions) |
| Prostate recurrences | – | Radiation: Advanced radiotherapy techniquesStereotactic reirradiation of prostatic recurrences |
| Bone metastases | – | Radiation: Advanced radiotherapy techniquesBone metastases treated with stereotactic body radiotherapy. |
| Bone recurrences | – | Radiation: Advanced radiotherapy techniquesStereotactc reirradiation of bone metastases |
| Paragangliomas | – | Radiation: Advanced radiotherapy techniquesParagangliomas treated with advanced radiotherapy. |
| Metastasis from gynecological tumors | – | Radiation: Advanced radiotherapy techniquesStereotactic radiotherapy for gynecological tumor metastases |
| Breast cancer | – | Radiation: Advanced radiotherapy techniquesBreast cancer treated with hypofractionated and ultrahypofractionated irradiation |
| Meningiomas | – | Radiation: Advanced radiotherapy techniquesMeningiomas treated with advanced radioherapy techniques |
| Pituitary adenomas | – | Radiation: Advanced radiotherapy techniquesPituitary adenomas treated with advanced radiotherapy techniques |
| Neurinomas | – | Radiation: Advanced radiotherapy techniquesNeurinomas treated with advanced radiotherapy techniques |
| Hemangioblastomas | – | Radiation: Advanced radiotherapy techniquesHemangioblastomas treated with advanced radiotherapy techniques |
| Arteriovenous malformations | – | Radiation: Advanced radiotherapy techniquesArteriovenous malformations treated with radiosurgery |
| Trigeminal neuralgia | – | Radiation: Advanced radiotherapy techniquesTrigeminal neuralgia treated with radiosurgery |
| Parkinson disease | – | Radiation: Advanced radiotherapy techniquesTremor treated with radiosurgery |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with malingant tumors or benign tumors/conditions treated with advanced radiotherapy techniques from January 2001 to May 2026
Key inclusion criteria (4 listed)
- Patients with cancer
- Patients with benign tumors/conditions
- Treated with advanced radiotherapy techniques (IMRT, IGRT, SBRT, including Gamma Knife, CyberKnife, Tomotherapy, VMAT machines)
- Treated between January 2001 and May 2026
Key exclusion criteria (4 listed)
- Patients with cancer
- Treated with 2D or 3D conformational radiotherapy,
- Treated with palliative radiotherapy, not including an advanced radiotherapy technique
- Treated before January 2001 or after May 2026
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced radiotherapy techniquesAlso: IMRT, IGRT, SRS, SRTAdvanced radiotherapy techniques delivered with classic fractionation, moderate hypofractionation, ultrahypofractionation | Radiation | Adrenal lesions, Arteriovenous malformations, Bone metastases, Bone recurrences, Brain lesions, Breast cancer, Hemangioblastomas, Liver lesions, Lung lesions, Lung metastasis and primary tumors, Lymph nodes, Meningiomas, Metastasis from gynecological tumors, Neurinomas, Paragangliomas, Parkinson disease, Pituitary adenomas, Prostate cancer, Prostate recurrences, Trigeminal neuralgia |
Primary outcome
Local Relapse Free Survival
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
Local control of the disease (at the treated site)
Biochemical Relapse Free Survival
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
Biochemical control for prostate cancer
Obliteration rate
Time frame: Up to 5 years after the treatment
Obliteration rate of arteriovenous malformations
Improvement of clinical symptoms
Time frame: Up to 5 years after the treatment
BNI (Barrow National Institute) scale for trigeminal neuralgia, a 5-point grading system, from Grade I (Excellent outcome) without pain to Grade V (Poor treatment response) with trigeminal pain with no improvement despite treatment
Functional improvement after the treatment
Time frame: Up to 5 years after the treatment
TETRAS score or UPDRS for movement disorders, which includes two scales, Activities of Daily Living Scale with 12 items and a range of points from 0 to 48 and Performance scale with 9 items and a range of points from 0 to 64. Lower means less tremor on both subscales, and the two are reported separately rather than summed
8 secondary outcomes
Marginal Relapse Free Survival
Time frame: Up to 5 years after the treatment
Regional Relapse Free Survival
Time frame: Up to 5 years after the treatment
Distant Metastasis Free Survival
Time frame: Up to 5 years after the treatment
Clinical Relapse Free Survival
Time frame: Up to 5 years
Cancer Specific Survival
Time frame: From the date of radiotherapy end until the date of death from disease progression, assessed up to 5 years
Overall Survival
Time frame: From the date of radiotherapy end until the date of death from any cause, assessed up to 5 years
Acute toxicity
Time frame: Up to three months from the start of radiotherapy
Late Toxicity
Time frame: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Results publication: PubMed 9929018Dearnaley DP, Khoo VS, Norman AR, Meyer L, Nahum A, Tait D, Yarnold J, Horwich A. Comparison of radiation side-effects of conformal and conventional radiotherapy in prostate cancer: a randomised trial. Lancet. 1999 Jan 23;353(9149):267-72. doi: 10.1016/S0140-6736(98)05180-0.
- Results publication: PubMed 11704310Intensity Modulated Radiation Therapy Collaborative Working Group. Intensity-modulated radiotherapy: current status and issues of interest. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):880-914. doi: 10.1016/s0360-3016(01)01749-7.
- Results publication: PubMed 7493856van Herk M, Bruce A, Kroes AP, Shouman T, Touw A, Lebesque JV. Quantification of organ motion during conformal radiotherapy of the prostate by three dimensional image registration. Int J Radiat Oncol Biol Phys. 1995 Dec 1;33(5):1311-20. doi: 10.1016/0360-3016(95)00116-6.
- Results publication: PubMed 32536001Gregoire V, Guckenberger M, Haustermans K, Lagendijk JJW, Menard C, Potter R, Slotman BJ, Tanderup K, Thorwarth D, van Herk M, Zips D. Image guidance in radiation therapy for better cure of cancer. Mol Oncol. 2020 Jul;14(7):1470-1491. doi: 10.1002/1878-0261.12751. Epub 2020 Jun 29.
- Results publication: PubMed 12128137Jaffray DA, Siewerdsen JH, Wong JW, Martinez AA. Flat-panel cone-beam computed tomography for image-guided radiation therapy. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1337-49. doi: 10.1016/s0360-3016(02)02884-5.
- Results publication: PubMed 26392096Roa W, Kepka L, Kumar N, Sinaika V, Matiello J, Lomidze D, Hentati D, Guedes de Castro D, Dyttus-Cebulok K, Drodge S, Ghosh S, Jeremic B, Rosenblatt E, Fidarova E. International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme. J Clin Oncol. 2015 Dec 10;33(35):4145-50. doi: 10.1200/JCO.2015.62.6606. Epub 2015 Sep 21.
- Results publication: PubMed 36075299Pinzi V, Marchetti M, Viola A, Tramacere I, Cane I, Iezzoni C, Fariselli L. Hypofractionated Radiosurgery for Large or in Critical-Site Intracranial Meningioma: Results of a Phase 2 Prospective Study. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):153-163. doi: 10.1016/j.ijrobp.2022.08.064. Epub 2022 Sep 6.
- Results publication: PubMed 37922993Guninski RS, Cuccia F, Alongi F, Andratschke N, Belka C, Bellut D, Dahele M, Josipovic M, Kroese TE, Mancosu P, Minniti G, Niyazi M, Ricardi U, Munck Af Rosenschold P, Sahgal A, Tsang Y, Verbakel WFAR, Guckenberger M. Efficacy and safety of SBRT for spine metastases: A systematic review and meta-analysis for preparation of an ESTRO practice guideline. Radiother Oncol. 2024 Jan;190:109969. doi: 10.1016/j.radonc.2023.109969. Epub 2023 Nov 2.
- Results publication: PubMed 39298144Swaminath A, Parpia S, Wierzbicki M, Kundapur V, Faria S, Okawara GS, Tsakiridis TK, Ahmed N, Bujold A, Hirmiz K, Owen T, Leong N, Ramchandar K, Filion E, Lau H, Gabos Z, Thompson R, Yaremko B, Mehiri S, Louie AV, Quan K, Levine MN, Wright JR, Whelan TJ. Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: The LUSTRE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 Nov;10(11):1571-1575. doi: 10.1001/jamaoncol.2024.3089. Epub 2024 Sep 19.
- Results publication: PubMed 36800644Buchberger DS, Videtic GMM. Stereotactic Body Radiotherapy for the Management of Early-Stage Non-Small-Cell Lung Cancer: A Clinical Overview. JCO Oncol Pract. 2023 May;19(5):239-249. doi: 10.1200/OP.22.00475. Epub 2023 Feb 17. No abstract available.
- Results publication: PubMed 39419281Franzese C, Louie AV, Kotecha R, Zhang Z, Guckenberger M, Kim MS, Tree AC, Slotman BJ, Sahgal A, Scorsetti M. Stereotactic Body Radiation therapy for Liver Metastases: Systematic Review and Meta-Analysis With International Stereotactic Radiosurgery Society (ISRS) Practice Guidelines. Pract Radiat Oncol. 2025 Mar-Apr;15(2):e172-e188. doi: 10.1016/j.prro.2024.09.011. Epub 2024 Oct 16.
- Results publication: PubMed 39413377van As N, Griffin C, Tree A, Patel J, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Camilleri P, Kancherla K, Frew J, Chan A, Naismith O, Armstrong J, Staffurth J, Martin A, Dayes I, Wells P, Price D, Williamson E, Pugh J, Manning G, Brown S, Burnett S, Hall E. Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer. N Engl J Med. 2024 Oct 17;391(15):1413-1425. doi: 10.1056/NEJMoa2403365.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrei Fodor, MD principal investigator
IRCCS San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor and Benign Neoplasm, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrei Fodor, MD (+390226437634, fodor.andrei@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Relapse Free Survival (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07894900, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.