25-ART-HSR
"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 "
Sponsor study identifier
observational
10,000
1 country
1
Study Start
November 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 15, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 15, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2026
Actual (reported)October 26, 2026
Actual (reported)November 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 15, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 15, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Local Relapse Free Survival
Local control of the disease (at the treated site)
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
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
Up to 5 years after the treatment
Tumor lymph nodes treated with stereotactic body radiotherapy (SBRT).
Adrenal lesions treated with stereotactic body radiotherapy (SBRT).
Primary or secondary liver lesions treated with CyberKnife and tomotherapy (advanced radiotherapy).
Lung lesions treated with Stereotactic Body Radiotherapy
Lung lesions treated with stereotactic body radiotherapy (SBRT) versus moderate hypofractionated radiotherapy using advanced radiotherapy techniques.
Advanced radiotherapy techniques delivered with classic fractionation, moderate hypofractionation, ultrahypofractionation
Patients with malingant tumors or benign tumors/conditions treated with advanced radiotherapy techniques from January 2001 to May 2026
Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
Milan, Milano (MI), 20073, Italy
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.
Intensity 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.
Andrei Fodor, MD
IRCCS San Raffaele Scientific Institute
First Submitted
October 19, 2026
First Posted
October 26, 2026
Study Start
November 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 15, 2031
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
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
Up to 5 years after the treatment
Marginal Relapse Free Survival
Up to 5 years after the treatment
Regional Relapse Free Survival
Up to 5 years after the treatment
Distant Metastasis Free Survival
Up to 5 years after the treatment
Clinical Relapse Free Survival
Up to 5 years
Cancer Specific Survival
From the date of radiotherapy end until the date of death from disease progression, assessed up to 5 years
Organs Movement
Perioperative
Predictive factors
From radiotherapy end to date of local, regional progression, distant failure, death, toxicity assessed up to 5 years
Radiomic characteristics
Up to 5 years
Brain lesions treated with stereotactic radiotherapy (SRS/SRT).
Prostate cancer treated with 2 SBRT protocols (4 vs 5 fractions)
Stereotactic reirradiation of prostatic recurrences
Bone metastases treated with stereotactic body radiotherapy.
Stereotactc reirradiation of bone metastases
Paragangliomas treated with advanced radiotherapy.
Stereotactic radiotherapy for gynecological tumor metastases
Breast cancer treated with hypofractionated and ultrahypofractionated irradiation
Meningiomas treated with advanced radioherapy techniques
Pituitary adenomas treated with advanced radiotherapy techniques
Neurinomas treated with advanced radiotherapy techniques
Hemangioblastomas treated with advanced radiotherapy techniques
Arteriovenous malformations treated with radiosurgery
Trigeminal neuralgia treated with radiosurgery
Tremor treated with radiosurgery
Contact the study team to confirm eligibility.
van 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.
Gregoire 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.
Jaffray 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.
Roa 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.
Pinzi 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.
Guninski 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.
Swaminath 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.
Buchberger 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.
Franzese 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.
van 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.
Murray 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.
Palma 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.
De 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.
Myrehaug S, Sahgal A, Hayashi M, Levivier M, Ma L, Martinez R, Paddick I, Regis J, Ryu S, Slotman B, De Salles A. Reirradiation spine stereotactic body radiation therapy for spinal metastases: systematic review. J Neurosurg Spine. 2017 Oct;27(4):428-435. doi: 10.3171/2017.2.SPINE16976. Epub 2017 Jul 14.
Rulach R, Ball D, Chua KLM, Dahele M, De Ruysscher D, Franks K, Gomez D, Guckenberger M, Hanna GG, Louie AV, Moghanaki D, Palma DA, Peedell C, Salem A, Siva S, Videtic GMM, Chalmers AJ, Harrow S. An International Expert Survey on the Indications and Practice of Radical Thoracic Reirradiation for Non-Small Cell Lung Cancer. Adv Radiat Oncol. 2021 Jan 20;6(2):100653. doi: 10.1016/j.adro.2021.100653. eCollection 2021 Mar-Apr.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 15, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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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