Renal CancerSBRTRCNCT07285538
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
A study testing Stereotactic body radiotherapy (SBRT) in people with Renal Cancer and Renal Secondary Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (standard prescriptions for the internationl guidelines, according to tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Renal Secondary Cancer, Stereotactic Body Radiotherapy
- What is being tested?
- Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 14 Sep 2026to 15 Jan 2033
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or clinical diagnosis of primary or secondary kidney tumors
- Patients aged ≥18 years
- Signed informed consent
- Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions)
- PS (ECOG) ≤2
- No prior local radiotherapy
- Fertile women using contraception methods previously initiated (a pregnancy test will be prescribed)
Who cannot join
- Patients aged < 18 years
- Tumors > 10 cm
- PS ECOG ≥3
- Psychiatric or other disorders that may prevent the patient from signing informed consent
- Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)
- Pregnant women
- Collagen diseases
- Sjogren's syndrome
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, 1 recruiting
- Recruiting
Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
Milan, Milano (MI), 20073
Andrei Fodor, MD, +390226437643, fodor.andrei@hsr.it
Nadia Di Muzio, Prof., +390226437643, dimuzio.nadia@hsr.it
About this study
Official title: A Prospective Interventional Study of Stereotactic Body RadioTherapy (SBRT) With Continuous Tracking for Inoperable Patients With Primary and Secondary Renal Cancer (SBRTRC)
This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (standard prescriptions for the internationl guidelines, according to tumor size), using a robotic accelerator -CyberKnife® (Accuray, Sunnyvale, CA)-, with fiducial-tracking, to observe the acute and late toxicity reduction (as primary objectives), due to the maximum precision of the treatment. Secondary objectives are Local Relpase-Free Survival (LRFS), Regional Relapse-Free Survival (RRFS), Distant Metastasis-Free Survival (DMFS), Disease-Free Survival (DFS), Cancer Specific Survival (CSS), Overall Survival (OS) and Quality-of-Life (QoL). A total of 60 participants are expected to be enrolled over four years, and the follow-up of enrolled patients will be three years.
Read the detailed description
Renal Cell Carcinoma (RCC) is the eighth most common cancer diagnosed in Europe, with a rising incidence, particularly in old patients. The standard of care for operable patients with primary RCC is surgical resection, however, not all patients are suitable candidates for surgery. Alternative approaches, such as thermal ablation, present significant limitations, as reduced efficacy for lager tumors (>3-4 cm) and those located near the renal hilum.
Traditionally, Radiotherapy (RT) has not been considered an effective treatment for RCC due to its perceived radioresistance. High dose radiation therapy RCC leads to both direct cancer cell death and indirect cancer death from vasculature disruption.
The paradigm of radioresistance has shifted significantly with the advent of stereotactic body radiotherapy/ ablative radiotherapy (SBRT/SABR), which has demonstrated promising efficacy in local control while preserving renal function. The radiosensitivity varies in laboratory studies, with low α/β values (2.6 Gy - 6.9 Gy), thus RCC's lines are more responsive to increased radiation fraction size.
SBRT is non-invasive, delivers high doses with precision, using a steep dose gradient over a small number of treatment sessions. This approach has recently demonstrated promising local control (LC), and acceptable toxicity, even for large tumors.
IROCK (the International Radiosurgery Consortium of the Kidney) included 223 patients pooled from nine institutions, with a median follow up of 30 months. No difference in LC and toxicity was observed between patients receiving single fraction SBRT at 25 Gy (range 14-26 Gy) and multiple fractions SBRT at a median of 40 Gy (range 24-70 Gy) in four fractions was observed.
In 2022, IROCK reported the 5-year outcomes of 190 patients with primary RCC. The 7-year cumulative local failure rate was 8.4%, with no significant difference in the incidence of grade ≥2 between single fraction SBRT (5%) and multi-fraction SBRT (6%).
The TransTasman Radiation Oncology Group (TROG) 15.03 FASTRACK II trial was a non-randomized, phase 2, multicenter study with 71 pts enrolled, and 70 underwent SBRT. Treatment was delivered according to tumor size, with 23 patients (33%) received a single- fraction dose of 26 Gy (for tumors ≤ 4 cm) and 47 patients received 42 Gy in 3 fractions (for tumors >4 and ≤10 cm). Median follow up was 43 months. Local Control was 100%, with no observed local failures during the study protocol. Cancer specific survival was 100%, while freedom from distant failure was 97% at 36 months. Overall Survival was 82% at 36 months. SBRT was well tolerated with no grade 4 or 5 adverse events. The systematic review conducted for the International Society of Stereotactic Radiosurgery (ISRS) guidelines analyzed 36 studies with 822 patients. The median LC was 94.1 % (range 70-100%), 5-year progression-free survival was 80.5 % (range 72-92%), and 5- year Overall Survival was 77.2 %. SBRT was associated with minimal impact on renal function, with only a 3.9% of patients requiring post treatment dialysis across studies. Abancourt et al. analyzed 144 patients treated between 2008 and 2020, mainly with 26 Gy/ 1 fraction and 42 Gy/ 3 fractions, and with a 43 month median follow-up (IQR 24-81.2) local control at 5 years was 96%. Overall survival was 58 months and 5-year cumulative incidence of cancer related deaths was 8% (95% CI 3-15%). As much as 49% of patients experienced at least one toxicity, of which 32% were grade 1, 14% grade 2 and 1% grade 3. Two patients (1%) underwent dialysis. Median eGFR loss was 7 ml/min (IQR -17; 0) at the last follow-up.
The proposed clinical study involves a cutting-edge dose delivery method and a precise treatment planning. The high-dose conformation and real-time imaging accuracy for target identification and adjustment during treatment ensure the validity of this approach.
The treatment will be performed according to current guidelines. For primary disease definitive radiation therapy using SBRT will be considered as a treatment option for non-optimal surgical candidates, for patients with T1 tumors (<10 cm in diameter, according to FASTRACK II trial). SBRT will be delivered using 1-5 fractions. Dose and fractionation options will attempt to keep the biologically effective dose (BED) to ≥80 Gy assuming an α/β ratio of 10 due to association with improved local control.
This is a prospective, interventional, monocentric, clinical study of SBRT for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 40-50 Gy/5 fractions (according to tumor size), using CyberKnife with fiducial-tracking. The primary objective is acute and late toxicity reduction, due to the maximum precision of the treatment. Secondary objectives concern loco-regional and distant control, overall and specific survival, quality-of-life.
The study plans to enroll a total of 60 patients, needed for the ≥ G2 toxicity analysis , according to the study design, and with 20% compensation for potential drop-outs.
- Being tested
- Stereotactic body radiotherapy (SBRT)
- Keywords
- Renal primary tumors, Renal secondary tumors, stereotactic body radiotherapy, stereotactic ablative radiotherapy, Renal toxicity
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT)Radiation
SBRT for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (according to tumor size), using CyberKnife
| Study group | Role | What they receive |
|---|---|---|
| Prospective, interventional, monocentric, clinical study of SBRT for primary/secondary renal tumor | Experimental | SBRT to renal lesions will be delivered using 1-5 fractions. Dose and fractionation options will attempt to keep the biologically effective dose (BED) to ≥80 Gy assuming an α/β ratio of 10 due to association with improved local control. Established dosing regimens include:
* 25-26 Gy in 1 fraction, for lesion in the greatest diameter (or sum of diameters in case of multiple lesions) up to 4 cm of maximum diameter
* 42-48 Gy in 3-4 fractions, for lesion in the greatest diameter (or sum of diameters in case of multiple lesions) up to 6 cm of maximum diameter
* 40-50 Gy in 5 fractions, for lesion larger than 6 cm in the greatest diameter (or sum of diameters in case of multiple lesions) For multi-fraction dosing, treatment will be delivered on consecutive or alternate days. Receives: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Acute toxicity grade ≥2 as the maximum toxicity value at 3 months after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
Measured: 3 months
Late toxicity
Late toxicity grade ≥2 as the maximum toxicity value at 3 years after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
Measured: 3 years
Secondary outcomes (7)
Local control of the treated lesion (LC)
Local control of the treated site expressed in terms of local recurrence rate
Measured: 3 years
Local Relapse-Free Survival (time to local recurrence, LRFS)
From the date of radiotherapy end until the date of local relapse, assessed up to 3 years
Measured: 3 years
Regional Relapse-Free Survival (RRFS)
From the date of radiotherapy end until the date of regional relapse, assessed up to 3 years
Measured: 3 years
Distant Metastases-Free Survival (DMFS)
From the date of radiotherapy end until the date of distant metasis diagnosis, assessed up to 3 years
Measured: 3 years
Disease-Free Survival (local, regional, distant, DFS)
From the date of radiotherapy end until the date of first, any ( local, regional, distant) relapse, assessed up to 3 years
Measured: 3 years
Cancer Specific Survival (CSS)
From the date of radiotherapy end until the date of death from renal cancer, assessed up to 3 years
Measured: 3 years
Overall Survival (OS)
From the date of radiotherapy end until the date of death from any cause, assessed up to 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start14 Sep 2026
- Primary completion15 Jan 2033 (estimated)
- Study completion15 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A total of 60 patients are expected to be enrolled in this prospective, non-randomized study. For the sample size calculation, a power of 80% and a significance level (α) of 5% are set. The hypothesis is that the proportion of patients free from ≥G2 toxicity 3 years after the end of treatment is less than or equal to 13% which is inferior to the ≥G2 toxicity of 36% registered in the FASTRACK II trial. Considering a simple proportion study a total of 60 patients are required, including an additional 20% to compensate for potential drop-outs (relative to toxicity outcome). In case of reaching toxicity and local control objectives the study will be closed after another two years of follow-up.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Di Muzio, IRCCS San Raffaele
- Investigators
- Nadia G Di Muzio, Prof., Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285538
- Sponsor's protocol ID
- SBRTRC
- Acronym
- SBRTRC
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abancourt L, Ali M, Quivrin M, Wallet J, Schick U, Ingrosso G, Supiot S, Franzese C, Scorsetti M, Kerkmeijer L, Fodor A, Muzio ND, Jousset N, Boisserie T, Detti B, Nicosia L, Alongi F, Trippa F, Leleu T, Dessoude L, Terlizzi M, Blanchard P, Scher N, Toledano A, Baude J, Lartigau E, Barthoulot M, Siva S, Pasquier D. Results of Stereotactic Body Radiation Therapy for Primary Renal Cell Carcinoma in a Large Multicenter Series. Eur Urol Oncol. 2025 Jun;8(3):774-781. doi: 10.1016/j.euo.2025.01.001. Epub 2025 Feb 7.
PubMed 39920013Siva S, Bressel M, Sidhom M, Sridharan S, Vanneste BGL, Davey R, Montgomery R, Ruben J, Foroudi F, Higgs B, Lin C, Raman A, Hardcastle N, Hofman MS, De Abreu Lourenco R, Shaw M, Mancuso P, Moon D, Wong LM, Lawrentschuk N, Wood S, Brook NR, Kron T, Martin J, Pryor D; FASTRACK II Investigator Group. Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial. Lancet Oncol. 2024 Mar;25(3):308-316. doi: 10.1016/S1470-2045(24)00020-2.
PubMed 38423047Siva S, Ali M, Correa RJM, Muacevic A, Ponsky L, Ellis RJ, Lo SS, Onishi H, Swaminath A, McLaughlin M, Morgan SC, Cury FL, Teh BS, Mahadevan A, Kaplan ID, Chu W, Grubb W, Hannan R, Staehler M, Warner A, Louie AV. 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis from IROCK (the International Radiosurgery Consortium of the Kidney). Lancet Oncol. 2022 Dec;23(12):1508-1516. doi: 10.1016/S1470-2045(22)00656-8. Epub 2022 Nov 16.
PubMed 36400098Siva S, Louie AV, Warner A, Muacevic A, Gandhidasan S, Ponsky L, Ellis R, Kaplan I, Mahadevan A, Chu W, Swaminath A, Onishi H, Teh B, Correa RJ, Lo SS, Staehler M. Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK). Cancer. 2018 Mar 1;124(5):934-942. doi: 10.1002/cncr.31156. Epub 2017 Dec 20.
PubMed 29266183Ali M, Mooi J, Lawrentschuk N, McKay RR, Hannan R, Lo SS, Hall WA, Siva S. The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. Eur Urol. 2022 Dec;82(6):613-622. doi: 10.1016/j.eururo.2022.06.017. Epub 2022 Jul 14.
PubMed 35843777Siva S, Chesson B, Bressel M, Pryor D, Higgs B, Reynolds HM, Hardcastle N, Montgomery R, Vanneste B, Khoo V, Ruben J, Lau E, Hofman MS, De Abreu Lourenco R, Sridharan S, Brook NR, Martin J, Lawrentschuk N, Kron T, Foroudi F. TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II. BMC Cancer. 2018 Oct 23;18(1):1030. doi: 10.1186/s12885-018-4916-2.
PubMed 30352550Rich BJ, Noy MA, Dal Pra A. Stereotactic Body Radiotherapy for Localized Kidney Cancer. Curr Urol Rep. 2022 Dec;23(12):371-381. doi: 10.1007/s11934-022-01125-6. Epub 2022 Nov 16.
PubMed 36383304Moreno-Olmedo E, Sabharwal A, Das P, Dallas N, Ford D, Perna C, Camilleri P. The Landscape of Stereotactic Ablative Radiotherapy (SABR) for Renal Cell Cancer (RCC). Cancers (Basel). 2024 Jul 27;16(15):2678. doi: 10.3390/cancers16152678.
PubMed 39123406Siva S, Louie AV, Kotecha R, Barber MN, Ali M, Zhang Z, Guckenberger M, Kim MS, Scorsetti M, Tree AC, Slotman BJ, Sahgal A, Lo SS. Stereotactic body radiotherapy for primary renal cell carcinoma: a systematic review and practice guideline from the International Society of Stereotactic Radiosurgery (ISRS). Lancet Oncol. 2024 Jan;25(1):e18-e28. doi: 10.1016/S1470-2045(23)00513-2.
PubMed 38181809Palumbo C, Pecoraro A, Knipper S, Rosiello G, Luzzago S, Deuker M, Tian Z, Shariat SF, Simeone C, Briganti A, Saad F, Berruti A, Antonelli A, Karakiewicz PI. Contemporary Age-adjusted Incidence and Mortality Rates of Renal Cell Carcinoma: Analysis According to Gender, Race, Stage, Grade, and Histology. Eur Urol Focus. 2021 May;7(3):644-652. doi: 10.1016/j.euf.2020.05.003. Epub 2020 May 23.
PubMed 32456993Capitanio U, Bensalah K, Bex A, Boorjian SA, Bray F, Coleman J, Gore JL, Sun M, Wood C, Russo P. Epidemiology of Renal Cell Carcinoma. Eur Urol. 2019 Jan;75(1):74-84. doi: 10.1016/j.eururo.2018.08.036. Epub 2018 Sep 19.
PubMed 30243799
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Study of Stereotactic Body RadioTherapy (SBRT) With Continuous Tracking for Inoperable Patients With Primary and Secondary Renal Cancer (SBRTRC)
- ClinicalTrials.gov ID
- NCT07285538
- Acronym / sponsor ID
- SBRTRC / SBRTRC
- Keywords
- Renal primary tumors, Renal secondary tumors, stereotactic body radiotherapy, stereotactic ablative radiotherapy, Renal toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 15 Jan 2033 (estimated)
- Study completion
- 15 Jan 2033 (estimated)
- First posted
- 16 Dec 2025 (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 is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (standard prescriptions for the internationl guidelines, according to tumor size), using a robotic accelerator -CyberKnife® (Accuray, Sunnyvale, CA)-, with fiducial-tracking, to observe the acute and late toxicity reduction (as primary objectives), due to the maximum precision of the treatment. Secondary objectives are Local Relpase-Free Survival (LRFS), Regional Relapse-Free Survival (RRFS), Distant Metastasis-Free Survival (DMFS), Disease-Free Survival (DFS), Cancer Specific Survival (CSS), Overall Survival (OS) and Quality-of-Life (QoL). A total of 60 participants are expected to be enrolled over four years, and the follow-up of enrolled patients will be three years.
Detailed description
Renal Cell Carcinoma (RCC) is the eighth most common cancer diagnosed in Europe, with a rising incidence, particularly in old patients. The standard of care for operable patients with primary RCC is surgical resection, however, not all patients are suitable candidates for surgery. Alternative approaches, such as thermal ablation, present significant limitations, as reduced efficacy for lager tumors (>3-4 cm) and those located near the renal hilum.
Traditionally, Radiotherapy (RT) has not been considered an effective treatment for RCC due to its perceived radioresistance. High dose radiation therapy RCC leads to both direct cancer cell death and indirect cancer death from vasculature disruption.
The paradigm of radioresistance has shifted significantly with the advent of stereotactic body radiotherapy/ ablative radiotherapy (SBRT/SABR), which has demonstrated promising efficacy in local control while preserving renal function. The radiosensitivity varies in laboratory studies, with low α/β values (2.6 Gy - 6.9 Gy), thus RCC's lines are more responsive to increased radiation fraction size.
SBRT is non-invasive, delivers high doses with precision, using a steep dose gradient over a small number of treatment sessions. This approach has recently demonstrated promising local control (LC), and acceptable toxicity, even for large tumors.
IROCK (the International Radiosurgery Consortium of the Kidney) included 223 patients pooled from nine institutions, with a median follow up of 30 months. No difference in LC and toxicity was observed between patients receiving single fraction SBRT at 25 Gy (range 14-26 Gy) and multiple fractions SBRT at a median of 40 Gy (range 24-70 Gy) in four fractions was observed.
In 2022, IROCK reported the 5-year outcomes of 190 patients with primary RCC. The 7-year cumulative local failure rate was 8.4%, with no significant difference in the incidence of grade ≥2 between single fraction SBRT (5%) and multi-fraction SBRT (6%).
The TransTasman Radiation Oncology Group (TROG) 15.03 FASTRACK II trial was a non-randomized, phase 2, multicenter study with 71 pts enrolled, and 70 underwent SBRT. Treatment was delivered according to tumor size, with 23 patients (33%) received a single- fraction dose of 26 Gy (for tumors ≤ 4 cm) and 47 patients received 42 Gy in 3 fractions (for tumors >4 and ≤10 cm). Median follow up was 43 months. Local Control was 100%, with no observed local failures during the study protocol. Cancer specific survival was 100%, while freedom from distant failure was 97% at 36 months. Overall Survival was 82% at 36 months. SBRT was well tolerated with no grade 4 or 5 adverse events. The systematic review conducted for the International Society of Stereotactic Radiosurgery (ISRS) guidelines analyzed 36 studies with 822 patients. The median LC was 94.1 % (range 70-100%), 5-year progression-free survival was 80.5 % (range 72-92%), and 5- year Overall Survival was 77.2 %. SBRT was associated with minimal impact on renal function, with only a 3.9% of patients requiring post treatment dialysis across studies. Abancourt et al. analyzed 144 patients treated between 2008 and 2020, mainly with 26 Gy/ 1 fraction and 42 Gy/ 3 fractions, and with a 43 month median follow-up (IQR 24-81.2) local control at 5 years was 96%. Overall survival was 58 months and 5-year cumulative incidence of cancer related deaths was 8% (95% CI 3-15%). As much as 49% of patients experienced at least one toxicity, of which 32% were grade 1, 14% grade 2 and 1% grade 3. Two patients (1%) underwent dialysis. Median eGFR loss was 7 ml/min (IQR -17; 0) at the last follow-up.
The proposed clinical study involves a cutting-edge dose delivery method and a precise treatment planning. The high-dose conformation and real-time imaging accuracy for target identification and adjustment during treatment ensure the validity of this approach.
The treatment will be performed according to current guidelines. For primary disease definitive radiation therapy using SBRT will be considered as a treatment option for non-optimal surgical candidates, for patients with T1 tumors (<10 cm in diameter, according to FASTRACK II trial). SBRT will be delivered using 1-5 fractions. Dose and fractionation options will attempt to keep the biologically effective dose (BED) to ≥80 Gy assuming an α/β ratio of 10 due to association with improved local control.
This is a prospective, interventional, monocentric, clinical study of SBRT for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 40-50 Gy/5 fractions (according to tumor size), using CyberKnife with fiducial-tracking. The primary objective is acute and late toxicity reduction, due to the maximum precision of the treatment. Secondary objectives concern loco-regional and distant control, overall and specific survival, quality-of-life.
The study plans to enroll a total of 60 patients, needed for the ≥ G2 toxicity analysis , according to the study design, and with 20% compensation for potential drop-outs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A total of 60 patients are expected to be enrolled in this prospective, non-randomized study. For the sample size calculation, a power of 80% and a significance level (α) of 5% are set. The hypothesis is that the proportion of patients free from ≥G2 toxicity 3 years after the end of treatment is less than or equal to 13% which is inferior to the ≥G2 toxicity of 36% registered in the FASTRACK II trial. Considering a simple proportion study a total of 60 patients are required, including an additional 20% to compensate for potential drop-outs (relative to toxicity outcome). In case of reaching toxicity and local control objectives the study will be closed after another two years of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Prospective, interventional, monocentric, clinical study of SBRT for primary/secondary renal tumor | Experimental | Radiation: Stereotactic body radiotherapy (SBRT)SBRT to renal lesions will be delivered using 1-5 fractions. Dose and fractionation options will attempt to keep the biologically effective dose (BED) to ≥80 Gy assuming an α/β ratio of 10 due to association with improved local control. Established dosing regimens include: * 25-26 Gy in 1 fraction, for lesion in the greatest diameter (or sum of diameters in case of multiple lesions) up to 4 cm of maximum diameter * 42-48 Gy in 3-4 fractions, for lesion in the greatest diameter (or sum of diameters in case of multiple lesions) up to 6 cm of maximum diameter * 40-50 Gy in 5 fractions, for lesion larger than 6 cm in the greatest diameter (or sum of diameters in case of multiple lesions) For multi-fraction dosing, treatment will be delivered on consecutive or alternate days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or clinical diagnosis of primary or secondary kidney tumors
- Patients aged ≥18 years
- Signed informed consent
- Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions)
- PS (ECOG) ≤2
Key exclusion criteria (8 listed)
- Patients aged < 18 years
- Tumors > 10 cm
- PS ECOG ≥3
- Psychiatric or other disorders that may prevent the patient from signing informed consent
- Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)
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 |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)SBRT for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (according to tumor size), using CyberKnife | Radiation | Prospective, interventional, monocentric, clinical study of SBRT for primary/secondary renal tumor |
Primary outcome
Acute toxicity
Time frame: 3 months
Acute toxicity grade ≥2 as the maximum toxicity value at 3 months after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
Late toxicity
Time frame: 3 years
Late toxicity grade ≥2 as the maximum toxicity value at 3 years after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
7 secondary outcomes
Local control of the treated lesion (LC)
Time frame: 3 years
Local Relapse-Free Survival (time to local recurrence, LRFS)
Time frame: 3 years
Regional Relapse-Free Survival (RRFS)
Time frame: 3 years
Distant Metastases-Free Survival (DMFS)
Time frame: 3 years
Disease-Free Survival (local, regional, distant, DFS)
Time frame: 3 years
Cancer Specific Survival (CSS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
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 27 Oct 2026.
- Results publication: PubMed 39920013Abancourt L, Ali M, Quivrin M, Wallet J, Schick U, Ingrosso G, Supiot S, Franzese C, Scorsetti M, Kerkmeijer L, Fodor A, Muzio ND, Jousset N, Boisserie T, Detti B, Nicosia L, Alongi F, Trippa F, Leleu T, Dessoude L, Terlizzi M, Blanchard P, Scher N, Toledano A, Baude J, Lartigau E, Barthoulot M, Siva S, Pasquier D. Results of Stereotactic Body Radiation Therapy for Primary Renal Cell Carcinoma in a Large Multicenter Series. Eur Urol Oncol. 2025 Jun;8(3):774-781. doi: 10.1016/j.euo.2025.01.001. Epub 2025 Feb 7.
- Results publication: PubMed 38423047Siva S, Bressel M, Sidhom M, Sridharan S, Vanneste BGL, Davey R, Montgomery R, Ruben J, Foroudi F, Higgs B, Lin C, Raman A, Hardcastle N, Hofman MS, De Abreu Lourenco R, Shaw M, Mancuso P, Moon D, Wong LM, Lawrentschuk N, Wood S, Brook NR, Kron T, Martin J, Pryor D; FASTRACK II Investigator Group. Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial. Lancet Oncol. 2024 Mar;25(3):308-316. doi: 10.1016/S1470-2045(24)00020-2.
- Results publication: PubMed 36400098Siva S, Ali M, Correa RJM, Muacevic A, Ponsky L, Ellis RJ, Lo SS, Onishi H, Swaminath A, McLaughlin M, Morgan SC, Cury FL, Teh BS, Mahadevan A, Kaplan ID, Chu W, Grubb W, Hannan R, Staehler M, Warner A, Louie AV. 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis from IROCK (the International Radiosurgery Consortium of the Kidney). Lancet Oncol. 2022 Dec;23(12):1508-1516. doi: 10.1016/S1470-2045(22)00656-8. Epub 2022 Nov 16.
- Results publication: PubMed 29266183Siva S, Louie AV, Warner A, Muacevic A, Gandhidasan S, Ponsky L, Ellis R, Kaplan I, Mahadevan A, Chu W, Swaminath A, Onishi H, Teh B, Correa RJ, Lo SS, Staehler M. Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK). Cancer. 2018 Mar 1;124(5):934-942. doi: 10.1002/cncr.31156. Epub 2017 Dec 20.
- Results publication: PubMed 35843777Ali M, Mooi J, Lawrentschuk N, McKay RR, Hannan R, Lo SS, Hall WA, Siva S. The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. Eur Urol. 2022 Dec;82(6):613-622. doi: 10.1016/j.eururo.2022.06.017. Epub 2022 Jul 14.
- Results publication: PubMed 30352550Siva S, Chesson B, Bressel M, Pryor D, Higgs B, Reynolds HM, Hardcastle N, Montgomery R, Vanneste B, Khoo V, Ruben J, Lau E, Hofman MS, De Abreu Lourenco R, Sridharan S, Brook NR, Martin J, Lawrentschuk N, Kron T, Foroudi F. TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II. BMC Cancer. 2018 Oct 23;18(1):1030. doi: 10.1186/s12885-018-4916-2.
- Results publication: PubMed 36383304Rich BJ, Noy MA, Dal Pra A. Stereotactic Body Radiotherapy for Localized Kidney Cancer. Curr Urol Rep. 2022 Dec;23(12):371-381. doi: 10.1007/s11934-022-01125-6. Epub 2022 Nov 16.
- Results publication: PubMed 39123406Moreno-Olmedo E, Sabharwal A, Das P, Dallas N, Ford D, Perna C, Camilleri P. The Landscape of Stereotactic Ablative Radiotherapy (SABR) for Renal Cell Cancer (RCC). Cancers (Basel). 2024 Jul 27;16(15):2678. doi: 10.3390/cancers16152678.
- Results publication: PubMed 38181809Siva S, Louie AV, Kotecha R, Barber MN, Ali M, Zhang Z, Guckenberger M, Kim MS, Scorsetti M, Tree AC, Slotman BJ, Sahgal A, Lo SS. Stereotactic body radiotherapy for primary renal cell carcinoma: a systematic review and practice guideline from the International Society of Stereotactic Radiosurgery (ISRS). Lancet Oncol. 2024 Jan;25(1):e18-e28. doi: 10.1016/S1470-2045(23)00513-2.
- Results publication: PubMed 32456993Palumbo C, Pecoraro A, Knipper S, Rosiello G, Luzzago S, Deuker M, Tian Z, Shariat SF, Simeone C, Briganti A, Saad F, Berruti A, Antonelli A, Karakiewicz PI. Contemporary Age-adjusted Incidence and Mortality Rates of Renal Cell Carcinoma: Analysis According to Gender, Race, Stage, Grade, and Histology. Eur Urol Focus. 2021 May;7(3):644-652. doi: 10.1016/j.euf.2020.05.003. Epub 2020 May 23.
- Results publication: PubMed 30243799Capitanio U, Bensalah K, Bex A, Boorjian SA, Bray F, Coleman J, Gore JL, Sun M, Wood C, Russo P. Epidemiology of Renal Cell Carcinoma. Eur Urol. 2019 Jan;75(1):74-84. doi: 10.1016/j.eururo.2018.08.036. Epub 2018 Sep 19.
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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.
Nadia G Di Muzio, Prof. 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?
A study testing Stereotactic body radiotherapy (SBRT) in people with Renal Cancer and Renal Secondary Cancer, 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 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 (+39 0226437634, fodor.andrei@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: 3 months). The study lists 2 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 NCT07285538, which also lists 11 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 27 Oct 2026.