Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer

NCT07285538 | Not Yet Recruiting DMC

• 1 other identifier: SBRTRC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Renal Cancer; Renal Secondary Cancer; Stereotactic Body Radiotherapy

Keywords

Renal primary tumors; Renal secondary tumors; stereotactic body radiotherapy; stereotactic ablative radiotherapy; Renal toxicity

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 years

Secondary Outcomes (7)

• Local control of the treated lesion (LC)

  3 years

• Local Relapse-Free Survival (time to local recurrence, LRFS)

  3 years

• Regional Relapse-Free Survival (RRFS)

  3 years

• Distant Metastases-Free Survival (DMFS)

  3 years

• Disease-Free Survival (local, regional, distant, DFS)

  3 years

Other Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events as assessed with tumor specific quality of life questionnaires

  3 years

• Organ motion

  Perioperative/periprocedural

• Clinical and dosimetric prognostic factors

  3 years

Study Arms (1)

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.

Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

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

Prospective, interventional, monocentric, clinical study of SBRT for primary/secondary renal tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute

Milan, Milano (MI), 20073, Italy

Location

Related Publications (11)

• 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.

  PMID: 39920013 RESULT

• Siva 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.

  PMID: 38423047 RESULT

• Siva 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.

  PMID: 36400098 RESULT

• Siva 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.

  PMID: 29266183 RESULT

• Ali 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.

  PMID: 35843777 RESULT

• Siva 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.

  PMID: 30352550 RESULT

• Rich 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.

  PMID: 36383304 RESULT

• Moreno-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.

  PMID: 39123406 RESULT

• Siva 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.

  PMID: 38181809 RESULT

• Palumbo 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.

  PMID: 32456993 RESULT

• Capitanio 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.

  PMID: 30243799 RESULT

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nadia G Di Muzio, Prof.

  IRCCS San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei Fodor, MD

CONTACT

+39 0226437634; fodor.andrei@hsr.it

Nadia G Di Muzio, Prof.

CONTACT

+390226437643; dimuzio.nadia@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 16, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2033
• Study Completion (Estimated): January 15, 2033
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

IT (1)