Clinical trial · Interventional
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
A Prospective Interventional Study of Stereotactic Body RadioTherapy (SBRT) With Continuous Tracking for Inoperable Patients With Primary and Secondary Renal Cancer (SBRTRC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cancer | — | UNRESOLVED | — |
| Renal Secondary Cancer | — | UNRESOLVED | — |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prospective, interventional, monocentric, clinical study of SBRT for primary/secondary renal tumor
- description
- 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.
- interventionNames
- Radiation: Stereotactic body radiotherapy (SBRT)
Primary outcomes (2)
- measure
- Acute toxicity
- timeFrame
- 3 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological or clinical diagnosis of primary or secondary kidney tumors 2. Patients aged ≥18 years 3. Signed informed consent 4. Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions) 5. PS (ECOG) ≤2 6. No prior local radiotherapy 7. Fertile women using contraception methods previously initiated (a pregnancy test will be prescribed) Exclusion Criteria: 1. Patients aged \< 18 years 2. Tumors \> 10 cm 3. PS ECOG ≥3 4. Psychiatric or other disorders that may prevent the patient from signing informed consent 5. 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) 6. Pregnant women 7. Collagen diseases 8. Sjogren's syndrome
References
Publications (11)
- RESULTAbancourt 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
- RESULTSiva 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
- RESULTSiva 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
- RESULTSiva 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
- RESULTAli 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.