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NCT07285538Recruiting

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 · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
26 Nov 2025
Start date
14 Sept 2026
Primary completion date
15 Jan 2033
Lead sponsor
IRCCS San Raffaele
NCT number
NCT07285538

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 14 Sept 2026 to the primary completion date, 15 Jan 2033
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)
  • Collagen diseases
  • Sjogren's syndrome

Age

  • Patients aged \< 18 years

Other

  • Tumors \> 10 cm
  • PS ECOG ≥3
  • Pregnant women

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.