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Taking people in ItalyNo phase

Precise radiation treatment for kidney cancer in people who cannot have surgery

Tests tracked, high-precision radiation for kidney tumors in adults who cannot have surgery.

Plain-language title generated from the registry record
Registry title: Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer

Key facts

Where
Milan, ItalySee the site

Where in Italy

  • Department of Radiation Oncology, IRCCS San Raffaele Scientific InstituteMilan, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
IRCCS San Raffaele
Trial code
NCT07285538
Record updated
27 October 2026
Original description
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 full original descriptionShow less

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.

Inclusion: 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).

Exclusion: 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; Patients aged < 18 years; Tumors > 10 cm; PS ECOG ≥3; Pregnant women.

ClinicalTrials.gov NCT07285538