Stereotactic Body Radiotherapy with Continuous Tracking for Kidney Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center interventional study evaluating SBRT with fiducial tracking for primary or secondary renal tumors. Participants receive high-dose, few-fraction radiation (25-26 Gy in 1 fraction up to 40-50 Gy in 5 fractions, or 42-48 Gy in 3-4 fractions, depending on tumor size) delivered with a CyberKnife system to maximize precision and minimize toxicity. Primary endpoints focus on acute and late toxicity; secondary endpoints include relapse-free survival metrics, cancer-specific and overall survival, and quality of life, with a total enrollment of 60 patients and three years of follow-up. Eligible patients are adults with renal tumors up to 10 cm, good performance status, and no prior local radiotherapy to the kidney. The study aims to establish SBRT as a viable non-surgical option for patients who are not candidates for surgery or thermal ablation.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
  Milan, Milano (MI), Italy Recruiting

Study contacts

• Principal investigator: Nadia G Di Muzio, Prof. — IRCCS San Raffaele Scientific Institute
• Study coordinator: Andrei Fodor, MD
• Email: fodor.andrei@hsr.it
• Phone: +39 0226437634

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.