Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer (NCT07285538) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Italy60 participantsStarted 2026-01-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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)